China Releases Draft Implementation Measures for the Protection of Drug Trial Data Including Data Exclusivity for Foreign-Originated Drugs
On March 19, 2025, China’s National Medical Products Administration (NMPA) released Implementation Measures for the Protection of Drug Trial Data (Trial, Draft for Comments) (药品试验数据保护实施办法(试行，征求意见稿))and Working Procedures for the Protection of Drug Trial Data (Draft for Comments) (药品试验数据保护工作程序(征求意见稿)) that provides up to 6 years of data exclusivity of clinical trial data required to be submitted to the NMPA to prove safety and efficacy of a new drug to prevent generic drug manufacturers from relying on this data in their own applications. In contrast, the US generally provides 5 years of exclusivity. However, for foreign-originated drugs, the Chinese data protection period will be 6 years minus the time difference between the date on which the drug’s marketing authorization application in China is accepted and the date on which the drug first obtains marketing authorization overseas. Comments are due before May 18, 2025. The original documents as well as spreadsheets to submit comments are available here (Chinese only).
A translation of the Implementation Measures follows.
Article 1 (Purpose and Basis) These Measures are formulated in accordance with the Drug Administration Law of the People’s Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China, the Drug Registration Management Measures and other relevant regulations in order to encourage drug innovation and meet the public’s demand for medicines.
Article 2 (Management Mechanism) The State Drug Administration (hereinafter referred to as the NMPA ) is responsible for the protection of drug trial data (hereinafter referred to as data protection) and is responsible for establishing a data protection system and implementing management work in accordance with the principles of fairness, openness and impartiality.
The Drug Technical Review Center of the National Drug Administration (hereinafter referred to as the Drug Review Center) is responsible for the specific implementation of data protection.
Article 3 (Definition of Concepts) Data protection means that when drugs containing new chemical ingredients and other qualified drugs (see the attached table for details) are approved for marketing, the National Medical Products Administration shall protect the test data and other data submitted by the applicant that are obtained independently and not disclosed, and grant a data protection period of no more than 6 years.
During the data protection period, if other applicants apply for drug marketing authorization or supplementary application relying on the data in the preceding paragraph without the consent of the drug marketing authorization holder (hereinafter referred to as the holder), the National Medical Products Administration will not grant permission; unless other applicants obtain the data on their own.
During the data protection period, if other applicants submit drug registration applications using data obtained by themselves, their applications shall be approved if they meet the requirements and no longer be granted the data protection period, but the data shall not be relied upon by other subsequent applicants .
Article 4 (Conditions of protected data) Undisclosed trial data and other data refer to trial data in the complete application materials that are not disclosed in the application for drug marketing authorization for the first time in the country.
After a drug is approved, test data obtained when subsequent research work is completed in accordance with the requirements of the drug regulatory authorities will no longer be given new data protection.
Article 5 (Data Protection Related to Innovative Drugs) A six-year data protection period is granted for innovative drugs from the date of their first domestic marketing authorization.
If an original research drug that has been marketed overseas but not in China applies for marketing in China, the data protection period is 6 years minus the time difference between the date on which the drug’s marketing authorization application in China is accepted and the date on which the drug first obtains marketing authorization overseas. The data protection period is calculated from the date on which the drug obtains marketing authorization in China.
The scope of drug data protection in this clause includes all test data used in the drug marketing authorization application materials to prove the safety, efficacy and quality controllability of the drug.
For innovative drugs that have been approved for multiple indications but have the same approval number, each indication will be given data protection according to the registration category, and the scope of data protection for newly added indications will be the clinical trial data that support its marketing.
During the data protection period, the National Medical Products Administration will not approve the marketing application or supplementary application for improved new drugs, chemical generic drugs and biosimilar drugs submitted by other applicants without the consent of the holder, relying on the protected data of the holder , unless other applicants submit data obtained by themselves.
Article 6 (Protection of data related to improved new drugs) A three-year data protection period will be granted from the date of the first domestic marketing authorization for the improved new drug.
If a modified drug that has been marketed overseas but not in China applies for marketing in China, the data protection period is 3 years minus the time difference between the date on which the drug’s application for marketing authorization in China is accepted and the date on which the drug first obtains marketing authorization overseas. The data protection period is calculated from the date on which the drug obtains marketing authorization in China.
The scope of drug data protection in this clause includes new clinical trial data that demonstrates that the drug has significant clinical advantages over drugs with known active ingredients (marketed biological products), but does not include bioavailability, bioequivalence and immunogenicity data of vaccines.
