National Security Commission on Emerging Biotechnology’s Final Report Includes Recommendations to Boost Economy and Protect National Security
The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” After an extensive study that included “more than 1,800 stakeholder consultations, a holistic review of unclassified and classified material, site visits across the United States, and meetings with foreign government and technology leaders,” NSCEB developed a set of top-priority recommendations to ensure that the United States “outrun[s] and slow[s] down Beijing in the biotechnology race.” The principles for action include:
Promote U.S. biotechnology innovation;
Be the biotechnology partner of choice for the world;
Use national security tools to protect innovation and industrial base in biotechnology; and
Work with the international community, including China where prudent, to develop best practices and standards for biosafety and biosecurity to prevent against misuse, whether deliberate or accidental.
The report states that after an extensive study, “including more than 1,800 stakeholder consultations, a holistic review of unclassified and classified material, site visits across the United States, and meetings with foreign government and technology leaders,” NSCEB developed the following set of top-priority recommendations:
Pillar 1: Prioritize biotechnology at the national level:
1.1a Congress must establish a National Biotechnology Coordination Office (NBCO) within the Executive Office of the President with a director, appointed by the President, who would coordinate interagency actions on biotechnology competition and regulation.
Pillar 2: Mobilize the private sector to get U.S. products to scale:
2.1a Congress must direct federal regulatory agencies to create simple pathways to market and exempt familiar products from unnecessary regulation;
2.2a Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology startups that strengthen U.S. national and economic security;
2.3a Congress must authorize and fund the U.S. Department of Energy (DOE) and the U.S. Department of Commerce to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up;
2.4a Congress must direct the Department of Homeland Security (DHS) to ensure that biotechnology infrastructure and data are covered under “critical infrastructure”;
2.5a Congress must require public companies to disclose single points of supply chain vulnerability located in foreign countries of concern; and
2.5b Congress must prohibit companies that work with U.S. national security agencies and the U.S. Department of Health and Human Services (DHHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.
Pillar 3: Maximize the benefits of biotechnology for defense:
3.1a Congress must direct the U.S. Department of Defense (DOD) to consult with stakeholders to define principles for ethical use of biotechnology for the U.S. military;
3.2a Congress must direct the DOD to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for DOD needs; and
3.3a Congress must require outbound investment rules to ensure that U.S. capital does not support Chinese development of certain biotechnologies that could pose a national security risk.
Pillar 4: Out-innovate our strategic competitors:
4.1a Congress must authorize the DOE to create a Web of Biological Data (WOBD), a single point of entry for researchers to access high-quality data;
4.2a Congress must conduct oversight of existing policies, and add new ones where warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States;
4.3a Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges; and
4.4a Congress must direct the executive branch to advance safe, secure, and responsible biotechnology research and innovation.
Pillar 5: Build the biotechnology workforce of the future:
5.1a Congress must direct the Office of Personnel Management (OPM) to provide workforce training in biotechnology across the interagency;
5.1b Congress must ensure that federal agencies have the necessary expertise across national security and emerging biotechnology issues; and
5.2a Congress must maximize the impact of domestic biomanufacturing workforce training programs.
Pillar 6: Mobilize the collective strengths of our allies and partners:
6.1a Congress must include biotechnology in the scope of the U.S. Department of State’s International Technology Security and Innovation Fund to fund appropriately international biotechnology policy, research and development (R&D), and secure supply chains.
France’s Limagrain Wins Highest Chinese Damages Ever for New Plant Varieties Infringement – Over 53 Million RMB
On April 25, 2025, China’s Intellectual Property Court of the Supreme People’s Court (SPC) announced a verdict favoring Limagrain’s Chinese affiliate Heng XX Seed Industry Co., Ltd. against Henan Jin XX Seed Industry Co., Ltd. The SPC awarded Limagrain’s affiliate over 53 million RMB and an injunction for infringing new corn plant variety “NP01154” overturning the lower court’s decision and applying punitive damages. This is believed to be the highest ever award in China for new plant varieties infringement.
Heng XX Company filed a lawsuit with the first instance court, claiming that the seven approved corn hybrid varieties produced and sold by Jin XX Company, including “Zheng Pinyu 491”, “Jinyuanyu 304”, “Jinyuanyu 171”, “Zheng Pinyu 597”, “Jinyuanyu 181”, “Zhengyuanyu 777” and “Zhengyuanyu 887”, were all produced without permission using the “NP01154” variety as a parent, and requested that it be ordered to stop the infringement, apply punitive damages of 160 million RMB and pay 200,000 RMB for reasonable expenses for rights protection. In the first instance, Heng XX Company submitted four test reports to prove that the number of difference sites between the parents of the alleged infringing variety “YZ320” and “NP01154” was 1, and therefore was infringing; Jin XX Company submitted test report No. 2994 and claimed that there were differences in 4 of the 5 additional test sites, and the two were different varieties, so it did not constitute infringement. The first instance court accepted the test report No. 2994 submitted by Jin XX Company, determined that the parent of the alleged infringing variety “YZ320” and the authorized variety “NP01154” were different varieties, and ruled to dismiss all the claims of Heng XX Company. Heng XX Company appealed.
The focus of the second-instance dispute was whether Jin XX infringed the variety rights of “NP01154” and the determination of infringement liability, which mainly involved whether the parents (paternal parents) of the seven hybrid corn varieties accused of infringement were identical to the authorized variety “NP01154”. In particular, when using molecular markers to determine the identity of the variety, the conditions for expanding the site testing and the probative value of the additional testing results were the key issues in this case.
The Supreme People’s Court held that there was insufficient evidence to prove that the five additional test sites in the No. 2994 test report were generally recognized specific sites that could distinguish different varieties. The report’s initiation of the expanded site testing procedure and the selection of additional test sites did not comply with the provisions of the relevant judicial interpretations and the requirements of the molecular marker testing standards for new plant varieties, and had no probative value. Jin XX’s claim that its allegedly infringing variety was “glutinous” corn and that the authorized variety “NP01154” was “ordinary corn” and that the two were different varieties lacked evidence. The evidence in this case can prove that the parents (father) of the seven hybrid corn varieties accused of infringement are identical to the authorized varieties, and Jin XX’s behavior constitutes infringement of the “NP01154” variety rights; Jin XX’s company intentionally infringed, and the infringing products involve 7 approved hybrid varieties, the infringement period is as long as five years, and the infringing production area is as high as 8243.4 acres. The infringement is serious, and punitive damages should be applied, and the multiple of punitive damages is determined to be 1X, and then the total compensation is determined to be twice the amount of compensatory damages, that is, more than 53.347 million RMB. In view of the complexity of the case and the evidence, Heng XX’s attorney fees, testing fees, travel expenses and other expenses are reasonable, and the reasonable expenses of 200,000 RMB for rights protection are fully supported. The final compensation amount in this case is 53,547,163.1 RMB.
