GLP-1 Receptor Agonists: Drug Litigation Overview and Trends
The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide range of issues including patent and other IP disputes, product liability, regulatory challenges, importation concerns, and legal issues concerning the availability of compounded versions of GLP-1 drugs in view of the U.S. Food & Drug Administration (FDA)-declared drug shortages.
Compounded Drugs and FDA-Declared Drug Shortages
Due to the increased popularity of GLP-1 drugs for treatment of diabetes and for weight management, many of the FDA-approved drugs have experienced drug shortages over the past few years. In contrast to the FDA-approved GLP-1 drugs, compounded drugs are typically created by licensed pharmacists for individual patient needs and are not subject to the same rigorous FDA review process for safety and efficacy. Entities may only sell compounded drugs that are identical to an FDA-approved drug when that drug is on the FDA drug shortage list. Although compounded drugs may be legally sold during a declared drug shortage, the compounded drugs must still comply with certain other legal and regulatory requirements directed to quality and safety issues.
Finding an inability of brand name GLP-1 manufacturers to keep up with patient demand for approved GLP-1 drugs, the FDA temporarily placed many of the approved GLP-1 drugs on the FDA shortage list, leading to an increase in the availability and sale of compounded drugs containing the active ingredient. This in turn led to significant litigation between brand name GLP-1 manufacturers and groups representing entities selling compounded drugs.
For example, brand name GLP-1 manufacturers have filed numerous lawsuits against entities manufacturing and selling compounded versions of their drugs, alleging a wide range of claims including failure to comply with regulatory requirements, trademark infringement, violation of consumer protection laws, and various allegations directed to mispresenting and deceiving patients as to the regulatory status of the compounded versions.
As brand name manufacturing capacity has increased to meet patient demand, the FDA has removed some of the GLP-1 drugs from the drug shortage list, leading to lawsuits filed by the compounding pharmacies against FDA. For example, FDA removed tirzepatide from the drug shortage list in October 2024. In response, Outsourcing Facilities Association filed a lawsuit against FDA in the Northern District of Texas on behalf of its members, challenging FDA’s decision to remove the drug from the drug shortage list as arbitrary and capricious. The matter was remanded back to FDA for reconsideration, and FDA issued a decision in December 2024 confirming the drug shortage was resolved. Most recently, in March 2025, the district court denied the plaintiff’s motion for a preliminary injunction, finding FDA’s decision to remove tirzepatide from the drug shortage list was proper. That case is now on appeal.
A similar round of lawsuits was filed in 2025 following FDA’s decision to remove semaglutide products from the drug shortage list.
Given the ongoing popularity and high demand for GLP-1 drugs in the U.S., we expect both sides to continue litigating over these issues.
Patent Litigation
To date, patent infringement lawsuits have largely followed the framework under the Hatch-Waxman Act applicable to generic drug manufacturers who seek FDA approval to market generic versions of approved drugs (“reference listed drugs”) by filing Abbreviated New Drug Applications (ANDAs). The ability to even file an ANDA is subject to applicable FDA exclusivity periods. One of the relevant exclusivity periods applies to New Drug Applications (NDA) for approved products containing new chemical entities (NCEs), whereby an ANDA with a paragraph IV certification may not be submitted until four years after the NDA was approved (i.e., the NCE-1 date). Another relevant exclusivity period applies when a previously approved drug is approved for a new patient population based on new clinical studies–any ANDAs directed to that new patient population (NPP) may not be approved for a period of three years.
Because the filing and/or approval of ANDAs is tied to the FDA exclusivity periods granted to the reference listed GLP-1 drugs, the timing of related patent infringement lawsuits brought under the Hatch-Waxman Act varies as well.
For example, liraglutide was first approved in 2010 as Victoza® for treatment of diabetes and later approved in 2014 as Saxenda® for weight loss. All relevant FDA exclusivity periods for liraglutide have expired, with patent litigation against potential generic competitors starting in 2017. FDA approved the first generic drug containing liraglutide in December 2024.
As another example, semaglutide was first approved in 2017 as Ozempic® for treatment of diabetes and later approved in 2021 as Wegovy® for weight management and weight loss. The NCE period for semaglutide has expired permitting the filing of ANDAs, although the three-year NPP exclusivity is still active for Wegovy® through December 2025. Patent litigation has been initiated against at least nine generic competitors, with settlements reported in connection with the first wave of lawsuits filed in 2022. New lawsuits were filed in 2024 against additional generic competitors, which remain ongoing. FDA has not yet approved any generic versions of semaglutide, and it is unclear when any such approved generic drugs may be permitted to enter the U.S. market.
The newest GLP-1 drug, tirzepatide, was first approved in 2022 as Mounjaro® for treatment of diabetes and later approved in 2024 as Zepbound® for obesity. The NCE period for tirzepatide runs through May 13, 2027, which means generic companies may not file an ANDA seeking approval for a generic version of Mounjaro® or Zepbound® until May 13, 2026, with patent infringement lawsuits expected to occur in the following months.