During the data protection period, the National Medical Products Administration will not approve the marketing application or supplementary application for chemical generic drugs and biosimilar drugs submitted by other applicants without the holder’s consent and relying on the protected data of the holder , unless other applicants submit data obtained by themselves.
Article 7 (Data Protection Related to Generic Drugs) A three-year data protection period is granted to the first approved generic drugs (including drugs produced overseas) and biological products of original research drugs that have been marketed overseas but not in China. The data protection period is calculated from the date on which the generic drug or biological product obtains marketing authorization.
The scope of data protection for drugs in this clause includes necessary clinical trial data to support approval, but does not include bioavailability, bioequivalence and immunogenicity data of vaccines.
During the data protection period, the National Medical Products Administration will not approve the marketing application or supplementary application for chemical generic drugs and biosimilar drugs submitted by other applicants without the holder’s consent and relying on the protected data of the holder , unless other applicants submit data obtained by themselves.
Article 8 (Application and supporting documents) If the applicant intends to apply for data protection, he/she shall submit an application for data protection at the same time as submitting the application for drug marketing authorization. If there are any questions about data protection-related issues, he/she may apply for communication.
Article 9 (Technical Review) When conducting technical review of drug registration applications, the Center for Drug Evaluation shall confirm the scope and duration of data protection in accordance with the provisions of these Measures.
Article 10 (Granting of Protection Period and Publicity) For drugs that meet the data protection conditions, the National Medical Products Administration will mark the drug’s data protection information in the drug approval certificate.
The Center for Drug Evaluation has established a data protection column on its website to publish relevant information on drug data protection.
Article 11 (Acceptance, Review and Approval) After a drug obtains data protection, other applicants can submit drug marketing applications and supplementary applications that rely on the protected data within one year before the expiration of the data protection period . The Drug Evaluation Center will suspend the review time after completing the technical review, and the relevant drugs will be approved for marketing after the data protection period expires.
an applicant claims that the data was obtained independently when submitting a drug marketing application and a supplementary application , but it is discovered during the technical review process that the application relies on protected data of other applicants, the application will not be approved.
Article 12 (Termination of Data Protection) Data protection shall terminate if the drug approval document is revoked, suspended, or cancelled, if the holder voluntarily waives data protection, or in other circumstances prescribed by laws and regulations.
If data protection is terminated, the National Medical Products Administration will issue a notice on the termination of data protection, and the Drug Evaluation Center will update the relevant information in the data protection column based on the notice. From the date on which the National Medical Products Administration issues the notice on the termination of data protection, it can accept or approve drug registration applications submitted by other applicants that rely on the protected data.
Article 13 ( Incompliance with data protection information ) If, during the review process, it is found that the documents proving the first overseas marketing authorization for drugs submitted by the applicant in accordance with Articles 5 and 6 of these Measures do not match the actual situation , data protection will not be granted; if data protection has already been granted, the data protection will be cancelled.
Article 14 (Data Protection Procedure) The specific working procedures for data protection will be separately formulated by the Drug Evaluation Center.
Article 15 (Effective Date) This regulation shall come into force from now on.
Schedule 1
Chemical Drug Registration Classification and Data Protection Period
Classification
content
Data protection period
Category 1
Innovative drugs that have not been launched in the domestic or overseas markets.
6 years
Category 2
Improved new drugs that have not been marketed domestically or abroad.
3 years
Category 3
Domestic applicants copy original drugs that are marketed overseas but not in China.
3 years
Category 4
Domestic applicants copy original drugs that have been marketed domestically.
none
Category 5
Drugs that have been marketed overseas can apply for domestic marketing approval.
5.1
Original research drugs that have been marketed overseas apply for domestic marketing.
6 years – (domestic acceptance time – overseas listing time)
Improved drugs that have been marketed overseas may apply for domestic marketing approval.
3 years – (domestic acceptance time – overseas listing time)
5.2
Generic drugs that have been marketed overseas apply for domestic marketing.
3 years
Schedule 2
Registration classification and data protection period for preventive biological products
Classification
content
Data protection period
Category 1
Innovative vaccines
6 years
Category 2
Improved vaccines
3 years
Category 3
3.1 Application for listing of vaccines produced overseas and marketed overseas but not marketed domestically
6 years – (domestic acceptance time – overseas listing time)
3.2 Vaccines that have been marketed overseas but not in China can be produced and marketed in China
3 years
3.3 Vaccines already on the market in China
none
This Week in 340B: March 18 – 24, 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: Contract Pharmacy; Rebate Model
In a case by a drug manufacturer challenging a state law, the intervenor defendant filed a brief in support of its motion to compel discovery, and the drug manufacturer filed a brief in opposition to the intervenor’s motion for judgment on the pleadings.
