Congress Passes FDA User-Fee Legislation to Address Drug Shortages
Both chambers of Congress have passed the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187) to reauthorize the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act and create user fees to support the FDA review and inspection process for companies seeking approval for generic and biologically similar drugs. The House passed the bill on June 20, and the Senate followed suit on June 26.
The legislation requires drug manufacturers to provide advance notice 6 months before the production of a drug is interrupted or discontinued, or as soon as practical. The bill allows for expedited review of abbreviated new drug applications (or supplements) when these measures can help to mitigate or prevent shortages, as well as expedited inspection or re-inspection of a production facility that could help mitigate or prevent shortages. The bill also calls for more coordination between the FDA and the attorney general regarding drugs subject to quotas under the Controlled Substances Act.
The administration released a Statement of Administration Policy on May 17 in support of the Senate proposal, and President Barack Obama is expected to sign the bill into law. The statement specifically mentions the proposal’s provisions to prevent and mitigate drug shortages. (See “Continued Shortage of Chemotherapy Drugs Causing Concern.”)
In addition, the bill addresses issues related to clinical research and drug and device development. The legislation reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, and includes
- language providing for expedited development and review of drugs that show an effect early in development for serious or life-threatening diseases ("breakthrough" therapies);
- provisions regarding global clinical trials that encourage uniform, scientifically driven clinical trial standards for medical products;
- reauthorization of the Orphan Products Grants Program; and
- authorization of priority review for treatments for rare pediatric diseases.