Two additional areas that may be ripe for future patent-related litigation challenges involving GLP-1 drugs include patent infringement claims brought against compounding pharmacies and claims challenging whether patents are properly listed in the Orange Book for certain GLP-1 drugs.
To date, name brand manufacturers of FDA-approved GLP-1 drugs have not appeared to target compounding pharmacies with patent infringement lawsuits, choosing instead to litigate other claims against these entities, as discussed in more detail above. As those litigations wrap up, it is possible that we could see additional patent infringement claims brought against entities making and selling compounded versions of the drugs.
Starting in fall of 2023, the Federal Trade Commission (FTC) announced a new policy expressing concerns over the potential anticompetitive effect of patents that may have been improperly listed in the Orange Book. The FTC followed this announcement with several rounds of letters to name brand manufacturers (including GLP-1 manufacturers), notifying them of FTC’s claim that certain patents were improperly or inaccurately listed. Similar challenges have been raised in U.S. courts (although directed to other drug classes), with the Federal Circuit reaching a decision in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. LLC in December 2025. In that case, Amneal filed a counterclaim seeking an order to delist certain device patents from the Orange Book. The Federal Circuit affirmed the district court’s delisting order, finding the device patents were not properly listable because they did not claim a specific active ingredient and instead were only directed to components of the device. Although there are a range of different patents listed in the Orange Book for GLP-1 drugs, it is worth monitoring ongoing FTC investigations and enforcement trends to the extent these may impact future Orange Book listing challenges raised by competitors.
International Trade Commission
Section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337) grants the U.S. International Trade Commission (ITC) authority to resolve complaints filed by companies alleging unfair acts in the importation of products into the U.S. Although Section 337 cases typically involve allegations of infringement of various IP rights, including patents, trade secrets and trademarks, the ITC is also empowered to address other violations, including claims based on importation of non-approved drugs and Lanham Act claims based on false advertising and false designation of origin.
In addition to moving more quickly relative to most U.S. district court litigations, ITC cases involve several unique aspects, including a domestic industry requirement whereby the complainant asserting the violation must prove that it has established (or is in the process of establishing) a domestic industry that practices the IP right through a significant investment in various activities, including plant, equipment, labor, capital and/or a substantial investment in research and development or licensing. The remedies that may be awarded for a violation are extremely effective and can include either a limited or general exclusion order, enforced by U.S. Customs and Border Protection, which effectively bar the importation of products in violation of Section 337 from entering the U.S. Limited exclusion orders are limited to only the subject articles imported by named respondents, whereas general exclusion orders are more difficult to obtain and apply generally to all subject articles, regardless of who is responsible for importation. If proven, a general exclusion order can be extremely valuable to companies who are facing competition through importation of infringing or counterfeit articles from multiple entities where the responsible party is difficult to identify or routinely changes names/addresses.
At least one approved GLP-1 manufacturer (Eli Lilly) has filed a complaint with the ITC against various online pharmacies selling compounded drugs containing tirzepatide. Eli Lilly’s claims against the online pharmacies allege importation of unapproved drug products containing tirzepatide along with misuse of the Mounjaro® trademark and false and misleading statements regarding FDA approval and equivalency to the approval Mounjaro® product. In December 2024, the Administrative Law Judge (ALJ) at the ITC issued an Initial Determination partially granting summary determination against several of the accused pharmacies on the trademark, false designation and false advertising claims. In that decision, the ALJ also recommended the ITC issue a general exclusion order banning the importation of all products containing tirzepatide. In January 2025, the ITC issued a notice stating it was not going to review the summary determination order but sought further comments on public interest and remedy. A final decision on remedy is expected in April 2025.
Future Litigation Trends
Just as the U.S. market has adapted to the increase in sales of approved GLP-1 drugs, leading to FDA-declared drug shortages and the availability of compounded versions, the litigation landscape has adjusted as well with recent decisions focusing on FDA’s decision to remove these drugs from the shortage list. Likewise, patent litigation involving GLP-1 drugs is expected to evolve as FDA exclusivity periods expire in the near future, leading to additional challenges raised by potential generic drug competitors. Given the popularity of these drugs, relevant players in the market have adapted their litigation strategies to raise new legal claims, including in additional forums with significant remedies for violation of various IP rights.
USDA Will Fund 543 Projects in 29 States Through Higher Blends Infrastructure Incentive Program
On March 31, 2025, the U.S. Department of Agriculture (USDA) announced that it will release obligated funding under the Higher Blends Infrastructure Incentive Program (HBIIP) for 543 projects totaling $537 million in 29 states. According to the press release, USDA is “aggressively exploring additional ways to unleash American energy and incentivize the production and use of homegrown U.S. biofuels, including working alongside the Environmental Protection Agency (EPA) to develop Renewable Volume Obligations (RVO) that support the biofuel industry, as well as supporting EPA’s review of any potential emergency fuel waivers to allow the nationwide year-round sale of E15.” USDA provides HBIIP grants to fueling station and distribution facility owners, including marine, rail, and home heating oil facilities, to help expand access to domestic biofuels. USDA notes that expanding the biofuel infrastructure “broadens the availability of fuels like E15, E85, and B20, made from American-made agricultural commodities.”