In four cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models, the intervenor defendants filed a cross motion for summary judgment and opposition to the plaintiff’s motion for summary judgment.
In one such case, 37 state and regional hospital associates filed a motion for leave to file an amici brief in support of HRSA.
Ghost Guns and the Bankruptcy Code: Neither Provides Ammunition for Dismissing Actions – SCOTUS Today
The Supreme Court decided two cases today, continuing the release of opinions on which the Court is not deeply divided. The tougher ones are yet to come.
Despite the fact that today’s cases come from highly specialized areas of practice—firearms control and bankruptcy—both are interesting because they involve the interpretation of text, as Justices of all stripes continue to apply textual, literalist principles of interpretation rather than couching their views in a broader, arguably political, analysis of implied congressional intent.
The more closely watched of today’s two cases is Bondi v. Vanderstok, in which an interesting array of Justices—Justice Gorsuch wrote for himself and six other members of the Court (with Justices Thomas and Alito dissenting)—upheld a 2022 regulation of the Biden administration governing the sale and possession of so-called “ghost guns,” i.e., firearms made from kits constructed from untraceable parts. The regulation in question subjects the do-it-yourself “ghost gun” kits to the same requirements as fully assembled firearms, requiring serial numbers, background checks, and records of sales or transfers to private buyers. The Gorsuch opinion endorsed the position that the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) had the authority to issue the rule under the Gun Control Act of 1968 (GCA). The law “embraces, and thus permits ATF to regulate, some weapon parts kits and unfinished frames or receivers,” Gorsuch wrote. One notes that the Trump administration took no position in the case. The 7-2 decision keeps in force the 2022 regulation. Justice Gorsuch’s leadership as to the decision—a rare reversal of the U.S. Court of Appeals for the Fifth Circuit—is particularly interesting because of his alignment with three conservatives (Chief Justice Roberts, the increasingly independent Justice Barrett, and Justice Kavanaugh) and the Court’s three liberals.
Turning to the stated language of the GCA, Justice Gorsuch writes that the GCA authorizes ATF to regulate “any weapon . . . which will or is designed to or may readily be converted to expel a projectile by the action of an explosive.” This language creates two requirements. First, there must be a “weapon.” Second, the weapon “must be able to expel a projectile by the action of an explosive, designed to do so, or susceptible of ready conversion to operate that way.” According to the Court, “[A]t least some kits will satisfy both.” Rejecting the application of the rule of lenity and the rule of constitutional avoidance, Justice Gorsuch held that neither of those rules “has any role to play where ‘text, context, and structure’ decide the case. . . . The GCA embraces, and thus permits ATF to regulate, some weapons parts kits and unfinished frames or receivers, including those we have discussed. Because the court of appeals held otherwise, its judgment is reversed, and the case is remanded for further proceedings consistent with this opinion.”
Justice Thomas dissented, arguing that the statutory terms did not cover the unfinished frames in the parts kits and that those kits, by themselves, did not fit the definition of a “firearm.” Justice Alito argued that the majority decided the case on grounds that were not raised or decided in the courts below. Both dissents are swamped by the strong bipartisan majority that, as Justice Gorsuch made clear, was conscious of the regulation’s origin in the wake of the assassination of Dr. Martin Luther King, Jr.
From a Court “politics” standpoint, the other case decided today, United States v. Miller, is just as interesting. In this case, Justice Jackson’s majority opinion was joined by all of the other Justices, save for Justice Gorsuch, who dissented. The case involved the power of a bankruptcy trustee under the Bankruptcy Code, 11 U.S.C. §544(b)(1), to set aside, or “avoid,” certain fraudulent transfers of a debtor’s assets. The Court held that the Bankruptcy Code’s waiver of sovereign immunity only waives sovereign immunity with respect to the federal cause of action created by Section 544(b), which gives the trustee the power to avoid certain transfers that would be “voidable under applicable law”—that is, voidable outside of bankruptcy proceedings. However, it doesn’t encompass sovereign immunity for state law claims nested within that federal claim. Ultimately, the case is remanded to allow the courts below to consider an argument based on state law that was not briefed or considered by the Supreme Court.