The original text of the announcement is available here (Chinese only).
McDermott+ Check-Up: April 25, 2025
THIS WEEK’S DOSE
HELP Committee Releases 340B Report. Health, Education, Labor, and Pensions (HELP) Chair Cassidy (R-LA) released findings from his investigation and laid out potential reforms to the 340B Drug Pricing Program.
CMS Releases FY 2026 Medicare IPPS Proposed Rule. The Centers for Medicare and Medicaid Services’ (CMS’s) fiscal year (FY) 2026 hospital Inpatient Prospective Payment System (IPPS) proposed rule includes payment updates, proposals related to the Transforming Episode Accountability Model, and deregulation.
CMS Releases Additional FY 2026 Medicare Proposed Rules. The rules would update the hospice wage index and the skilled nursing facility, inpatient psychiatric facility, and inpatient rehabilitation facility prospective payment systems.
President Trump Signs EO on Lowering Drug Prices. The executive order (EO) includes directives to lower Medicare drug prices and reduce anticompetitive behavior.
Administration Acts on Gender-Affirming Care. A CMS letter reminded states of existing Medicaid requirements, a separate US Department of Justice memo outlined potential future action, and the US Department of Health and Human Services (HHS) created an online portal for whistleblowers.
President Trump Sends Memo on Immigrants’ Use of Medicare and Medicaid Benefits. Various departments, including HHS, were directed to ensure ineligible immigrants do not receive benefits.
NIH Releases New Grant Guidelines. The National Institutes of Health (NIH) expanded the actions that are prohibited by antidiscrimination laws.
Administration Continues Federal Workforce Restructuring. The latest proposal seeks to create a new class of at-will civil service employees.
President Trump Issues EO on Higher Education Accreditation. The directive includes medical school accreditation reforms.
CONGRESS
HELP Committee Releases 340B Report. The report includes findings from Chair Cassidy’s long-running investigation into the 340B program that looked at two hospitals, two federally qualified community health centers, two contract pharmacies, and two drug manufacturers. The report highlights five potential reforms for Congress to consider:
Requiring covered entities to provide detailed annual reporting on how 340B revenue is used to ensure direct savings for patients, creating more transparency into the link between program savings and patient benefit.
Addressing potential logistical challenges caused by increased administrative complexity; these burdens may impede patient benefit from the program.
Investigating the types of financial benefits that contract pharmacies and third-party administrators (TPAs) receive for administering the 340B program to ensure that increasing fees do not disadvantage covered entities and patients.
Requiring transparency and data reporting for entities supporting participants in the 340B program (i.e., contract pharmacies and TPAs).
Providing clear guidelines to ensure that manufacturer discounts actually benefit 340B-eligible patients and examining legislative changes to the definition of eligible patient and contract pharmacies’ use of the inventory replenishment model.
ADMINISTRATION
CMS Releases FY 2026 Medicare IPPS Proposed Rule. The rule, released April 11, 2025, proposes a 2.4% payment rate. A fact sheet is available here.
New proposals include:
Updates to the Transforming Episode Accountability Model (TEAM), which would remain a five-year mandatory model but would include a limited deferment for certain hospitals, neutral scoring on quality for hospitals with insufficient quality data, changes to the payment methodology and risk adjustment, and expansion of the skilled nursing facility (SNF) three-day-rule waiver. The model is slated to begin on January 1, 2026.
A request for comments on future quality measures supporting the Make America Healthy Again priorities of well-being and nutrition and on proposals to remove quality measures on health equity and social determinants of health.
A deregulation request for information (RFI) on ways to streamline regulations, reduce administrative burdens, and identify duplicative requirements across the Medicare program. Responses should be submitted through a web-based form, separate from other comments on the rule.
CMS Releases Additional FY 2026 Medicare Proposed Rules. Additional proposed regulations were released on April 11, 2025. These rules include the same deregulation and quality measure RFIs that were included in the IPPS proposed rule.
Key takeaways include:
Hospice Wage Index. CMS proposes to increase rates by 2.4% and clarify technical certification regulations.
SNF Prospective Payment System (PPS). CMS proposes to increase rates by 2.8% and implement operational and administrative updates to the SNF value-based purchasing program.
Inpatient Psychiatric Facility (IPF) PPS. CMS proposes to increase rates by 2.4% and issued an RFI on the IPF quality reporting program.
Inpatient Rehabilitation Facility (IRF) PPS. CMS proposes to increase rates by 2.6% and remove social determinants of health patient assessment data elements from the IRF quality reporting program.
Comments on the hospice wage index and SNF PPS are due by June 29, 2025, and comments on IPF PPS and IRF PPS are due by June 10, 2025.
President Trump Signs EO on Lowering Drug Prices. The EO directs HHS to:
Seek comment within 60 days on revisions to the Medicare Drug Price Negotiation Program for initial price applicability in 2028.
Coordinate with Congress to address the timing disparity between small-molecule and biologic drugs.
Conduct a survey to determine hospital acquisition costs for outpatient drugs and propose adjustments.
Condition health center grant funding on providing insulin and injectable epinephrine at or below the 340B acquisition cost, plus a minimal administrative fee.
Address payment incentives that encourage shifting of drug administration volume from physician offices to hospital outpatient departments.
The EO directs the CMS Innovation Center to develop a model for high-cost Medicare-covered drugs and biologicals. It also calls on agencies to develop recommendations to reduce anticompetitive behavior from drug manufacturers. Read the fact sheet here.