March 2025 PFAS Legislative Developments
Federal Legislature
One new bill was introduced.
State Legislature
Sixty six bills were introduced across fifteen states.
Topics include: Exemptions from PFAS bans; PFAS testing requirements; Establishing liability for PFAS contamination; Regulating PFAS contamination in water sources.
State Regulations
NH Env-Dw 1500 was published as a Final Rule. This is a rebate program for well water contaminated by PFAS. The purpose is to establish criteria and procedures for administering the PFAS removal rebate program for private wells.
New Bills This Period
PFAS Legislation
Federal
One new bill introduced.
State
Sixty six bills introduced.
One in CT
One in DE
One in FL
Eight in HI
One in IA
Five in ME
Nine in MA
Eighteen in MN
One in NM
Two in NY
Eight in NC
Two in PA
Four in RI
One in TX
Four in WI
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical Devices; Laboratory Developed Tests (LDTs) (LDT Final Rule). The Court remanded the matter to the Secretary of the U.S. Department of Health and Human Services (HHS) “for further consideration.” The LDT Final Rule would have required companies to obtain FDA clearance in order to continue marketing their LDTs.
The ruling prevents the LDT Final Rule – a rule heavily criticized by many clinical laboratory industry stakeholders – from going into effect. Prior to the LDT Final Rule, FDA exercised enforcement discretion with respect to the regulation of LDTs. The LDT Final Rule would have essentially ended FDA’s general enforcement discretion approach, thereby significantly increasing the regulatory requirements imposed on manufacturers of LDTs.
LDT Background
Historically, FDA has taken a broad enforcement discretion approach to regulating LDTs. LDTs are a subset of in vitro diagnostic products (IVDs) that are designed, manufactured, and used within a single laboratory. Although FDA has long asserted its authority to regulate LDTs as devices, it previously deemed LDTs low risk and, therefore, opted to take a broad enforcement discretion approach with respect to its regulation of LDTs. Under this approach, FDA has not enforced certain device requirements, such as premarket review, reporting, registration and listing, and quality system regulation, against LDT manufacturers.
LDTs, however, have become significantly more complex in the past few decades. Currently, many laboratories manufacturing LDTs employ high-tech instruments (such as algorithms and automation), run LDTs in high volumes, and widely market and accept specimens from across the United States. To address the changing LDT landscape, both FDA and Congress have pursued changes to FDA’s enforcement discretion policy. FDA has previously attempted to modify its enforcement discretion approach through guidance, which was never finalized, and members of Congress have introduced, but failed to pass, new legislation, most recently, the Verifying Accurate, Leading-edge IVCT Development Act (VALID Act).
LDT Final Rule
On May 6, 2024, FDA issued the LDT Final Rule amending FDA’s regulations to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the IVD manufacturer is a laboratory, thus capturing LDTs within FDA’s regulatory purview. Along with this amendment, FDA finalized a policy under which FDA was set to begin a phased implementation of IVD requirements over the course of four years. These phases were set to begin in May 2025.
FDA received over 6,500 comments on the proposed LDT rule, many of which challenged FDA’s authority to regulate LDTs. FDA has continuously asserted that it has authority to regulate LDTs, but that it has chosen to adopt a policy of enforcement discretion. Many clinical laboratory industry stakeholders disagree with this assertion, believing that LDTs fall outside FDA’s scope of authority.
U.S. District Court for the Eastern District of Texas Lawsuit
Within weeks of FDA issuing the LDT Final Rule, the American Clinical Laboratory Association (ACLA) and its member company Health TrackRx filed a lawsuit against FDA claiming that the rule exceeds the agency’s legal authority to regulate LDTs. Then in August 2024, the Association for Molecular Pathology (AMP) filed its own lawsuit describing the rule as “a historically unprecedented power grab.” The two cases were consolidated. Both lawsuits claim the LDT Final Rule must be vacated under the Administrative Procedure Act (APA) because it is “in excess of [FDA’s] statutory jurisdiction, authority, or limitations” and is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law”. See 5 U.S.C. § 706(2).
The Court, on March 31, 2025, entered a judgment in favor of the plaintiffs. In its Opinion and Order, the Court states that, “the text, structure, and history of the [FD&C Act] and [the Clinical Laboratory Improvement Act (CLIA)] make clear that FDA lacks the authority to regulate laboratory-developed test services”. Throughout its opinion, the Court outlines its disagreement with FDA’s expansion and interpretation of the definition of “device” and the agency’s overall interpretation of its authority to regulate LDTs under the FD&C Act.