Again, we note that the Court continues to deal with the “easy” stuff. There remain more than a few storm clouds on the horizon. So, keep your rubber boots on and look out for lightning in the days to come.
DEA Buprenorphine Rule Delayed to December 31, 2025
The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final buprenorphine rule) to December 31, 2025. In its final rule postponing the effective date, the DEA notes that it received 32 comments. Of those, 13 commenters requested the effective date be finalized as soon as possible, while three urged an additional delay. Eleven commenters raised concerns about the final buprenorphine rule itself. The DEA states that, because of these comments, it will further delay the effective date to further review any questions of fact, law, and policy the rules may raise.
A Brief History
On January 17, 2025, in anticipation of the change of administration, the DEA and HHS finalized and published the final buprenorphine rule, which establishes a permanent pathway for the telemedicine prescribing of buprenorphine for opioid use disorder (OUD). The final buprenorphine rule was set to take effect February 18, 2025. (See our prior blog “DEA Tightens Buprenorphine Telemedicine Prescribing Rules” which discusses the requirements of the final buprenorphine rule.) On January 20, 2025, the Trump administration issued the Regulatory Freeze Pending Review Presidential Memorandum authorizing HHS and the DEA to delay the effective date of the final buprenorphine rule until March 21, 2025. The delay was intended to allow time to review any questions of fact, law, and policy the rule may raise, as well as to open a comment period to gather input from interested parties. On February 14, 2025, in accordance with the Presidential Memorandum, HHS and the DEA announced this delay and review of the final buprenorphine rule. (See our prior blog “DEA Delays Final Buprenorphine Rule” about the first delayed effective date of the final buprenorphine rule.)
Make Your Voice Heard
HHS and the DEA are not accepting formal comments with this final rule. However, stakeholders with concerns about the final buprenorphine rule and its effective date are encouraged to share their feedback by contacting their local Congressperson or the White House.
What Comes Next
With the delay of the final buprenorphine rule, stakeholders can continue relying on the current set of telemedicine prescribing flexibilities through the end of 2025 without uncertainty about whether the obligations of the final buprenorphine final rule will apply and potentially supersede the flexibilities now that the dates are aligned. As a potential permanent solution for prescribing OUD treatment via telemedicine, two U.S. Senators reintroduced the Telehealth Response for E-Prescribing Addiction Therapy Services (TREATS) Act in March 2025, as bipartisan legislation. The TREATS Act amends the Controlled Substances Act to make the buprenorphine-related telemedicine prescribing flexibilities permanent. It was previously introduced in June 2020, February 2021, and November 2023, but in each instance, it did not progress out of Committee.
Although the TREATS Act is more favorable to stakeholders than the final buprenorphine rule because it does not include the additional obligations of the final buprenorphine rule, its history suggests it is unlikely to be signed into law. However, because the current DEA stance on the issue is still unclear, there remains a possibility that the TREATS Act could be finalized in place of the final buprenorphine rule. We will continue to monitor developments regarding the final buprenorphine rule and the TREATS Act.
Telehealth Cliff Averted, for Now (But September is Six Months Away)
The potential plunge off the telehealth cliff that we warned you about in our March 3, 2025, blog post has been averted, for now.
With the passage of the Continuing Resolution (CR) by the House and Senate, and the subsequent signing by the president, current telehealth flexibilities and Medicare coverage for the benefit will not expire on March 31. With funding established through the end of the fiscal year—September 30, 2025—the CR provides at least a brief extension of telehealth flexibilities for those, particularly in rural areas or with mobility problems, who have come to rely on telehealth for access to critical health care services since March 2020.
As we noted on March 3, COVID-19 shifted perceptions of telehealth in a way that is not likely to ever return to pre-2020 notions, despite the wrangling over extensions. Between April and June of 2020, nearly half of all Medicare beneficiaries had at least one virtual medical visit. The COVID-19 public health emergency officially ended in May 2023, but the Medicare telehealth flexibilities have been extended several times.
