Senate Approves FDA User-Fee Legislation, Sends Bill to Obama
On Tuesday, the Senate voted 92-4 to approve compromise legislation (S 3187) that would reauthorize and modify FDA's prescription drug and medical device user-fee programs, Politico reports (Norman, Politico, 6/27).
The bill, which already was approved by the House, now heads to President Obama, who is expected to sign the measure into law (Perrone, AP/U-T San Diego, 6/26).
Details of the Legislation
The legislation would reauthorize the user-fee programs -- which are scheduled to expire on Sept. 30 -- for five years and generate $6 billion in user fees to cover the costs of reviewing new drugs and medical devices (ElBoghdady, Washington Post, 6/26).
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 would:
- Reduce the amount of time FDA has to make administrative decisions;
- Set a time limit of 270 days for the agency to respond to petitions for generic drug approvals;
- Require FDA to withdraw guidance documents on when companies must notify the agency of modifications made to medical devices;
- Allow new drugs that treat serious or life-threatening conditions to qualify for an additional five years of market exclusivity;
- Require the HHS secretary to maintain a public list of drugs affected by shortages;
- Mandate that HHS within 18 months publicly post a proposed strategy for regulating health applications for mobile devices, as included in the House bill (California Healthline, 6/26);
- Require FDA to inspect drug manufacturing sites in the U.S. and abroad that have been flagged for problems; and
- Increase the maximum prison sentence for drug counterfeiting from three years to 20 years, and raise a fine from $10,000 to $4 million (AP/U-T San Diego, 6/26).