Specifically, the Court states LDTs are services regulated under CLIA, for which the Centers for Medicare & Medicaid Services (CMS) is primarily responsible for issuing implementing regulations. The Court notes that Congress created a separate statutory and regulatory framework for laboratory test services under CLIA. In its opinion, the Court defines an LDT as “a methodology or process by which a laboratory generates biochemical, genetic, molecular, or other forms of clinical information about a patient specimen for use by the treating physician” and that “[e]ach laboratory uses its own unique knowledge of the protocols, performance characteristics, and means of analysis to develop such methodologies and processes”.
The Court further claims: “Unlike a drug or device, which is a manufactured and packaged article of commerce with user instructions, a laboratory-developed test service is a proprietary methodology performed by only the developing laboratory. That service generates information from test results and transmits that information to the ordering physician. The testing service is not sold as a kit, and the protocol is not transferred in any manner to other laboratories, hospitals, or other facilities outside the developing laboratory entity. No physical product is sold, and no article of personal property is transferred such that title passes from one party to another.”
By employing this particular definition of LDTs, the Court claims that LDTs are services that laboratory professionals perform rather than a physical product sold by a laboratory that could be subject to FDA jurisdiction as a device. As a result, the Court vacated and set aside the LDT Final Rule in its entirety, holding that the LDT Final Rule exceeds FDA’s statutory authority and violates the APA.
Implications
Due to the Court’s order, the LDT Final Rule will not go into effect as planned in May 2025. Unless appealed by the government, this ruling essentially halts FDA’s ability to promulgate further regulations or guidance regulating LDTs. To officially settle the debate of how LDTs should be regulated and to clarify the authority between FDA and CMS, members of Congress would need to act and reinvigorate the VALID Act or similar legislation.
We anticipate there will be further developments on the regulatory position of LDTs. Manufacturers of LDTs should be sure they have data to demonstrate their LDTs have the necessary specificity and sensitivity to ensure the data generated through such tests can be relied upon and have clinical value for physicians, and are consistent with any applicable CLIA requirements.
In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests
In the never-ending saga over the battle to regulate laboratory-developed tests (LDTs), the Eastern District of Texas took the wind out of FDA’s sails on Monday, vacating FDA’s Final Rule that intended to regulate LDTs as medical devices similar to in vitro diagnostic (IVD) tests, which are commercially manufactured and undergo pre-market review by FDA.1 Clinical laboratories can halt their plans, for now, to comply with the Final Rule’s May 6, 2025, deadline to implement certain features of FDA’s medical device quality system regulations.
As summarized in our May 6, 2024, client alert, FDA’s Final Rule was set to dramatically alter the regulatory landscape for LDTs with major regulatory and financial implications to clinical laboratories, patients and health care providers.
Clinical laboratories will see the ruling as a major victory for the laboratory industry. The district court’s ruling also comes as one of the first major checks on FDA’s power in the post-Chevron world following last year’s Supreme Court decision in Loper Bright.
Background and LDT Regulatory Timeline
In 1976, Congress enacted the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), granting FDA explicit authority to regulate medical devices, which included IVDs developed by manufacturers and sold for commercial purposes to laboratories, health care organizations and consumers.
Separate from FDA’s authority, in 1988 Congress passed the Clinical Laboratory Improvement Amendments (CLIA), creating a statutory framework to certify clinical laboratories through quality, proficiency standards and personnel requirements. The Centers for Medicare and Medicaid Services (CMS) oversees CLIA certification and compliance for most laboratories in the country2 that examine materials derived from the human body for the diagnosis, treatment or prevention of disease or to assess the health of human beings.
For decades, FDA did not attempt to assert authority or regulate laboratories or LDTs, which are defined as IVDs “intended for clinical use and that [are] designed, manufactured and used within a single laboratory that is certified under [CLIA].”3 Starting in 1992, FDA claimed that it could regulate LDTs as medical devices through the issuance of a draft Compliance Policy Guide.4 FDA declined to finalize the guidance, however, and assured laboratories that it did not intend to “routinely” exercise its authority over LDTs.5
FDA next asserted that it had jurisdiction over LDTs in a 1996 preamble to a proposed rule regarding device classification levels for certain active ingredients used for preparing LDTs.6 FDA also recognized in the same preamble that “significant regulatory changes in this area could have negative effects” and that FDA would therefore only focus its oversight on “ingredients . . . that moved in commerce” and other tangible articles. FDA never took any final regulatory action to assert its authority over these tests.
In 2010, FDA held a two-day public meeting soliciting feedback on LDT regulation, hinting that it may consider formally regulating LDTs. Four years later, FDA formally released two draft guidance documents proposing a framework for LDT regulation.7 The guidance documents were not well received by Congress, which criticized FDA for significantly shifting the way LDTs are regulated and directed FDA to suspend any efforts to finalize its guidance documents.8 FDA complied and retreated from enacting any final guidance document.
A few years later, Congress considered two different pieces of legislation — The Verifying Accurate Leading-edge IVCT Development Act (VALID) of 2020 and the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020.9 Both bills proposed different approaches to regulating LDTs that would have created a new regulatory pathway under FDA premarket review or deemed LDTs as “services” to be regulated under CLIA. Both bills failed to pass even after being reintroduced in subsequent Congresses.