The Continuing Resolution: Telehealth
Section 2207 of the CR, “Extension of Certain Telehealth Flexibilities,” is substantively identical to Section 3207 of the American Relief Act of 2025 (which granted the 90-day extension for telehealth flexibilities through March 2025). The new Section 2207, with the September 30 date,
Removes geographic requirements and expands originating sites for telehealth services (including patients’ homes);
Expands the list of practitioners who are eligible to furnish telehealth services (includes all practitioners who are eligible to bill Medicare for covered services, such as physical and occupational therapists, speech pathologists, audiologists, marriage and family therapists, and mental health services);
Extends telehealth services to federally qualified health centers (FQHCs) and rural health clinics (RHCs), who may serve as distant site providers;
Delays the Medicare in-person requirements for mental health services furnished through telehealth and telecommunications technology, including FQHCs and RHCs;
Allows for the payment/furnishing of audio-only telehealth services;
Extending use of telehealth to conduct face-to-face encounter(s) prior to recertification of eligibility for hospice care; and
Granting program instruction authority, meaning that the secretary of the Department of Health and Human Services may implement the amendments made by this section through program instruction or otherwise.
Utilization and Costs
Immediately following the passage and signing of the CR, the Center for Connected Health Policy and the National Telehealth Policy Resource Center issued an article pointing out that recent Medicare utilization and spending findings actually support Medicare telehealth expansions—and do not in fact support discontinuing the extensions on the grounds of increased patient utilization or costs.
As these organizations noted, the University of Michigan’s Institute for Healthcare Policy and Innovation has concluded—with respect to outpatient utilization—that while mental health is a high driver of telehealth use, and primary care is a moderate one, telehealth did not cause a rise in total post-pandemic evaluation and management visits among Medicare fee-for-service beneficiaries when compared to prepandemic levels (orthopedic surgery, for example, has low telehealth use).
A second study by the Institute for Healthcare Policy and Innovation similarly lends support for permanent telehealth coverage when examining the question of costs. This study found that telehealth-initiated visits were actually associated with lower 30-day spending compared to in-person-initiated visits. Though return visit rates were higher for telehealth, lab testing and imaging rates were lower, suggesting that telehealth may reduce overall Medicare spending.
The Next Six Months?
The American Telemedicine Association and its advocacy arm, ATA Action, have called the March 14 vote on the CR “a big victory for telehealth, and a huge relief for patients and clinicians in every state and region of the United States, especially those in underserved communities.” Yet Kyle Zebley, ATA Action’s executive director, called the short extensions “an impediment to long-term certainty.”
Certain provisions that were left out of the year-end funding package of December 2024 remain excluded, such as
First dollar coverage of High Deductible Health Plans/Health Savings Accounts (HDHP-HSA) tax provision;
In-home cardiology rehabilitation flexibilities;
Virtual diabetes prevention program suppliers in Medicare Diabetes Prevention Program (MDPP); and
SPEAK Act which facilitates guidance and access to best practices on providing telehealth services accessibly.
Some organizations, such as the National Consortium of Telehealth Resource Centers, are already preparing for the next telehealth policy cliff on October 1, 2025. For now, as the Telehealth Policy website of the Department of Health and Human Services states, telehealth services can still be provided by all eligible Medicare providers through September 30, 2025. Until that date:
There are no geographic restrictions for originating sites for Medicare telehealth services, and Medicare patients can receive these services in their home.
An in-person visit within six months of an initial Medicare behavioral/mental telehealth service, and annually thereafter, is not required.
FQHCs and RHCs can serve as Medicare distant site providers for nonbehavioral/mental telehealth services.
Telehealth services in Medicare can be delivered using audio-only communication.
The End of the Self-Affirmed GRAS Pathway?
On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential rulemaking” to eliminate the pathway allowing companies to self-affirm that food ingredients are Generally Recognized as Safe (“GRAS”).
This means that companies seeking to introduce new food ingredients would be required to publicly notify the FDA of the ingredients’ intended use and underlying safety data. Presently, the FDA strongly encourages but does not require the submission of a GRAS notice. Given the importance of the issue, the food industry should closely monitor any change to the FDA’s regulation of GRAS ingredients.
Defining GRAS
Under the Federal Food, Drug, and Cosmetic Act, unless a substance is generally recognized among qualified experts as safe under the conditions of its intended use, food additives are subject to premarket review and approval by the FDA. The implementing regulations, 21 C.F.R. §§ 170.3 and 170.30, provide that the use of a food substance can be GRAS through scientific procedures or experience based on common use in food before 1958. Salt, pepper, vinegar, baking powder, and monosodium glutamate are some examples.
GRAS Pathways and FDA Procedures
Currently, manufacturers may determine a food ingredient is GRAS through one of two pathways: self-affirmation, or notification to the FDA by submission of a GRAS notice. But if the voluntary FDA notification pathway becomes mandatory through legislation or rulemaking, companies using the self-affirmation process would be well-served to familiarize themselves with current FDA GRAS procedures.