Administration Acts on Gender-Affirming Care. Pursuant to President Trump’s January EO on gender-affirming care for children, “Protecting Children from Chemical and Surgical Mutilation,” CMS sent a state Medicaid director letter. It states that the use of medical interventions for gender dysphoria in children has increased in recent years and that such interventions can cause long-term harm. The letter reminds states of existing federal requirements, including to ensure care is provided in the best interests of recipients. It reiterates that states must develop a drug utilization review (DUR) program that ensures drugs are appropriate, medically necessary, and not likely to result in adverse outcomes. CMS encourages states to review their DUR programs and indicates there will be additional DUR guidance in the future. Read more in a statement from CMS Administrator Oz.
HHS launched an online portal where whistleblowers can submit a tip or complaint regarding gender affirming care for minors. Read the press release here.
The US Department of Justice issued a memo outlining potential future actions in this arena, including:
Enforcement of laws outlawing female genital mutilation.
Investigation of violations of the Food, Drug, and Cosmetic Act and False Claims Act.
Withdrawal of any regulatory action based on World Professional Association for Transgender Health guidelines.
Establishment of the Attorney General’s Coalition Against Child Mutilation.
Legislation that bans gender-affirming care for minors.
President Trump Sends Memo on Immigrants’ Use of Medicare and Medicaid Benefits. With regard to healthcare programs, the memo:
Directs the heads of HHS, the US Department of Labor, and the Social Security Administration to take all reasonable measures to ensure ineligible immigrants do not receive funds from Social Security Act programs, which include Medicare and Medicaid.
Directs the attorney general and HHS secretary to ramp up fraud prosecution for all CMS programs.
Directs the social security commissioner, with the HHS secretary’s cooperation, to ensure death information is up to date.
On April 16, 2025, it was reported that officials from Immigration and Customs Enforcement and the Department of Government Efficiency sought access to a CMS database that includes health and personal information of beneficiaries, including immigrants.
NIH Releases New Grant Guidelines. In its Notice of Civil Rights Term and Condition of Award update (NOT-OD-25-090), NIH alerted domestic recipients that when accepting NIH grant funding, recipients must now certify that they are not in violation of federal antidiscrimination laws. Specifically, the notice highlights that such violations include operation of diversity and equity programs, engaging in “discriminatory equity ideology,” and participation in any prohibited boycott of businesses. Based on the memo, the NIH can terminate financial assistance and recover funds from recipients that engage in prohibited conduct.
Administration Continues Federal Workforce Restructuring. An Office of Personnel Management proposed rule seeks to create a new category of federal employees (“Schedule Policy/Career”) for employees with policy-influencing duties. These are not political appointees, and they currently have federal civil service protections. The new proposed category would remove these protections for an estimated 50,000 employees and instead make them “at-will,” which means agencies could remove them more quickly. Read the fact sheet here.
President Trump also issued a memo extending the hiring freeze on federal civilian employees through July 15, 2025.
President Trump Issues EO on Higher Education Accreditation. With regard to healthcare, the EO directs the attorney general and education secretary to terminate diversity, equity, and inclusion requirements advanced by the Liaison Committee on Medical Education, the Accreditation Council for Graduate Medical Education, or other accreditors of graduate medical education. The EO also directs the education secretary to assess whether to suspend or terminate the council’s status as an accreditation agency. Read the fact sheet here.
QUICK HITS
Vulnerable House Republicans Express Concerns About Medicaid Cuts. A group of 12 House Republicans sent a letter to House Republican leadership and Energy and Commerce Committee Chair Guthrie (R-KY) stating that they will not vote for any reconciliation bill that reduces Medicaid coverage for children, seniors, individuals with disabilities, or pregnant women, although they emphasized their support for targeted reforms.
FTC Issues RFI on Anticompetitive Regulations. In response to President Trump’s EO on “Reducing Anticompetitive Regulatory Barriers,” the Federal Trade Commission (FTC) launched a public inquiry into the impact of federal regulations on competition. The RFI invites members of the public to comment on how federal regulations can harm competition, and seeks to understand which federal regulations have an anticompetitive effect. Comments are due on May 27, 2025.
Commerce Department Launches Investigation Into Imports of Pharmaceuticals, Pharmaceutical Ingredients. The RFI announced that Commerce Secretary Lutnick initiated an investigation to determine the national security effects of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, key starting materials, and derivative products of those items. Comments are due on May 7, 2025.
House Republicans Launch American-Made Medicines Caucus. House Energy and Commerce Health Subcommittee Chair Carter (R-GA) and Reps. Tenney (R-NY) and Bilirakis (R-FL) announced the launch of a new caucus that will focus on ways to bring the pharmaceutical supply chain to the United States and become less dependent on China for pharmaceutical products.
FDA Limits Industry Employees From Advisory Committees. The policy directive limits individuals employed at companies regulated by the US Food and Drug Administration (FDA) from serving as official members on FDA advisory committees.
House Ways and Means Committee Members Send Letter to IRS. The letter from Committee Chair Smith (R-MO), Health Subcommittee Chair Buchanan (R-FL), and Rep. Panetta (D-CA) encourages Acting Internal Revenue Service (IRS) Commissioner Shapley to update and expand the IRS list of services and treatments for chronic diseases covered under an employer-sponsored high deductible health plan.
HHS Secretary Kennedy Focuses on Autism Spectrum Disorder. In a press conference, Kennedy highlighted recently released data from the Centers for Disease Control and Prevention that found an increased prevalence of Autism Spectrum Disorder. He stated that a large research effort would be underway, with findings published by September 2025, although NIH stated that its goal is just to award research grants by then. Read the press release here.
House Ways and Means Committee Republicans Issue RFI on OPOs. In an open letter, Chair Smith and Oversight Subcommittee Chair Schweikert (R-AZ) requested information on organ procurement organizations (OPOs) related to their operations, their allocation of resources, and the rules and regulations governing them. This RFI is part of the committee’s broader effort to examine OPOs’ potential violations of Medicare reimbursement rules and US tax law.
GAO Examines College Student Health Coverage. The US Government Accountability Office (GAO) report found that the percentage of college students with health insurance has increased by 11 percentage points in the last decade, but found that 1.6 million students still lack coverage. GAO identified barriers such as lack of Medicaid expansion and geographic limitations on coverage for students attending school out of state.