With failed attempts to regulate LDTs in Congress, FDA announced its attempt to move forward with regulating virtually all LDTs as medical devices in October 2023, which ultimately led to the Final Rule, effective May 6, 2024.
Shortly after the Final Rule went into effect, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) sued FDA in two separate lawsuits challenging that the Final Rule violated the Administrative Procedure Act (APA) because it exceeded FDA’s statutory authority and was arbitrary and capricious. The two cases were consolidated into one.
Summary of Court Ruling
Explaining the storied history of LDT regulation, the district court found no question that Congress had considered the unique regulatory issues raised by clinical laboratories and the tests that they develop and perform, and that Congress chose to regulate these tests as “services” under CLIA. This contrasts with the authority Congress granted FDA to regulate “devices,” which the district court concluded under the FDCA to mean “articles in commerce,” not “services” performed by doctors and laboratories.
Considering the distinct legislative history of medical devices and laboratory services, the district court agreed with the plaintiffs that LDTs are “professional medical services that are qualitatively and categorically different from the tangible goods that FDA may regulate as a ‘device,’” and that medical devices defined under the FDCA only refer to “tangible, physical products.” The district court was further unpersuaded by FDA’s argument that an LDT is an “IVD test system” made up of physical components that meet the definition of a medical device.
Rejecting FDA’s argument on two grounds, the court found that (1) FDA had no statutory authority to alter the definition of a device under the FDCA to expand the definition to include laboratory services, and (2) FDA’s self-created “IVD test system” conflates discrete tangible objects with an assortment of laboratory tools that professionals use to deliver a service. Relying heavily on last year’s Supreme Court decision in Loper Bright, the court closely scrutinized the statute and made it abundantly clear that it was not deferring to FDA’s interpretation of the statute and the authority that FDA was claiming from the statute. The court warned that should it accept FDA’s position, it would lead to limitless implications of FDA oversight on all surgical procedures and physical examinations that use “devices,” giving the term an “extraordinary, expansive meaning with far-reaching consequences.”
The court further noted that, should it accept FDA’s theory that an LDT does in fact meet the definition of a medical device under the FDCA, it would “render[] CLIA largely, if not entirely, pointless.” For these reasons, the court determined that FDA’s “asserted jurisdiction” over LDTs “defies the bedrock principles of statutory interpretation, common sense and longstanding industry practice.” Therefore, the court concluded that the Final Rule exceeds FDA’s authority, is unlawful and should be set aside pursuant to the APA.
Finally, in considering the appropriate remedy, the district court found that the circumstances in this case favor nullifying and revoking the Final Rule instead of remanding the Final Rule back to FDA to modify without vacating. In reaching this conclusion, the court considered the extreme financial impact the Final Rule would have on clinical laboratories as well as the unlikelihood that FDA could justify its decision on remand. Therefore, the Final Rule was vacated in its entirety.
What’s Next?
With the Final Rule now vacated, FDA’s “phaseout” policy to bring LDTs under the same regulatory scheme as IVDs is also terminated. Once the LDT Final Rule went into effect last year, laboratories were subject to a phaseout policy that would have required companies to begin complying with certain medical device requirements, such as medical device reporting and complaint handling, beginning on May 6, 2025.
While it is possible that FDA could appeal the decision, we do not expect the current Administration to do so. Experts had already predicted that President Trump was likely to order FDA to repeal, or not enforce, the Final Rule, as HHS under the first Trump Administration had revoked FDA’s guidance document claiming authority to regulate LDTs as devices.
In light of the district court’s ruling, it seems less likely that Congress, and in particular the Republican controlled House, will attempt to revive the bipartisan VALID Act.
In a town where we are taught to “never say never,” we will keep a watchful eye on the Administration and Congress’s reaction to the court’s ruling.
[1] American Clinical Laboratory Ass’n v. FDA, Case No. 4:24-cv-00479 (E.D. Tex.).
[2] New York and Washington are exempt from CLIA, as they have their own state law regulatory oversight framework, which is enforced by the applicable state agency.
[3] LDT Final Rule, 89 Fed. Reg. 37286, 37289 (May 6, 2024).
[4] See FDA, Draft Compliance Policy Guide: Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. 1992).
[5] Food & Drug Admin., IVD Policy Will Not Include Exemptions for “Standard of Care” Tests, The Gray Sheet (Oct. 11, 1993).
[6] 61 Fed. Reg. 10,484, 10,485 (Mar. 14, 1996).
[7] Food & Drug Admin., FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), and Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Oct. 2, 2014).
[8] H.R. Rep. No. 114-531, at 72 (2016).
[9] VALID Act of 2020, H.R. 6102, 116th Cong. (2020); VITAL Act of 2020, S. 3512, 116th Cong. (2020).
New Mexico Bills Would Expand Protections for Medical Marijuana and Allow Use of Medical Psilocybin
Lawmakers in New Mexico have advanced two bills that would expand protections for medical marijuana patients and permit the use of medical psilocybin.
