FDA in Flux — February 2026 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

HHS / FDA’s Focus on Rx Drug Advertising Continues; Advisory Letters Being Issued Quickly

What is happening: Since the coordinated September 9, 2025 actions by the Department of Health and Human Services (HHS) and FDA to initiate their “crackdown” on allegedly deceptive prescription drug advertisements, which we outlined here and which included approximately 65 same-day warning and untitled letters to biopharmaceutical manufacturers, the agency has continued to prioritize the monitoring of such advertisements. In some cases, advisory letters have been issued within weeks or even days from a new advertisement’s launch, indicating a marked acceleration in output from FDA’s Office of Prescription Drug Promotion (OPDP).

As of February 14, 2026, the number of OPDP untitled letters issued post-September 9 has already reached 16 — a significant increase from the “few letters a year” average industry stakeholders had gotten used to in recent years. Further, not all of the more recent OPDP letters stem from direct-to-consumer (DTC) advertisements; several have objected to health care professional-directed promotional content as well.

Why it matters: HHS Secretary Robert Kennedy is known to dislike DTC pharmaceutical advertising and has previously stated that his preference would be to “ban” it in the US. Under the First Amendment, however, biopharmaceutical manufacturers have a right to advertise their products in a truthful and non-misleading way, making an outright ban unlikely to survive in court. A more feasible approach to the government restricting such commercial speech is to create unworkable regulatory requirements that result in so much uncertainty for manufacturers that they opt to limit their activities in the area rather than assume unknown risks.

It appears, on their face alone, that certain FDA / OPDP letters have been issued without strong analytical justifications and that the government may be trending in this more restrictive direction. Manufacturers that receive advertising-related letters should undertake a comprehensive review and risk assessment before aligning their course of action in response.

Who may be affected: Irrespective of the merits of some of these OPDP objections, the reality is that a political push for higher volumes of public-facing letters means every biopharmaceutical company engaged in promotional activity could end up receiving one. And while such a missive must be taken seriously, to date FDA has not escalated any of its September 9 (or later) warnings with administrative or judicial enforcement. A warning or untitled letter is “advisory” in that it alerts a company that the agency believes certain conduct may violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), providing the company with an opportunity to come into compliance. It also assures FDA’s lawyers that the entity has been put on notice, thereby decreasing litigation risks associated with taking future enforcement such as a seizure of misbranded products.

Considering the current landscape, we present a bold (perhaps) prediction for 2026: at least one sponsor will take their disagreements with FDA about the allegedly misleading nature of their advertising public, whether through offensive litigation or by becoming the first company to experience the next step in the agency’s enforcement strategy to ultimately stifle biopharmaceutical commercial speech.

Manufacturing PreCheck Pilot Program Officially Launches

What is happening: FDA began accepting electronic applications to the PreCheck Pilot Program for drug manufacturing facilities on February 1, 2026. Applications are due by March 1, 2026, and a team of subject matter experts from the Centers for Drugs and for Biologics will have until April 1, 2026 to select a group of finalists and then until June 30 to announce the pilot’s initial cohort of seven participants. Selection will be based on alignment with current national priorities, such as domestic sourcing of components or improving US patient access to novel therapies. Descriptions of the selection criteria are available on the PreCheck Pilot Program website.

Why it matters: The PreCheck Program is intended to enhance domestic production and supply of drug products by providing early opportunities for interaction with FDA on manufacturing facility design to streamline later regulatory assessments of the facility. Eligible companies must plan to:

• build a new manufacturing facility in the US that will produce sufficient product to meet or significantly contribute to addressing market needs;
• commit to submitting a drug or biologic marketing application; and
• commit to “actively” manufacture products in the facility for at least three years after approval of the products manufactured while participating in the PreCheck Program.

Conferring with FDA subject matter experts on facility layout and quality system design as part of the pilot program may remove or mitigate certain downstream regulatory inspection issues, such as reducing the chance of receiving a Complete Response Letter for manufacturing issues in response to a future marketing application, especially if the facility deploys new technological advancements. But applicants should keep in mind that constructing a facility around agency feedback will not prevent future observations of noncompliance.