As mentioned above, 21 C.F.R. § 170.30 sets forth the eligibility for classification of a substance as GRAS.
Under 21 C.F.R. § 170.35, the Commissioner may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use. If so, the Commissioner will publish a notice in the Federal Register and evaluate comments received following a 60-day comment period.
If there is convincing evidence that the substance is GRAS, the Commissioner will publish a notice listing the GRAS conditions of use.
If there is a lack of convincing evidence and the substance should instead be considered a food additive, the Commissioner shall publish a notice in accordance with 21 C.F.R. § 170.38.
In 2016, the FDA issued the final rule at issue, 81 Fed. Reg. 54960 (Aug. 17, 2016), that formalized the voluntary GRAS notification program. 21 C.F.R. Part 170, Subpart E provides the process for submission of a GRAS notice, including how to send a GRAS notice to the FDA, general requirements of a GRAS notice, the seven required parts of a GRAS notice, the FDA’s evaluation and response, and public disclosure of a GRAS notice. According to the HHS, the FDA evaluates 75 GRAS notices per year and has published over 1,000 notices, which are available in a public inventory.
Takeaways
In the HHS release, Secretary Kennedy commented, “For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.” His proposal for addressing the “loophole” may involve more than rulemaking—the release also states that the HHS “is committed to working with Congress to explore ways legislation can completely close the GRAS loophole.” In the meantime, companies should familiarize themselves with FDA GRAS procedures.
Ex officio interventions by the Anti-Corruption and Good Government Ministry in public tenders in México
As part of the verification powers of the Anti-Corruption and Good Government Ministry in the bidding and contracting processes of the Public Sector, the Law on Acquisitions, Leases, and Services of the Public Sector allows it to carry out ex officio interventions to review the legality of public tender procedures.
As part of this function and in response to complaints filed by some pharmaceutical companies regarding the possible commission of acts of corruption, mainly related to the price offered for medicines, the aforementioned Ministry is carrying out an ex officio intervention to the convening authority called Laboratorios de Biológicos y Reactivos de México (BIRMEX) of the procedure of the open international public tender for the consolidated acquisition of medicines, therapeutic goods, healing material and diagnostic aids for fiscal years 2025 and 2026 in order to detect possible irregularities, and as part of said procedure, the entities who were awarded are being required to appear as third interested parties to make statements and to be able to provide information they consider relevant regarding the aforementioned tender process.
These ex officio interventions are not common, and the authorities are carrying them out with greater emphasis to supervise and document the bidding process, and if necessary, they could cancel purchases related to the codes that have not complied with the rules of the process.
DEA Telemedicine Rules Further Delayed Until (Nearly) 2026
Those waiting anxiously for the rules expanding the prescribing of buprenorphine via telemedicine and the controlled substance prescribing for patients at the Department of Veterans Affairs to officially go into effect will now have to wait until New Year’s Eve—December 31, 2025.
Practitioners will, however, be allowed to continue prescribing via telemedicine without first having an in-person visit with the patient, owing to COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, in effect through the same end-of-year date.
A seven-page document released by the Department of Justice’s Drug Enforcement Administration (DOJ, DEA) and Department of Health and Human Services (HHS)—scheduled to be published in the Federal Register on March 24—further delays the effective dates of the “Expansion of Buprenorphine Treatment via Telemedicine Encounter” Final Rule and the “Continuity of Care for Veterans Affairs Patients” Final Rule, both dated January 17, 2025 .
As we alerted you in February, these same two rules, collectively referred to as the “Buprenorphine and VA Telemedicine Prescribing Rules,” were originally scheduled to become final on February 18, 2025 but were delayed until March 21, 2025.
The first delay stemmed from the January 20, 2025, Presidential Memorandum titled “Regulatory Freeze Pending Review” (the “Freeze Memo”) that empowered federal departments and agencies to “consider postponing” the dates of rules published but not yet in effect.
After reviewing the 32 comments that the first delay generated, the DOJ now “wishes to further postpone the effective dates for the purpose of further reviewing any questions of fact, law, and policy that the rules may raise,” despite the fact that 13 of the 32 commenters wished to finalize the effective date of the two rules as soon as possible.