GAO Releases Reports on Defense Healthcare. The first report found that sepsis-related quality measures at medical facilities run by the US Department of Defense (DOD) have been improving. The second report recommended that DOD monitor mental health screenings for prenatal and postpartum TRICARE beneficiaries to ensure the recommended screenings are being provided.
NEXT WEEK’S DIAGNOSIS
Both chambers of Congress will be back in session next week, and the House plans to forge ahead on the reconciliation process during this upcoming work period. It’s being reported that the House Energy and Commerce Committee will mark up its reconciliation package on May 7, 2025, and House Republicans have indicated they plan to have a full bill on the floor the week of May 19, 2025. At the committee level, next week’s healthcare activities include:
House Education and Workforce Committee hearing on the Employee Retirement Income Security Act.
Senate Appropriations Committee hearing on US biomedical innovation.
House Oversight and Government Reform Cybersecurity, Information Technology, and Government Innovation Subcommittee hearing on government IT modernization.
House Veterans’ Affairs Oversight and Investigations Subcommittee hearing on the VA’s mental health policies.
We await the release of the Trump administration’s FY 2026 budget request, which is expected in the form of an abbreviated, or “skinny,” budget (as is common in a new administration) this month, followed by a full budget request at a later date. HHS confirmed that HHS Secretary Kennedy will testify in front of the Senate HELP Committee, likely after the skinny budget is released next month.
PBMs Score a Win in Federal Court Against State Regulation
A recent federal court decision has the potential to tip the balance in an ongoing series of skirmishes over state regulation of pharmacy benefit managers (PBMs).
In McKee Foods Corp. v. BFP Inc. d/b/a/ Thrifty Med Plus Pharmacy, the US District Court for the Eastern District of Tennessee declared that an “any willing pharmacy” requirement in Tennessee was preempted by the federal Employee Retirement Income Security Act of 1974 (ERISA), as amended. On one side, self-funded group health plans argue that ERISA allows them to comply with a single set of rules nationwide, rather than having to navigate a patchwork of different, overlapping, and sometimes conflicting state laws. On the other side are the states, which have a legitimate interest in ensuring prescription drug reimbursements are fair and reasonable and their citizens are protected from fraudulent, abusive, or misleading PBM practices. However, states have routinely misread a 2020 Supreme Court decision, Rutledge v. Pharmaceutical Care Management Association, to support extensive interference with the design and operation of employer-sponsored group health plans in a manner that may be preempted by ERISA.
In Depth
Enacted in 1974, ERISA made the regulation of employee benefit plans principally a matter of federal concern. The law broadly and generally preempts – or renders inoperative – state laws that “relate to” employee benefit plans. According to the Supreme Court’s Rutledge decision, ERISA preempts “any and all State laws insofar as they may now or hereafter relate to any employee benefit plan covered by ERISA.” To “relate to” an ERISA plan, a law must either have a “connection with” or “reference to” such a plan.
“Connection with” preemption arises when either a law requires providers to structure benefit plans in particular ways, or acute (albeit indirect) economic effects of the state law force an ERISA plan to adopt a certain scheme of substantive coverage.
“Reference to” preemption arises in a different set of circumstances, namely where a state’s law acts immediately and exclusively upon ERISA plans or where the existence of ERISA plans is essential to the law’s operation.
Citing Kentucky Association of Health Plans, Inc. v. Nichols, the McKee court held that Tennessee’s “any willing pharmacy” law had an impermissible connection with ERISA plans and was therefore preempted. In so holding, the court rejected the state of Tennessee’s reliance on Rutledge. Critically, Rutledge involved a form of cost regulation, not plan structure. By contrast, pharmacy networks – at issue in McKee – are plan structures.
McKee is consistent with the Tenth Circuit Court of Appeals decision in PCMA v. Mulready (now pending before the Supreme Court), which invalided an Oklahoma law compelling PBMs to comply with certain pharmacy network standards. The Tenth Circuit held that ERISA superseded the Oklahoma law because it generally compelled ERISA plans to structure benefits in certain ways. In reaching its decision, the Mulready court reviewed, summarized, and applied more than 20 years of Supreme Court jurisprudence, which can be summed up as follows: States have wide berth to regulate PBM pharmacy reimbursement rates and acquisition costs, but they may not interfere with plan operation and administration, including the design and structure of pharmacy networks.
Currently, fiduciaries and plan sponsors of self-funded group health plans with multistate operations are confronted with myriad conflicting and burdensome state PBM laws, as well as increased private plaintiff activity. Texas, Florida, and Arkansas are posing particular challenges at the moment; other states will likely follow. While MeKee is encouraging, it is of little help in the short run. To break the logjam, action is required, either by the Supreme Court or Congress.
FDA Releases Results from Bottled Water PFAS Testing
FDA recently shared the final results from the testing of domestic and imported bottled water collected at retail locations across the U.S. for per- and polyfluoroalkyl substances (PFAS). Of the 197 samples of purified, artesian, spring, and mineral waters tested, ten samples had detectable levels of PFAS. However, none of those had levels that would have exceeded the EPA’s maximum contaminant levels (MCLs) for PFAS in public drinking water.
PFAS are a diverse group of widely used, long lasting chemicals that do not easily break down and can accumulate in the environment and human tissues with negative health consequences. PFAS have been the subject of various testing efforts, lawsuits, and legislation.
In the bottled water study, FDA tested for 18 types of PFAS, including the six types with EPA-established MCLs. The ten samples with detectable PFAS levels contained a range of one to four different PFAS in domestic samples and one to two different PFAS in imported samples. Of these, four PFAS were below EPA MCLs for drinking water, and two PFAS detected do not have established MCLs.
The Food, Drug, and Cosmetic Act requires FDA to establish a standard of quality regulation for contaminants in bottled water whenever the EPA establishes MCLs for public drinking water as part of a National Primary Drinking Water Regulation. If FDA does not establish a standard for the contaminants or finds that such standards are not necessary to protect public health, then the EPA levels are considered the applicable regulation for bottled water. FDA can then take action against bottled water that presents a safety concern even if there is no standard of quality for a contaminant.