Who may be affected: The PreCheck Pilot Program will most directly affect the drug or biological product manufacturers (including CDMOs) selected for the initial cohort. Companies planning to establish or expand operations in the US may benefit from achieving early regulatory alignment with FDA on facility layout, quality system design, and production workflow. Even if the impact on actual design or construction elements is limited, participating companies may derive value from the demonstrated political alignment with FDA and Trump administration policies. Any mitigation of regulatory burdens during product development and approval phases, or during agency inspection, also may help reduce compliance-related costs for participants.

Rare Pediatric Disease Voucher Program Restored by Congress

What is happening: Congress has finally passed a temporary extension of the Rare Pediatric Disease Priority Review Voucher (PRV) Program following two years of intense lobbying pressure. The extension was included in the FY 2026 Consolidated Appropriations Act signed into law on February 3, 2026.

In addition to reauthorizing FDA to award such PRVs until September 30, 2029, the FD&C Act amendment removes prior language that had imposed a superficial deadline for drug developers to have their product pre-designated by the agency as intended for a “rare pediatric disease” (RPD). Requiring designation by a certain date that was earlier in time than the expiry date for the agency to award the PRV never quite made sense when the law otherwise explicitly states that RPD “designation ... is not a prerequisite to receiving” a PRV.

Why it matters: A post-approval PRV that can be used to expedite FDA’s review of another marketing application has significant value to small companies, especially those focused on a single RPD product, due to the ability for such vouchers to be sold as property and transferred on the commercial market (the latest PRV sold went for $200 million in January).

Legislative authorization for the wildly popular program lapsed in late 2024, and although its direct impact had been blunted due to language permitting FDA to award PRVs until September 30, 2026 so long as the underlying products had received RPD designations before December 20, 2024, uncertainty over the program’s fate was beginning to weigh on product developers and investors alike.

Extending FDA’s ability to continue awarding such vouchers through September 2029 is expected to strengthen investor interest in companies developing RPD products and potentially incentivize preclinical companies to move faster on new product development plans.

Who may be affected: Developers of RPD products and the patients they serve celebrated the long-awaited program reauthorization. The EveryLife Foundation for Rare Diseases emphasized that it “costs taxpayers nothing” while incentivizing the development of rare pediatric disease therapies, “many of which would likely never attract investment without this program.”

Although the extension is technically for five years given the program’s expiry in 2024, the delay in getting Congress to act means that the next renewal cycle is a mere three-and-a-half years away. Affected stakeholders may want to push legislators to codify a permanent solution during the next cycle, recognizing that the RPD PRV Program has existed for nearly 15 years and has become an integral part of financing calculations for innovators and investors in the rare pediatric drug space.

FDA Steps Up Enforcement on HIV Specimen Collection Kits

What is happening: FDA issued warning letters in the first six weeks of 2026 to four companies for distributing at-home blood specimen collection kits for HIV testing. The letters state that the kits are adulterated and misbranded because the companies began marketing and distributing them without obtaining any form of pre-market authorization from FDA.

Why it matters: The warning letters signal that FDA continues to prioritize oversight activities relating to specimen collection devices and kits, even after the agency was forced to vacate its final rule to regulate laboratory developed tests (LDTs) under medical device regulations. As we previously observed, FDA can target noncompliant specimen collection kits rather than individual LDTs offered by clinical laboratories. Although such actions do not lead to agency regulation of the lab test itself, enforcing device requirements for specimen collection kits could mitigate potential safety risks related to self-collection, as well as specimen stability risks associated with shipping and handling.

Importantly, where one warning letter recipient claimed that use of the self-collection kit was permissible because the related test was an LDT, FDA responded that the kit itself is a regulated medical device and not part of an LDT. This critical distinction allows FDA to monitor the compliance of clinical laboratories and their business partners with respect to specimen collection.

