Thursday, January 25, 2024


FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2022 for Use in Food-Producing Animals

Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine published the 2022 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This year’s data show that domestic sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals increased by four percent between 2021 and 2022; compared to 2015 (peak year of sales), 2022 sales were down 36 percent. Sales volume may fluctuate over time in response to various factors, including changing animal health needs or changes in animal populations.

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FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act

Ensuring reliable patient access to safe and effective medicines requires every link in the supply chain to be secure: from the moment a drug leaves the manufacturer until it reaches a pharmacy or health care professional’s offices. Since 2013, the U.S. Food and Drug Administration has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful.

Requirements of this law improve supply chain security activities by trading partners, for example, prescription drug manufacturers, repackagers, wholesale distributors, third-party logistics providers (3PLs), and dispensers, primarily pharmacies. Gradual implementation of the requirements for product tracing, product identification, authorized trading partners, and verification, is helping trading partners develop required systems for interoperable, electronic tracing of products down to the package level. Interoperable electronic systems are those that can exchange data accurately, efficiently, and consistently about each package (i.e., smallest individual saleable unit) as it is distributed in the U.S.

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 On Monday, the FDA announced the launch of its Cosmetics Direct electronic submission portal for registration of cosmetic product facilities and listing of cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The FDA also issued a final guidance for industry on registration and listing of cosmetic product facilities and products. The final guidance also includes a new draft section, for public comment, that describes frequently asked questions and answers. The final guidance and new electronic submission portal are part of our continuing efforts to advance the implementation of MoCRA. With MoCRA’s new registration and listing requirements, the FDA will have a more complete picture of the cosmetic products distributed in the U.S.

 FDA has received reports of consumers who have used fat-dissolving injections that are not FDA approved and that have caused adverse reactions, including permanent scars, serious infections, skin deformities, cysts, and deep, painful knots. Some consumers received the injections at clinics or med spas by personnel who might not have been properly licensed to give the injections. In addition, some consumers who reported adverse reactions purchased the unapproved fat-dissolving drugs online and injected the drugs themselves.

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FDA Issues Final Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species (MUMS)

The U.S. Food and Drug Administration has released updated information to help animal drug researchers and sponsors navigate the pathway to approval for animal drugs intended for minor uses and minor species (MUMS).

The final guidance, entitled, “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,” was released as a draft guidance in July 2020 for public comment. The comment period was extended to 180 days in order to hear from all interested parties. The agency received many comments on the proposed Aquaculture Species Grouping section of the draft guidance; the agency intends to address aquaculture species grouping in greater detail in the future. Other revisions were made in response to public comments and to improve clarity.

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 On Dec. 28, 2023, the FDA issued a new guidance to help drug manufacturers limit consumers’ and patients’ exposure to unacceptable levels of benzene in certain drug products. The guidance provides manufacturers with recommendations for testing and documentation related to reformulation of drug products that use carbomers manufactured with benzene, taking into consideration the various routes of administration and dosage forms of affected drug products.

 On Dec. 27, 2023, the FDA also revised the draft guidance for industry, Quality Considerations for Topical Ophthalmic Drug Products, to articulate important changes, including added information about product sterility and preservative use, as well as a clarified scope regarding drug products that are not marketed under section 505G of the Federal Food, Drug and Cosmetic Act, or pursuant to an FDA approval or licensure. To read the revised guidance and for more information on how to submit comments to the docket, visit the guidance page. 


FDA Authorizes Florida’s Drug Importation Program

Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.  

Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety. 

Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs to be imported. Among other obligations related to this SIP, before drugs can be imported, Florida’s Agency for Health Care Administration must:

  • Submit additional drug-specific information for the FDA's review and approval
  • Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity  and compliance with the FDA-approved drugs’ specifications and standards
  • Relabel the drugs to be consistent with the FDA-approved labeling

In addition, Florida’s Agency for Health Care Administration must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues. 

“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said FDA Commissioner Robert M. Califf, M.D. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

The FDA will exercise oversight to help ensure the authorized proposal is followed and that Florida’s program continues to meet the requirements in section 804 of the FD&C Act and the agency’s regulations. Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures and reporting quarterly to the FDA. The sponsor of any program the FDA authorizes is responsible for implementing all aspects of their program such as importation and distribution.

States and Indian tribes may submit SIP proposals to the FDA for review and authorization under section 804 of the FD&C Act. Prior to authorization, a SIP proposal must provide all the information required by the FD&C Act and the FDA’s regulations

The FDA previously posted a small entity compliance question-and-answer guide and developed Tips for SIPs to assist sponsors in developing their proposals as a part of the agency’s ongoing commitment to working with interested states and tribes.



FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives. 

In 2023, CDER approved 55 novel drugs, as detailed in our annual New Drug Therapy Approvals report. The active ingredient(s) in a novel drug have not been previously FDA-approved. We also took other important actions, such as expanding the indications or patient populations of some previously approved therapies. In addition, we approved new dosage forms or drug formulations and made some prescription drugs available over-the-counter.

Our 2023 actions target a wide range of disease areas. For example, we approved treatments for infectious diseases, including COVID-19, respiratory syncytial virus (RSV), and HIV. CDER also approved therapies for neurological conditions, such as amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and migraine. Moreover, we took approval actions for drugs targeting type 2 diabetes in children, different types of anemia, and chronic weight management, among other heart, blood, kidney, and endocrine disorders.

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