FDA Announces Phase-Out of What it Referred to as “Petroleum-Based Synthetic Food Dyes”
Yesterday, FDA and HHS announced a series of actions intended to phase out the use of petroleum-based synthetic food dyes. The news release can be found here and a video of the press conference here. Specifically, the agency announced that it would:
Establish a national standard and timeline to transition from petroleum-based dyes to natural alternatives.
Initiate the process to revoke authorizations for Citrus Red No. 2 (21 CFR 74.302) and Orange B (21 CFR 74.250).
Work with the industry to eliminate the remaining six synthetic dyes – Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2 – from the food supply by the end of the year.
Authorize four new natural color additives – calcium phosphate, Galdieria extract blue, gardenia blue, and buttery fly pea flower extract (expanded uses) –in the coming weeks and accelerate the review and approval of others.
Partner with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
Request that companies remove Red No. 3 sooner than the previously required 2027-2028 deadline.
Speakers at the press conference included HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. Sweeping claims about the harms of the dyes, in particular to children, were made. Although the health effects of many of the dyes have been brought into question, there is little scientific consensus on the subject. See e.g., CA Department of Public Health Rejection of Synthetic Dye Warnings. FDA has not released any document providing an explanation for the agency’s change in position or providing a risk assessment to support its position. The speakers also discussed variations of state additive bans and the market harms of patchwork state regulation.
Neither the press release nor the news conference referenced any formal process to revoke the authorizations for the synthetic food dyes that are not Citrus Red No. 2 and Orange B, and FDA will likely rely on voluntary phase out by industry and state additive bans to implement its plans.
FDA Suspends Food Safety Quality Checks Amid Staff Cuts
The U.S. Food and Drug Administration (FDA) has recently suspended its food safety quality checks due to significant staff cuts at the Department of Health and Human Services (HHS). FDA had been drawing up plans in anticipation of the staff cuts, and outsourcing oversight to state and local authorities. This decision has raised concerns about the potential impact on public health and food safety standards.
FDA’s proficiency testing program, part of the Food Emergency Response Network (FERN), is designed to ensure consistency and accuracy in food testing laboratories. The network comprises approximately 170 labs that test food for pathogens and contaminants to prevent foodborne illness.
The suspension of this program follows the firing and departure of up to 20,000 HHS employees, including key personnel such as quality assurance officers, analytical chemists, and microbiologists. The program will be suspended at least through September 30, 2025.
The staff cuts have also impacted FDA’s work in other areas such as its bird flu response and drug reviews. FDA had already suspended efforts to improve testing for bird flu in milk, cheese, and pet food earlier in April due to staffing issues.
Drug Pricing and Payment Executive Order Shows Trump Administration’s Cards
On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment reforms from President Trump’s first term, with a goal of curbing drug costs to patients. This offers a highly anticipated glimpse into the Administration’s position on drug manufacturers, Pharmacy Benefit Managers (PBMs) and providers.
Notably, the Executive Order endorses reforms to the Inflation Reduction Act (IRA), including the Medicare Prescription Drug Negotiation Program and the so-called “pill penalty.” The Executive Order also looks to expand on reimbursement reductions for hospitals that are critical participants in the drug supply chain. Below is an analysis of the Executive Order’s key components, including potential impacts and 340B Drug Pricing Program (340B Program) considerations.
1. Reforming Medicare Drug Price Negotiations under the IRA
The IRA, signed into law in 2022, included several provisions aimed at lowering prescription drug prices. One of the primary provisions in the IRA was the expansion of Medicare’s ability to negotiate prices for certain drugs covered under Medicare Parts B and D directly with pharmaceutical companies (Negotiation Program).1 Under President Biden, the Centers for Medicare & Medicaid Services (CMS) negotiated 2026 pricing for a list of 10 drugs. CMS projects roughly $6 billion in Medicare Part D savings ($1.5B for patients) attributed to the 2026 list. Unless Congress changes the IRA or the Trump Administration unwinds the CY 2026 pricing, those prices will go into effect on January 1, 2026. In early 2025, CMS identified a list of 15 additional products to negotiate for 2027—those price negotiations were originally set to occur in 2025.
The IRA restricts which drugs Medicare can select for price negotiations. A small-molecule drug product must be at least seven years past its FDA approval date to qualify for price negotiations and nine years past its FDA approval date before the negotiated price can take effect. A biologic drug must be at least 11 years past its FDA approval date to qualify for price negotiations, and 13 years past its FDA approval date before the negotiated price can take effect. Some in the industry have termed the four-year difference between when small-molecule drugs and biologics qualify for price negotiations as a “pill penalty,” a reference to the fact that small-molecule drugs are often marketed as orally available pills (i.e., tablets or capsules) whereas biologics are generally only available via parenteral routes of administration (i.e., via injection).
The Executive Order addresses these points, explaining that the Negotiation Program “has the commendable goal of reducing the drug prices Medicare and its beneficiaries pay,” but claims that “its administratively complex and expensive regime has thus far produced much lower savings than projected.” The Executive Order also discusses “the ‘pill penalty’” and says that it “threatens to distort innovation by pushing investment towards expensive biological products, which are often indicated to treat rarer diseases, and away from small molecule prescription drugs, which are generally cheaper and treat larger patient populations.”
The Executive Order includes directives aimed at improving the IRA, including that the Secretary of Health and Human Services (HHS) (the Secretary) “shall work with the Congress to modify the Negotiation Program to align the treatment of small molecule prescription drugs with that of biological products, ending the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries.” The Executive Order also directs the Secretary to “propose and seek comment on guidance for the Medicare Drug Price Negotiation Program for initial price applicability year 2028 and manufacturer effectuation of maximum fair price under such program in 2026, 2027 and 2028” by June 14, 2025. And the order directs Director of the Office of Management and Budget, the Secretary, and various policy advisors to “provide recommendations to the President on how best to stabilize and reduce Medicare Part D premiums” within 180 days of the order.
Finally, in a related initiative, the Administration directs the Secretary to use the Center for Medicare and Medicaid Innovation to develop “a payment model to improve the ability of the Medicare program to obtain better value for high-cost prescription drugs and biological products covered by Medicare, including those not subject to the Medicare Drug Price Negotiation Program” within one year of the Executive Order.