Quick Hits
The New Mexico House of Representatives recently passed a bill to protect workers from penalties at work for off-duty use of medical marijuana.
The New Mexico Senate and House of Representatives both passed a bill to permit medical use of psilocybin.
The governor has until April 11, 2025, to sign or veto any bill that passes both chambers.
A bill (House Bill (HB) 230) in the New Mexico Legislature would protect employees from being disciplined at work for off-duty use of medical cannabis. HB 230 passed the state House of Representatives on March 12, 2025, and was sent to a Senate committee. It clarifies that an employee could not be considered impaired by cannabis at work solely because of the presence of THC metabolites or components of cannabis in the body. It would prohibit employers from conducting random drug testing for cannabis, if the employee is a qualified medical marijuana patient over the age of eighteen. Random drug testing would be permitted if the employer has a reasonable suspicion of marijuana consumption during work hours that resulted in an accident or property damage.
In 2021, New Mexico legalized the possession, consumption, and cultivation of recreational cannabis for adults twenty-one and older. The state legalized medical marijuana in 2007. The medical conditions that may qualify under the New Mexico Medical Marijuana Program include cancer, anxiety, post-traumatic stress disorder, insomnia, glaucoma, HIV/AIDS, hepatitis C, and multiple sclerosis, among others.
In a growing national trend, recreational marijuana is now legal in twenty-four states and Washington, D.C. Cannabis use and possession remain illegal on federal property under federal law.
Medical Psilocybin
Another bill, Senate Bill (SB) 219, recently passed the New Mexico legislature to approve medical use of psilocybin, sometimes called “magic mushrooms.” If signed by the governor, SB 219 would make it legal for patients to use psilocybin prescribed by a doctor for a qualifying medical condition, including major treatment-resistant depression, post-traumatic stress disorder, substance use disorder, and end-of-life care.
Next Steps
Governor Michelle Lujan Grisham has until April 11, 2025, to sign or veto bills that pass both chambers of the legislature.
In the meantime, employers in New Mexico may wish to review their drug testing policies and practices to ensure they comply with state law, particularly with respect to medical marijuana patients. Employers can discipline or fire workers who use marijuana while on duty or arrive at work intoxicated.
EC Begins Public Consultation on Upcoming EU Bioeconomy Strategy
The European Commission (EC) began a public consultation on March 31, 2025, on the upcoming European Union (EU) Bioeconomy Strategy. The EC states in its March 31, 2025, press release that the Strategy “marks a significant step forward in harnessing the opportunities of the bioeconomy to support European businesses and drive progress towards the EU’s environmental, climate and competitiveness objectives.” According to the call for evidence, the Strategy’s main aims include:
Ensuring the long-term competitiveness of the EU bioeconomy and investment security. The Strategy will identify measures to scale up and commercialize existing and emerging biotechnology solutions and biobased products, in particular by tapping into the significant growth potential of biobased materials substituting fossil-based ones (e.g., sources of alternative proteins, biobased materials, or biochemicals). It will entail looking at practical measures to remove unnecessary barriers to biobased manufacturing and bio-innovation and unleash the full opportunities of primary biobased production;
Increasing resource-efficient and circular use of biological resources, by creating an efficient demand. This means transforming how the EU values and uses biomass resources, prioritizing extended high-value applications while encouraging industries and consumers to embrace circular practices that maximize economic returns from each unit of biomass. It might also entail providing targeted support and incentives for higher value added uses of biomass feedstock and by-products in line with the cascading principle;
Securing the competitive and sustainable supply of biomass, both domestically and from outside the EU. The Strategy will strengthen the role of primary producers, generating wealth in rural areas by creating jobs and diversifying incomes for foresters and farmers and rewarding them for the preservation of ecosystems; and
Positioning the EU in the rapidly expanding international market for biobased materials, biomanufacturing, biochemicals, and agri-food and biotechnology sectors. This will be done by steering existing foreign policy mechanisms in the area of the bioeconomy in the context of the EU’s Global Gateways initiative, exploring the need and appropriateness of bringing bioeconomy under international multilateral fora, and promoting green diplomacy on bioeconomy.
The EC encourages all stakeholders to participate in the online consultation. Comments are due June 23, 2025. Stakeholders can also contribute by participating in targeted sessions on the bioeconomy in upcoming events such as the European Circular Economy Stakeholder Platform (ECESP) Circular Economy Stakeholder Dialogue, taking place on April 10, 2025, and EU Green Week, taking place from June 3 to 5, 2025.
Updates on SB 54: CalRecycle to Take a Second Stab at Implementing Regulations
On 7 March 2025, Gov. Gavin Newsom sent the Department of Resources Recycling and Recovery (CalRecycle) back to the drawing board on proposed regulations to implement the state’s Plastic Pollution Prevention and Packaging Producer Responsibility Act (SB 54). Senate Bill (“SB”) 54 is one of many state extended producer responsibility laws that seek to make product manufacturers responsible for the environmental burden associated with single-use packaging and similar materials. Newsom signed SB 54 into law in 2022, and CalRecycle has been working to implement the law since 2023.