Who may be affected: FDA’s increased monitoring and enforcement efforts in the specimen collection kit space will heavily impact the clinical laboratory industry, as well as entities that provide specimen collection kit assembly and distribution services. Although the recent warning letters relate only to self-collection kits for HIV testing (which is considered high risk), the agency may begin monitoring the compliance status of self-collection kits for other communicable disease testing. To minimize the risk of FDA scrutiny, clinical laboratories and their partners must comply with applicable device regulations by ensuring, among other things, that:

• the specimen collection devices included in the kit are obtained from FDA-registered manufacturers and, if applicable, are FDA-cleared or -approved;
• use of any device contained in the kit is consistent with its authorized intended use; and
• the specimen collection kit itself is assembled by an FDA-registered manufacturer and properly listed with the agency.

FDA Announces Intent to Tighten Screws on GLP-1 Drug Compounding

What is happening: On February 6, 2026, FDA issued a public statement indicating that it plans to “take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies ... as similar alternatives to FDA-approved drugs.”

What those steps may be remains to be seen, as the agency has not to date initiated any specific administrative or judicial actions toward such intent. Nonetheless, the announcement signals a forthcoming critical shift in the federal government’s oversight of entities compounding this class of drug products as well as business partners that interface with patients to provide access to compounded products, such as telehealth platforms, weight loss clinics, and others. The agency’s statement also refers to enforcement of federal advertising rules, which began last year but is likely to ramp up following the recent announcement.

Why it matters: Compounded drugs play an important and legitimate role in clinical care in the US, with the FD&C Act specifically authorizing the production of such drugs by licensed pharmacists and so-called outsourcing facilities when certain conditions are met. But as we discussed in our June 2025 newsletter, the FD&C Act’s legal framework for compounding does not permit “copies” of FDA-approved drugs to be distributed unless there is a national shortage of a particular product, in which case compounders are key to filling that gap and ensuring the continuity of patient care. It also does not permit compounding of a drug that has never been approved by FDA for any use, because the active pharmaceutical ingredient(s) in such a product would not have been established as safe or effective.

Notably, however, the FD&C Act still subjects all compounded drugs to many safety and consumer-protection oriented requirements, such as the prohibition on false or misleading labeling and the requirement for APIs to come from FDA-registered manufacturers. And among the blizzard of warning letters issued by FDA on September 9, 2025 as part of the pharmaceutical advertising “crackdown” (see above) were nearly 60 letters sent to advertisers of compounded products, including GLP-1 drugs. Each warning letter objected to claims made for compounded drugs, such as them using the “same active ingredient” as the FDA-approved counterpart, references to them being “generic” versions, or suggestions that they are approved in a similar fashion as large-scale manufactured drugs. The agency communicated those actions to the Federation of State Medical Boards to encourage local oversight as well.

There also have been sporadic warning letters (like this one from December 2025) citing the unlawful distribution of unapproved GLP-1 agonists, such as retatrutide, to compounders. (Retatrutide is a next-generation product that is expected to be approved for marketing by FDA later this year; in March 2025 the agency alerted state medical boards to the increasing popularity of the ingredient and its legal status.) FDA’s February 6 statement suggests an increased focus on these kinds of agency surveillance activities, with potentially new strategies thrown into the mix to “restrict” compounders’ access to GLP-1 ingredients.

Who may be affected: Telehealth companies, health care facilities, medical spas, and other entities that have been integral to increasing patient access to GLP-1 agonists through compounding should take heed of the apparent heightened concern FDA is now messaging to the public. Such entities may want to evaluate their prescribing practices, pharmacy partners, advertisements, and public-facing communications for potential compliance risks and take steps to mitigate any high-risk areas that could result in FDA scrutiny.

Additionally, should an entity receive a request for information from FDA, become subject to a facility inspection, or have compounded drug-related compliance issues flagged by a state medical or pharmacy board investigator, the entity should ensure knowledgeable FDA counsel is part of its strategic response team to support development of a comprehensive corrective action plan.

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