While the Executive Order didn’t formally eliminate prior price negotiation efforts, it will likely delay the government’s ability to negotiate lower prices for several of the most expensive prescribed drugs on the market as guidance is developed. 340B Covered Entities should track these developments as the required guidance could include more direction on implementation of the maximum fair price (MFP) and how CMS intends to address manufacturer and 340B Covered Entity concerns regarding the interplay between the MFP and 340B Program purchases.
2. Survey to Identify Hospital Drug Acquisition Costs and Develop Updated Drug Pricing Policies
Following years of litigation regarding a controversial 2018 CMS payment reduction for 340B drugs, a victory for 340B Covered Entities at the Supreme Court in June 2022, and lump sum payments as a remedy to 340B Covered Entities, the 340B Program rollercoaster continues for these safety net entities. The Executive Order requires the Secretary to publish a plan to conduct a hospital acquisition cost survey for covered outpatient drugs pursuant to Section 1833(t)(14)(D)(I) of the Social Security Act (the Act). Under Section 1833(t)(14), HHS may vary drug payment by hospital group if an acquisition cost survey is available. HHS lost its battle with 340B Covered Entities when it failed to demonstrate that it conducted a survey as required by the Act. It appears that the Executive Order is intending to address that deficiency so CMS can attempt to change drug payment rates.
While this is a developing issue, it appears the Trump Administration is trying to address this prior loss head on and revisit drug payment rates. Hospitals, particularly 340B Covered Entities, need to be prepared to address any survey method deficiencies (e.g., 340B pricing is confidential), and they need to be ready to respond to very challenging written survey requests. This is reminiscent of CMS’s survey attempt in April 2020 that was released on the heels of the COVID-19 pandemic. We are also monitoring the rumored shift of 340B Program oversight from the Health Resources and Services Administration (HRSA) to CMS, as that could play a significant role in this survey process and other 340B Program oversight functions.
3. Insulin and Epinephrine Discounts via Federally Qualified Health Centers (FQHCs)
The Executive Order instructs HHS to reinstitute a mandate that applies to insulin and injectable epinephrine acquired by FQHCs. The mandate would require FQHCs to provide these products to low-income patients (to be defined) at or below the 340B Program price, plus a minimal administration fee.
Many FQHCs already provide access to these products at heavily discounted pricing per their sliding fee scale policies developed pursuant to HRSA grant guidance. For many FQHCs, this policy may present operational challenges for products dispensed via contract pharmacies. Likewise, the Executive Order does not address situations where FQHCs are unable to obtain the dispensed products at 340B Program pricing, including due to shortages or manufacturers refusing to sell products at discounted prices. This policy may reignite tension between manufacturers and 340B Covered Entities, as drugmakers continue to restrict 340B pricing access on certain products. Because these operational and acquisition challenges could lead to significant losses, FQHCs need to remain involved in advocacy as any resulting policies are developed by HHS.
4. Site Neutral Payment Policy for Drug Administration Fees
The Executive Order directs the Secretary to evaluate and propose regulations to remove payment policies that incentivize providers to direct drug administration volume away from physician practices to hospital outpatient departments. While the Executive Order didn’t elaborate further, it’s likely that this directive is intended to target existing payment differences for drug administration codes when billed by provider-based hospital outpatient departments versus freestanding physician offices.
Hospitals, including 340B Covered Entities, should closely monitor this development. There is a history of bipartisan support for various site neutral policy proposals, and the directive may be a sign of more policies to come that may impact payment to and/or oversight of provider-based departments. Decreasing payment for drug administration services while also adjusting payments for the underlying drugs based on acquisition cost survey data discussed above could result in a substantial hospital payment reduction that could severely impact budgets. Such policy decisions would frustrate the intent of the 340B Drug Pricing Program.
5. Initiatives Impacting Manufacturers and PBMs
The Executive Order also includes initiatives that could impact drug manufacturers and PBMs and may require significant changes to their operations. These initiatives include:
Streamlining and improving the importation of prescription drugs from Canada under section 804 of the Federal Food, Drug, and Cosmetic Act;
Holding public listening sessions and issuing a report with recommendations to reduce anti-competitive behavior by pharmaceutical manufacturers;
Ensuring accuracy of Medicaid drug rebates consistent with Section 1927 of the Act;
Coordinating with FDA to develop recommended administrative and legislative changes to accelerate approval of generics, biosimilars and over-the-counter medications;
Providing recommendations on how to promote more competition, efficiency, transparency and value in the supply chain. The section title suggests that PBMs will remain in the spotlight; and
Proposing regulations consistent with the Employee Retirement Income Security Act of 1974 to improve PBM direct and indirect compensation transparency.
Key Takeaways:
Many of these directives and policy proposals will require legislation from Congress, as the Executive Order acknowledges. For example, the Executive Order has endorsed changes to the IRA—most notably it calls on Congress to pass legislation that would end the so-called “pill penalty,” which could restrict or delay Medicare’s ability to negotiate prices for small-molecule drugs if the time thresholds for small-molecule drugs are extended to match the timelines for negotiation of biologics.
Other directives and policy proposals in the Executive Order, however, may be enacted without the need for legislation from Congress. As a practical matter, implementing several of these proposals may be challenging in light of the reductions in force and structural changes implemented at HHS. As one example, and as noted above, the Executive Order aims to accelerate competition for high-cost prescription drugs and calls for “a report providing administrative and legislative recommendations to” accelerate approvals of generics, biosimilars and over-the-counter medications. However, accelerating approvals of generic and biosimilar products could be more difficult due to the elimination of the Division of Policy Development in the FDA’s Office of Generic Drug Policy.
This Executive Order marks the second major action taken by the current administration this month involving pharmaceuticals. We previously reported on new Section 232 Trade Investigations into the imports of pharmaceutical and pharmaceutical ingredients, and derivative products of those items, which could lead to trade actions related to imported pharmaceuticals.
The landscape in the pharmaceutical supply chain is changing at a breakneck pace. Actions taken pursuant to the Executive Order could result in significant changes to a number of policy issues related to the pharmaceutical and reimbursement spaces in the coming months and years. And it’s possible that many of these changes could lead to litigation.
[1] Under the IRA, the negotiated prices for the selected drugs that are covered under Medicare Part D will take effect in 2026, while negotiated prices for drugs covered under Medicare Part B are set to take effect in 2028.