SB 54 targets single-use plastic packaging and food service ware (Covered Materials) and has the lofty goals of achieving by 2032 making 100% of Covered Materials recyclable or compostable, reducing the use of Covered Materials by 25%, and actually recycling Covered Materials at a minimum of 65%.
SB 54 mandated CalRecycle to propose permanent regulations for SB 54 by 8 March 2025. The recently rejected proposed regulations were originally released for public comment in February 2024 and underwent two rounds of public comment. After two public comment periods, CalRecycle arrived at the proposed permanent regulations that Newsom declined to accept. Newsom declined to adopt CalRecycle’s proposed regulations due to the unacceptable burdens and costs the proposed regulations would have imposed on businesses. CalRecycle will have to convene another series of stakeholder meetings and develop new regulations, but CalRecycle’s timeline for proposing these new regulations is not yet clear.
In addition to monitoring the updated rulemaking process for California’s SB 54, our firm is keeping up with several other proposed and enacted state regulations impacting food packaging and food-contact material producers, including the following:
Expected release of CalRecycle’s final “material characterization study” required under SB 343 by 4 April 2025; the report will determine what materials are considered “recyclable” for purposes of “chasing arrows” symbols and SB 54.
Introduced 16 January 2025, Minnesota’s Senate File 188/House File 44 would require food-packaging manufacturers and brand owners to test for and report ortho-phthalates. If enacted, the law would take effect 1 July 2026.
On 20 February 2025, California introduced the Safer Food Packing Act of 2025 to regulate antimony trioxide, bisphenols, and ortho-phthalates in food packaging.
Introduced 3 February 2025, Illinois House Bill 2516 will prohibit the sale or distribution of any cookware and food packaging that contains potentially added per- and polyfluoroalkyl substances (PFAS). If passed, this regulation will take effect 1 January 2026.
Introduced 13 February 2025, Hawaii SB 683 will prohibit the sale or distribution of any cookware and food packaging that contains potentially added PFAS. If passed, this regulation will take effect 1 January 2028.
A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs
The order is in, and the LDT Final Rule is out.
In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests (“LDTs”) as medical devices and, in effect, announced the end to decades of enforcement discretion by the Agency. The deadline to comply with the first phase of the Final Rule was set for May 6, 2025. On Monday, March 31, however, a federal judge in the U.S. Eastern District of Texas ordered that “FDA’s final rule exceeds its authority and is unlawful” and that “[t]herefore, consistent with controlling circuit precedent, the proper remedy is vacatur of the final rule and remand to FDA for further consideration in light of this opinion.”
Epstein Becker & Green’s Life Sciences Team is continuing to review and digest this order and its impact on the clinical lab industry, and we plan to release a more fulsome analysis in the coming days.
In the meantime, we draw stakeholders’ attention to a few key takeaways from the order—namely, the judge’s statement that (1) “the [federal Food, Drug, & Cosmetic Act]’s relevant text is unambiguous and cannot support FDA’s interpretation” and (2) “FDA’s asserted jurisdiction over laboratory-developed test services as ‘devices’ under the FDCA defies bedrock principles of statutory interpretation, common sense, and longstanding industry practice.”
These findings—along with other elements of the district court’s legal analysis—arguably leave little to no room for FDA to salvage its effort to regulate LDTs, absent either a successful appeal of the court’s order or congressional action.
FDA Can’t Stop, Won’t Stop – Navigating the New Administration [Podcast]
In this episode of Food & Chemicals Unpacked, we dive into the current adjustments experienced at the U.S. Food and Drug Administration (FDA) so far under the Trump administration. Keller and Heckman Partner George Misko joins us to discuss the future of food safety regulations, including the downsizing of HHS under Secretary Robert F. Kennedy Jr., potential changes to the GRAS process, and FDA’s ongoing post-market review program.
We Never Know How High We Are Until We Are Called to Rise: Protecting Alabama’s Medical Cannabis Program
There’s a great scene in the movie Wall Street when the up-and-coming Charlie Sheen (pre-Tiger Blood and now that I think about it maybe the precursor to the “winning!” mantra that seems to resonate today) is playing the role of Bud Fox, an eager trader looking to land a job with the biggest whale of them all, Gordon Gecko (played perhaps only as peak Michael Douglas could). Right before his one and only shot at impressing Gecko, Bud looks into the mirror, straightens his tie, fixes his hair, and says “life comes down to a few moments; this is one of them.”
At the risk of being slightly melodramatic, I’m reminded of that scene when I take stock of Alabama’s medical cannabis program as it sits at the intersection of a narrowing legislative window and a judicial proceeding on the brink of success (or failure).