The Rules
The Buprenorphine and VA Telemedicine Prescribing Rules amended previous regulations to expand the circumstances under which:
practitioners registered by DEA are authorized to prescribe schedule III-V controlled substances approved by the FDA for treatment of opioid use disorder via a telemedicine encounter; and
VA practitioners acting within the scope of their VA employment are authorized to prescribe schedule II-IV controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation, if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to conditions.
The EBG team continues to monitor any changes to the Buprenorphine and VA Telemedicine Prescribing Rules.
Additional Author: David Shillcutt
The Ketamine Administration Market: A Legal Guide for Healthcare Entities
Ketamine is rapidly gaining attention as a legitimate treatment for depression, PTSD, and chronic pain. While traditionally used as an anesthetic, its off-label therapeutic benefits have driven significant growth in ketamine infusion clinics and home-treatment models. This has created an exciting but complex opportunity for healthcare entities eager to expand into the market.
Key Considerations for Entering the Market
Before establishing a ketamine administration service, it’s crucial to understand the regulatory landscape. Ketamine is classified as a Schedule III controlled substance, meaning there are strict federal and state rules regarding its prescribing, storage, and administration. Healthcare providers must register with the Drug Enforcement Administration (DEA) and adhere closely to rules surrounding controlled substances. Additionally, federal telehealth regulations—which significantly impact home-based ketamine therapies—are evolving, meaning businesses must stay informed about changing compliance requirements.
In New York and similarly regulated states, only licensed healthcare professionals, typically physicians, can own or operate medical practices administering ketamine. Non-physician entrepreneurs must navigate carefully structured arrangements, like Management Services Organizations (MSOs), to legally participate in the business side without violating state regulations. It’s also critical to recognize that, beyond federal regulations, state laws and requirements can vary widely. Healthcare entities planning to operate across state lines must ensure compliance with each individual state’s rules.
Risks and Liabilities
Entering the ketamine treatment field brings significant responsibilities. Safety and patient oversight are primary concerns, especially given the drug’s potential side effects. Whether treatments are administered in-clinic or at-home, appropriate medical supervision and thorough patient monitoring are essential to protect patient health and mitigate legal risks. Moreover, improper handling or prescribing of ketamine can lead to serious regulatory penalties or malpractice claims. Ensuring strict adherence to patient screening, informed consent practices, secure drug storage, and detailed record-keeping is fundamental. Providers must also consider robust emergency protocols specifically tailored for ketamine administration.
Federal Circuit Decision Could Encourage More Reissue Patents
The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S. Food and Drug Administration (FDA). The length of a PTE award depends on how much time was spent under FDA review after the patent was issued. But which issue date is used for a reissued patent? In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., the Federal Circuit decided that the earlier issue date of the original patent should be used to calculate PTE. By essentially preserving PTE awarded to original patents, this decision could encourage pharmaceutical companies to pursue reissue, especially if there are any concerns that broad original claims may not comply with the court’s recent Orange Book listing guidance.
The BRIDION® Patent And Regulatory Review Period at Issue
The patent at issue is listed in the Orange Book for Merck’s BRIDION® (sugammadex) product, which is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. The patent was first issued December 30, 2003, as U.S. Patent No. 6,670,340, and then reissued on January 28, 2014, as U.S. Patent No. RE44,733. The reissued patent amended a dependent claim to expressly recite the active ingredient of BRIDION®.
Merck applied for FDA approval of sugammadex on April 13, 2004 (four months after the ’340 patent issued), and it was approved on December 15, 2015. Thereafter, Merck sought, and the USPTO granted, the maximum five years of PTE available under § 156, using the issue date of the original ’340 patent for the PTE calculation. (If the issue date of U.S. Patent No. RE44,733 had been used, the PTE award would have been only 686 days.)
The challenge to the PTE award arose in the context of ANDA litigation brought by several companies seeking FDA approval to sell generic versions of BRIDION®. The district court agreed with the USPTO’s calculation, and on appeal the Federal Circuit did too.
The Federal Circuit Opinion
The Federal Circuit opinion was authored by Judge Dyk and joined by Judges Mayer and Reyna. As framed in the opinion, the issue on appeal was one of statutory construction—the meaning of “the patent” in §156(c):
The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued …
The Federal Circuit agreed with the USPTO that the language of §156(c) itself was ambiguous in that it is “unclear whether ‘the patent’ refers to the original or reissued patent.” Thus, the Federal Circuit considered “the broader context of the statute as a whole,” stating:
[T]he purpose of [§ 156] is clear: to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications.
