President Signs Bill To Reauthorize, Modify FDA User-Fee Programs

On Monday, President Obama signed legislation (S 3187) that reauthorizes and modifies FDA's prescription drug and medical device user-fee programs, The Hill's "Healthwatch" reports (Baker, "Healthwatch," The Hill, 7/9).

The Senate and House voted to approve the compromise legislation in June. The programs were scheduled to expire on Sept. 30, but the act reauthorizes them for five years and generates $6 billion in user fees to cover the costs of reviewing new drugs and medical devices.

It includes provisions to address drug shortages, improve drug supply chain safety and establish new user-fee programs for generic drugs and generic biologics, or biosimilar drugs.

More specifically, the legislation:

• Reduces the amount of time FDA has to make administrative decisions;
• Sets a time limit of 270 days for the agency to respond to petitions for generic drug approvals;
• Requires FDA to withdraw guidance documents on when companies must notify the agency of modifications made to medical devices;
• Allows new drugs that treat serious or life-threatening conditions to qualify for an additional five years of market exclusivity;
• Requires the HHS secretary to maintain a public list of drugs affected by shortages;
• Mandates that HHS within 18 months publicly post a proposed strategy for regulating health applications for mobile devices;
• Requires FDA to inspect drug manufacturing sites in the U.S. and abroad that have been flagged for problems; and
• Increases the maximum prison sentence for drug counterfeiting from three years to 20 years, and raises a fine from $10,000 to $4 million (California Healthline, 6/27).

HHS Secretary Kathleen Sebelius in a statement said the legislation will provide FDA with the "tools needed to continue to bring drugs and devices to market safely and quickly and promote innovation in the biomedical industry, and to help secure the jobs supported by drug and device development" ("Healthwatch," The Hill, 7/9).