A brief recap of where we stand at this moment. First, on the court side:
Earlier this month, the Alabama Court of Civil Appeals ruled that the Montgomery County Circuit Court lacked jurisdiction to hear the complaints of Alabama Always – an applicant for a medical cannabis license that has not been awarded a license during any of the three rounds of awards – because Alabama Always (and, presumably by extension, any other disappointed applicant for an integrated facility license) had not exhausted its administrative remedies before filing suit. As a result, the Alabama Court of Civil Appeals instructed the circuit court to lift the injunction prohibiting the AMCC from issuing integrated licenses.
And to the Legislature, we recently wrote:
As has become an annual tradition as the medical cannabis program has been in existence, there are a number of proposals currently pending in the Legislature that purport to fix what ails the program.
Sen. Tim Melson has introduced a substitute to Senate Bill 72. As a reminder, the original version of SB72 would have, in relevant part: (1) expanded the total number of integrated licenses from five to seven; (2) shifted the authority of issuing licenses from the AMCC to a consultant; and (3) shielded the decision from any judicial review. And, just as important, licenses wouldn’t be issued until well into 2026, assuming there was no litigation – an assumption I defy any serious person to tell me with a straight face is valid.
After unanimous public disapproval of the proposal, Sen. Melson introduced a substitute bill that would change the agencies tasked with appointing the consultant and would allow for the Alabama Court of Civil Appeals to review the award of licenses if the award was arbitrary or capricious or constituted a gross abuse of discretion. It would also move up the time to issue licenses, but it would still be in 2026, again assuming no lawsuits. While the substitute is a small step in the right direction and an acknowledgment of the flaws in the original bill, I still do not see it as the right path forward.
And here’s why: I reject that Alabama’s medical cannabis program requires a “legislative fix.” I believe that the original medical cannabis law, passed four years ago, isn’t broken.
In light of the Court of Civil Appeals’ decision, we may be mere months away from issuing licenses to dispensaries and integrated facilities.
Once a single dispensary license is issued, Alabama doctors can begin obtaining certifications to qualify patients for medical cannabis and Alabamians with qualifying conditions can begin to obtain medical cannabis cards. So, if you believe that the appellate court offers a path forward that may allow medical cannabis in 2025, why would you press for a bill that would ensure that it isn’t? Put simply, if it ain’t broke, don’t legislatively “fix” it.
Loyal readers of Budding Trends will recall that multiple proposals were voted out of the same committee last legislative session and did not become law. They will also recall that it took more than one legislative session to pass a medical cannabis law in the first place. Is past prologue or is this another example of reform taking time?
Sometimes the hardest course of correct action is inaction. I don’t blame anyone who looks around at Alabama’s medical cannabis landscape and thinks that something (anything) has to be done to fix what they see as a broken program. But I think they are wrong.
I believe that any efforts to engage in any sort of purported compromise legislation, no matter how well-intentioned those proposals may be, is doing a disservice to all applicants and the patients seeking access to medical cannabis in Alabama. The reasoning is simple: If both sides propose legislative changes, then both sides are at least implicitly agreeing that something needs to be done by the Legislature. I reject that premise. I think we are currently on the precipice of launching a medical cannabis program. The appellate courts appear unwilling to abide any further delays from the lower court, and investigative hearings should begin soon. That would allow for the possibility of all licenses being issued in 2025, when the so-called legislative fixes being proposed push us into 2026 at the earliest. Hold the line. Stay the course. And let’s get this program launched. Onward. Forward.
As always, thanks for stopping by.
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FDA’s New Transparency Tool Addresses Chemical Contaminants
Recently, the Food and Drug Administration (FDA) introduced a new online resource called the Chemical Contaminants Transparency Tool (CCT Tool) which allows the public to search for information about different chemical contaminants that may be found in human food. This online, searchable database provides a consolidated list of contaminant levels such as tolerances, action levels, and guidance levels used to evaluate potential health risks in human foods. This tool is part of the FDA’s efforts to modernize food chemical safety and has been launched as part of the administration’s Make America Healthy Again initiative.
Key Features and Objectives of the Transparency Tool
Prior to launch of the CCT tool, tolerances, action levels, guidance levels, derived intervention levels, recommended maximum levels, and advisory levels were to be found (or defined) in 21 C.F.R. parts 109 and 509, and also in guidances for industry. The CCT Tool consolidates this information into one resource, with the goal of making it easier to find information about the contaminants by commodity type.
Here is a snapshot of some data available through the tool:
The levels above show the safety limits for contaminants in food, but do not imply that the presence of these chemical at the specified level is necessarily permissible. FDA’s prior guidances on these chemicals remains an important resource to understand the levels shown in the chart. As explained by acting FDA Commissioner Sara Brenner, M.D., M.P.H., “While it’s ideal to have no contaminants in our food, they can sometimes occur. Eating a variety of nutrient-rich foods from all major groups – vegetables, fruits, grains, dairy, and protein – can help minimize exposure.”
The introduction of the CCT Tool is a useful reminder of the importance of compliance for food manufacturers and distributors. It also highlights the new administration’s focus on transparency for and within the food system, and could be a harbinger of new tools that FDA may develop as part of the new administration’s goals.
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