With this purpose in mind, the opinion reasons:
That purpose applies in this case, since construing “the patent” in subsection 156(c) as the original patent compensates Merck for the period of exclusivity lost due to regulatory delay. On the other hand, Aurobindo’s construction denies Merck compensation for all but a small period of the delay. There is no reason why the Hatch-Waxman Act’s purpose would be served by disabling extensions of the unexpired term solely based on a patent holder’s decision to seek reissue …
The opinion concludes:
We thus conclude that, in the context of reissued patents, “the patent” in subsection 156(c) refers to the original patent. A reissued patent is entitled to PTE based on the original patent’s issue date where, as here, the original patent included the same claims directed to a drug product subject to FDA review.
Reissue Patents and Orange Book Listings
As discussed in this article, the Federal Circuit decision in Teva v. Amneal may have patent owners taking a second look at their Orange Book-listed patents, to assess whether they “particularly point out and distinctly claim” the specific drug approved by the FDA. For patents that disclose but do not expressly claim the approved active ingredient, seeking a reissue patent could allay Orange Book listability concerns. The PTE decision in Merck indicates that obtaining a reissued patent would not lessen PTE, providing further reason to consider the reissue process as an opportunity to strengthen a patent portfolio.
What Vice Chancellor Strine Got Wrong In Massey Energy Co.
Vice Chancellor Leo Strine famously wrote that “Delaware law does not charter law breakers”. In re Massey Energy Co., 2011 WL 2176479, at *20 (Del. Ch. May 31, 2011). Professor William J. Moon picks up on this theme in a forthcoming essay, Havens for Corporate Lawbreaking:
Yet even the fiercest defenders of the firm’s profit motive concede that the corporation’s profit-seeking function cannot justify breaking the law. As a matter of American corporate law, directors and officers are in breach of their fiduciary duties if they facilitate or engage in profit-maximizing illegal activities. Or so we thought.
Professor Moon’s essay calls out Nevada and the Cayman Islands as “corporate lawbreaking havens”. But are Vice Chancellor Strine and Professor Moon correct that Delaware does not charter corporate lawbreakers? I think not.
In JCCrandall, LLC v. Cnty. of Santa Barbara, 328 Cal. Rptr. 3d 828, 831 (Ct. App. 2025), review denied and ordered not to be officially published (Mar. 19, 2025), a California Court of Appeal pointed out the cannabis is illegal:
It is often said that cannabis is legal in California. The statement is not true. Under federal law, cannabis is illegal in every state and territory of the United States. (See Controlled Substances Act, 21 U.S.C. § 801 et seq.; 21 U.S.C. § 812 (c)(10); City of Garden Grove v. Superior Court (2007) 157 Cal.App.4th 355, 377, 68 Cal.Rptr.3d 656.) Article VI, paragraph 2 of the United States Constitution, known as the Supremacy Clause, provides in part, “The Constitution, and the Laws of the United States . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.”
Therefore, any Delaware corporation engaged in the cannabis trade is potentially violating the law. Are the directors and officers of these corporation breaching their fiduciary duties when they allow the corporation to engage in the business for which it was formed?
It might be argued that Vice Chancellor Strine was referring only to Delaware law, but the Massey case involved violations of federal law. Thus, it cannot be said that he was referring only to state laws. Does this mean that Delaware charters the breakers of some laws? If so, how do directors and officers know which violations will support a breach of fiduciary duty claim and which will not?
More fundamentally, the immensity and complexity of state and federal laws and regulations mean that it impossible for most corporations to comply fully with all laws and regulations. Therefore, Delaware does indeed charter law breakers. This is most certainly true.
West Virginia Set to Ban Certain Food Additives and Colors
On March 19, 2025, the West Virginia Senate and House sent HB 2354 to the governor for final approval, which proposes banning various food additives and synthetic dyes.
The bill would prohibit the sale of any food product in the state that contains butylated hydroxyanisole (BHA), propylparaben, Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, or Green No. 3. If enacted, the legislation would apply to food products in school nutrition programs beginning August 1, 2025, then extend to all food products in the state on January 1, 2028.
While there was some push back arguing that the state should wait for changes to come top down from the U.S. Food and Drug Administration (FDA) and that the ban will cause food prices to go up or limit the competitiveness of the state, the voting pattern shows that the opposition was minimal. This article by West Virginia Watch stated that Senator Barrett, who spearheaded the effort, feels confident that the Governor will sign HB 2354.
The West Virginia bill is the latest state legislative effort to regulate food dyes, following California, Utah, Florida, and Virginia.