Diagnosing Health Care: Breaking Down the Shifting Vaccine Policy Landscape [Podcast]
How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration’s federal health agency funding cuts?
On this episode, Epstein Becker Green attorneys Richard Hughes, Spreeha Choudhury, and Will Walters, as well as Anna Larson of EBG Advisors, discuss vaccine-related topics ranging from the measles outbreak and the reduction of the federal workforce to decreased government funding of public health programs.
Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations
As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is being transformed before our eyes. The journey ahead is anything but straightforward, with solutions ranging from bold, large-scale changes to more nuanced, focused innovations. Let’s delve into the high-level, dynamic trends shaping the pharmacy world today.
Medication Accessibility Challenges
Imagine living in a community where accessing essential medications has become a Herculean task. Increasingly, this is the reality for patients who live in areas hit hard by the closure of pharmacies. A study in Health Affairs found that more than 29% of the nearly 89,000 retail U.S. pharmacies that operated between 2010 and 2020 had closed by 2021, with the rate of closures increasing between 2018 and 2021 (during which time the number of pharmacies declined in 41 states).[1] That amounts to more than 26,000 store closures.[2] According to one of the study’s authors, Dima Qato, a University of Southern California pharmacy professor, closures are occurring at a higher rate at pharmacies that serve a greater percentage of Medicaid and Medicare patients.[3]
Closures have impacted stores owned by large chains as well as independent pharmacies. Store closures make it more difficult for patients to access to medications and to adhere to medication regimes, which puts patients at a greater risk, deepening health disparities. But there is hope. There are opportunities to enhance reliability for a mail-order pharmacy model and user-friendliness for remote pharmacy services. These have the potential to bridge existing gaps in healthcare access, ensuring patients conveniently and timely receive medications and expert guidance from pharmacists.
Shoring Up Supply Chains
At the same time as the number of pharmacies has decreased, pharmacies have faced challenges accessing product through the pharmaceutical supply chain. Drug shortages in the U.S. healthcare system are driven by several systemic and operational factors, including a vulnerable supply chain that relies heavily on foreign manufacturing of active pharmaceutical ingredients from countries like China and India.[4] This reliance exposes the supply chain to disruptions from geopolitical tensions, pandemics, and natural disasters.[5]
However, these challenges have highlighted opportunities for improvement and growth. Solving drug shortages will require policy innovation, strategic investments, and professional advocacy. Strengthening domestic production of active pharmaceutical ingredients can reduce reliance on foreign suppliers and enhance resilience. Legislative efforts, such as California’s CalRx initiative, focus on drug affordability by producing and distributing generic medications at low costs with transparent pricing, targeting markets lacking competition,[6] while federal proposals like the Affordable Drug Manufacturing Act advocate for government-backed production of essential generics.[7] Pharmacist advocacy is crucial, as they can engage with policymakers to highlight operational challenges and push for reforms like improved communication and streamlined FDA processes during shortages, creating a sustainable framework for drug manufacturing and encouraging fair pricing and access.[8]
Drug Price Transparency Reform
Drug price transparency is under renewed focus, with reforms aiming to increase clarity and reduce the control exerted by pharmacy benefit managers. President Trump’s Executive Order, issued on February 25, 2025, mandates agencies to enhance enforcement of existing health plan transparency regulations and to propose new guidelines for further standardizing and comparing pricing data.[9] The order provides a 90-day timeline for agencies to publish new policies, leaving the extent of change uncertain.[10] Despite this uncertainty, pharmacies have a significant role to play in driving these reforms. By emphasizing transparency in negotiated drug prices, pharmacies can foster more competitive dynamics and potentially improve rebate terms.[11]
Artificial Intelligence Caution
Artificial intelligence (AI) has the potential to revolutionize pharmacy by enhancing medication management, patient care, and healthcare efficiency. It can assist pharmacists in selecting drugs and dosages, identifying interactions, and reducing errors, while allowing personalized treatment plans based on patient data, which can improve outcomes and minimize adverse events.[12] AI also has the potential to streamline workflows by automating tasks like dispensing and inventory management, allowing pharmacists to focus on patient care, and can enhance communication through pharmacy applications offering 24/7 support.[13]
Despite its benefits, AI integration in pharmacy faces challenges such as high implementation costs, potential lack of empathy and personal touch that human pharmacists provide, and dependence on the quality of data inputs; incorrect or biased data can lead to flawed outcomes.[14] Ethical concerns like data privacy and informed consent are significant, as AI systems handle sensitive patient information.[15] Moreover, the need for substantial computing resources and technical expertise poses hurdles, particularly for smaller pharmacies.[16]
The pharmacy industry has opportunities to address these risks by investing in training to build trust and proficiency, collaborating with developers to ensure accuracy and to construct error protection measures, and to prioritize data privacy and ethical considerations.[17] By using AI to augment human expertise rather than replace it, pharmacies can maintain personal patient interactions while leveraging AI’s capabilities to enhance care.[18] Through collaborative efforts and innovative solutions, the pharmacy industry has possibilities to enhance health outcomes and access to care for all communities, paving the way for a healthier future.
FOOTNOTES
[1] Jenny S. Guadamuz et al., More US Pharmacies Closed Than Opened In 2018–21; Independent Pharmacies, Those In Black, Latinx Communities Most At Risk, 43 Health Affairs 1703 (2024); see Tom Murphy, Nearly 30% of US Drugstores Closed in One Decade, Study Shows, The Associated Press (Dec. 3, 2024, at 5:10 PM CDT), https://apnews.com/article/drugstore-closings-cvs-walgreens-independent-pharmacies-6b54d4bd1564b2bff7a55a624da61c19.
[2] See Murphy, supra note 1.
[3] See Guadamuz et al., supra note 1; Decline in Number of Pharmacies in Most States Since 2018, U.S. Pharmacist (Dec. 5, 2024), https://www.uspharmacist.com/article/decline-in-number-of-pharmacies-in-most-states-since-2018.
[4] See Joseph L. Fink & Kelli A. Boyden, Addressing Drug Shortages: A Call to Action for Pharmacists and Policymakers, 91 Pharmacy Times 38 (2025).
[5] Id.
