Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and food industries. Specifically, the FDA has:
- published more than 200 decision letters, known as "complete response letters" (CRLs), that were issued in response to new drug applications (NDAs) and biologics license applications (BLAs) submitted to the FDA for approval between 2020 and 2024
- issued a statement "encouraging" manufacturers of baby food, infant formula and other food for children to work with FDA to "improve public awareness" about product recalls
- stated that the agency may fast-track new drugs from pharmaceutical companies that "equalize" the cost of their medicines between the U.S. and other countries.
These new policies, if finalized, could have significant implications for FDA-regulated industries.
Complete Response Letters
On July 10, 2025, the FDA issued a statement announcing that it had published more than 200 CRLs for drug and biological products that sought and received FDA approval between 2020 to 2024. FDA Commissioner Dr. Martin Makary also noted the FDA "is in the process of publishing additional CRLs" and will be looking for other ways to provide the public "with greater transparency into its decision-making process."
CRLs are sent to sponsors of drug and biological product manufacturers to explain the FDA's rationale for declining to approve a product in its current form. (The CRLs are available online.) Historically, individual letters are not routinely made public while a product is undergoing FDA review – often to protect the confidentiality of product information and data produced during clinical testing – but are required by the FDA Amendments Act of 2007 (FDAAA) to be posted online as part of an action package after a product is approved. The FDA has historically published CRLs on either its online database or on various biologics product pages.
In its announcement, the FDA said the published CRLs were redacted for trade secrets and confidential commercial information. It is not clear, however, whether product sponsors who had received the CRLs had advance knowledge that FDA was releasing the information or had input into the redaction process. Sponsors are encouraged to review this database and confirm no trade secret or confidential commercial information has been inadvertently disclosed in recently released CRLs. Though some stakeholders generally support the FDA enhancing transparency around its decision-making processes, additional information regarding the timing for the publishing of additional CRLs – such as after product approval or as letters are issued – will be a significant determining factor for how helpful the CRLs are. For instance, if a CRL identifies manufacturing or clinical data issues with an application, competitors may use this information to inform their own regulatory strategies. Similarly, generic manufacturers and sponsors of 505(b)(2) applications could potentially review CRLs to make early determinations regarding Paragraph IV challenges, as well as gain insight into the innovator's approval timeline or labeling decisions. Sponsors with applications before the FDA should be aware of the FDA's disclosure and consider potential future disclosure of their CRLs when marking submitted materials as containing trade secrets and/or confidential commercial information.
Recalls of Baby Food, Infant Formula and Other Children's Food
On July 9, 2025, Dr. Makary sent a letter to "manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of infant formula, baby foods, and foods intended for children." In the letter, Dr. Makary stated that the FDA is seeking industry assistance in "creating a collaborative transformation in how we manage and communicate food recalls, particularly for infant formula, baby foods, and foods intended for children, to provide for greater public awareness of these recalls." This aligns with its announcement of short- and long-term goals for improving recall notifications and increasing consumer awareness. With this announcement, the FDA continues to rely on voluntary compliance from industry, similar to its approach in the food additives and petroleum dye spaces, rather than issuing new regulations.
The July 9, 2025, letter lists short- and long-term goals the FDA seeks to achieve through a new communication process.
Short-Term Goals
- enhance public access to critical recall information by creating a centralized, consumer-focused webpage for streamlined access to recall information, with an emphasis on infant formula, baby foods and foods intended for children
- evaluate internal and external recall communication protocols on public communications for certain recall situations, ensuring alignment with current best practices and public health priorities
- improve recall data granularity and accessibility by upgrading the FDA Enforcement Report system to allow for more refined and targeted filtering of recall information by the public, particularly for sensitive food categories
- improve the reach and clarity of FDA recall communications by leveraging focus group research and other stakeholder feedback on risk communication strategies
- further increase the speed of recall classification through process improvements
Long-Term Goals
- optimize recall information collection by redesigning and digitizing key recall documentation to support automated data extraction and artificial intelligence-assisted analysis, improving overall recall process efficiency
- modernize data submission infrastructure through implementation of an advanced digital platform for industry partners to submit standardized data, enhancing efficiency in recall information processing, dissemination and classification
Notably, the July 9, 2025, letter says the FDA "welcomes industry input" but does not announce a new request for information (RFI), public comment opportunity or proposed rule, indicating that stakeholders may need to initiate contact directly with the FDA to provide feedback or input into these new efforts. Moreover, FDA's recall authority is limited without additional statutory and regulatory action.
Drug Reviews and Drug Prices
On July 11, 2025, during a TV interview, Dr. Makary said the FDA may be inclined to provide a faster review of drugs if the manufacturer "equalize[s]" the cost of the medicine between the U.S. and other countries. This caught FDA stakeholders by surprise, since the FDA does not have pricing authority and typically avoids pricing discussions. Dr. Makary's comments shed additional light on how the FDA plans to implement the Commissioner's National Priority Voucher (CNPV) program, which was launched in June 2025 and seeks to reduce the review time for a new drug product if it advances certain national health priorities. (For details of the CNPV program, see Holland & Knight's previous alert, "FDA Announces 'National Priority Voucher' Program to Accelerate Reviews of New Drugs," June 20, 2025.)
Since the program was announced on June 17, 2025, additional details have emerged. The CNPV program will operate as a one-year pilot with the potential to grant additional numbers of vouchers in the coming years. In addition, vouchers granted through the CNPV program must be used within two years of receipt from the FDA. The FDA continues to note it will provide information in the "near future" on how companies interested in applying for a voucher may do so and, in the meantime, has set up an inbox for inquiries.
Though the initial announcement of the CNPV program did not stipulate that manufacturers would be required to adjust their prices to qualify for a voucher, any one or more of the following criteria were outlined as determining factors for which manufacturers would receive a voucher:
- addressing a health crisis in the U.S.
- bringing potential innovative therapies to the American people
- addressing unmet public health needs
- significantly increasing the national security of the U.S.
In addition, the supplementary materials published on the FDA's website also indicate that voucher recipients may be chosen based upon factors "including but not limited to" the above four criteria, indicating that the commissioner may opt to consider the launch price of a drug or biological product when choosing whether to grant a voucher. This represents a potentially significant change in the types of information sponsors provide to the FDA, as nowhere in the Federal Food, Drug, and Cosmetic Act (FDCA) and the regulations promulgated thereunder are there requirements to compel sponsors to provide the FDA with proposed pricing for a drug product, nor are there provisions granting the FDA the authority to take a specific action on a drug such as approving or denying it based on the price to be charged.