[6] Fact Sheet: Making Prescription Drugs More Affordable For Californians, The State of California (updated Mar. 17, 2023), https://calrx.ca.gov/uploads/2023/03/CalRx-Fact-Sheet.pdf.
[7] Fink & Boyden, supra note 4.
[8] Id.
[9] Donald J. Trump, Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information, The White House (Feb. 25, 2025), https://www.whitehouse.gov/presidential-actions/2025/02/making-america-healthy-again-by-empowering-patients-with-clear-accurate-and-actionable-healthcare-pricing-information/.
[10] Id.
[11] See Ed Schoonveld, US Drug Price Negotiations and Transparency, Pharmaceutical Commerce, Pharmaceutical Commerce (Apr. 9, 2025), https://www.pharmaceuticalcommerce.com/view/us-drug-price-negotiations-and-transparency.
[12] See Rayn Oswalt, The Role of Artificial Intelligence in Pharmacy Practice, Pharmacy Times (Sept. 5, 2023), https://www.pharmacytimes.com/view/the-role-of-artificial-intelligence-in-pharmacy-practice; Osama Khan et al., The Future of Pharmacy: How AI is Revolutionizing the Industry, 1 Intelligent Pharmacy 32-40 (2023).
[13] Id.
[14] Id.
[15] Id.
[16] Id.
[17] Id.
[18] Id.
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State Antitrust Enforcement Roundup: New Laws; New Potential Legislation; and New (and Broader) Areas of Focus
The number of U.S. states implementing or considering new antitrust laws (or supplementing existing laws) targeting proposed transactions continues to grow. As detailed in our healthcare merger matrix, many states have focused their attention on the healthcare industry, and that continues to be the case, for example, in New York, where a broad range of proposed transactions involving health care entities could be subject to filing requirements and suspensory rules before they can close.
Moreover, and as detailed below, recently adopted laws and legislation under consideration in certain states are not limited to transactions involving healthcare providers or payors, nor are such developments limited to “blue” (politically more liberal) states, with Arkansas, Texas, Utah, and West Virginia, among others, undergoing or considering substantial expansions of their respective antitrust laws.
Arkansas Adopts Law Banning Pharmacy Benefit Managers from Owning Pharmacies
On April 16, 2025, Governor Sarah Huckabee Sanders signed HB 1150 into law, which will prohibit pharmacy benefit managers (“PBMs”) from owning pharmacies. This Arkansas law is the first of its kind and provides that a pharmacy benefits manager shall not acquire a direct or indirect interest in, or otherwise hold, directly or indirectly, a permit for the retail sale of drugs or medicines as of January 1, 2026.
California Considers Expansive New Antitrust Laws
In 2022, the California Law Review Commission (CLRC) was asked by the California Legislature to consider and recommend revisions to the state’s competition laws, i.e., the Cartwright Act. As a result of its review, the CLRC has recommended substantial revisions to the state’s antitrust regime.
The CLRC’s recommended changes cover the antitrust enforcement waterfront, from single firm conduct (monopolization and attempted monopolization) to concerted action. With respect to mergers, the CLRC found that California should adopt its own, independent merger control regime (today the state may only challenge deals under the federal Clayton Act). Most notably, the CLRC proposed that California become more aggressive when it comes to challenging proposed transactions by adopting a lesser standard to challenge deals than the federal standard, which requires the FTC or DOJ to provide that it is more likely than not that a deal would substantially lessen competition.
Washington State Enacts First-in-the-Nation General Premerger Notification Law; Colorado, D.C., Hawaii, Nevada, Utah, and West Virginia Considering Similar Legislation
The state of Washington became the first state to enact a state-level general premerger requirement. While many states have industry-specific notification laws (e.g., for health care mergers), this is the first general premerger notification requirement for a state. The law is modeled on the Uniform Antitrust Premerger Notification Act. Similar legislation is under consideration in California, Colorado, the District of Columbia, Hawaii, Nevada, Utah and West Virginia.
Starting July 27, 2025, any person that files a federal Hart-Scott-Rodino (“HSR”) filing must also submit contemporaneously a copy of the HSR form to the state if the person meets one of three criteria:
the person’s “principle place of business” is in Washington; or
the person (or a person it controls directly or indirectly) has annual net sales in Washington for the goods or services involved in the proposed transaction that are at least 20% of the Federal HSR size of transaction filing threshold (at present, 20% is $25,280,000); or
the person is a healthcare provider or provider organization in Washington (filing already required under Washington’s existing healthcare transaction law).
All required Washington filers must submit a copy of their federal HSR form to the state. Filers whose principle place of business is in Washington must also file the additional documentary material filed with an HSR form. Notably, the state may, upon request, require any filer to submit the additional documentary material, even if their principle place of business is not in Washington. There is no filing fee for the state filing and it does not trigger a suspensory waiting period. However, failure to file may result in a civil penalty of up to $10,000 per day of noncompliance.
* * * * *
We can now definitively say that the growing state-level interest in becoming active participants in the review process for transactions that impact their state is part of a long-term secular trend. Regardless of political bent, many states are no longer content to sit passively by while the FTC or DOJ make enforcement decisions that can have dramatic impacts at the state level. In the months and years that follow, we expect that more states will enact antitrust or antitrust adjacent laws that are independent of and potentially even more stringent than, the federal antitrust regime. These state regimes, once more of an afterthought, will require the full attention of parties considering transactions that may be captured by these new laws.
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This Week in 340B: April 15 – 21, 2025
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.
Issues at Stake: Rebate Model; Contract Pharmacy; Other
In six cases against HRSA related to rebate models:
In five cases, defendants filed a reply in further support of their motion for summary judgment.
In one case, the plaintiff filed a reply in support of its motion for summary judgment and in opposition to the government’s cross-motion for summary judgment.
In a case against Health Resources and Services Administration (HRSA) challenging its certification of a group of entities as 340B-eligible, defendants filed a memorandum of points and authorities in support of their partial motion to dismiss.
A trade association representing drug manufacturers filed a complaint to challenge a Utah state law restricting contract pharmacy arrangements.
In two appealed cases challenging a Louisiana law governing contract pharmacy arrangements, a group of amici filed amicus briefs.
Nadine Tejadilla contributed to this article.