Senate Begins Debate on Measure To Reauthorize FDA User-Fee Programs

On Thursday, the Senate began debate on a bill (S 3187) that would reauthorize and modify FDA's prescription drug and medical device user-fee programs, The Hill's "Healthwatch" reports (Baker, "Healthwatch," The Hill, 5/17).

Bill Details

The new version of the bill, which was introduced Tuesday by Sens. Michael Enzi (R-Wyo.) and Tom Harkin (D-Iowa), includes several new provisions that have been negotiated since the Senate Health, Education, Labor and Pensions Committee approved a different version (S 2516) last month.

The new bill would:

• Allow FDA to issue final guidance to regulate mobile health monitoring applications, but only after assembling a group of experts and stakeholders and submitting a proposal to Congress;
• Allow the use of foreign studies when considering whether to approve a drug or device;
• Require the agency to weigh patient perspectives when making regulatory decisions; and
• Require FDA to report on ways the agency could accelerate the development of new treatments targeting rare diseases affecting children (Attias et al., CQ Today, 5/15).

Senate Majority Leader Harry Reid (D-Nev.) on Thursday filed cloture on the measure. Reid had warned for several days that he would do so if Republicans did not agree to limit amendments to the bill. Should Senate leaders fail to reach a deal, the cloture vote would be held early next week (Lesniewski, CQ Today, 5/17).

Obama Administration Supports Bill

On Thursday, the Obama administration said it "strongly supports" the bill. In a Statement of Administration Policy, the Office of Management and Budget praised the legislation for including a user fee for the review of generic medications, which President Obama has included in his budget proposals ("Healthwatch," The Hill, 5/17).

The statement also applauded the bill for "enhance[ing] the tools available to FDA to address drug shortages by requiring additional early notification of potential shortages" (Fox, National Journal, 5/17).

User Fees Effectively Reduce Approval Times, Studies Show

Studies have indicated that the user-fee law has worked to reduce FDA drug approval times, the Washington Post's "Wonkblog" reports.

The Prescription Drug User Fee Act dates back to the 1990s, when drugmakers criticized FDA over long wait times for approvals. They settled on a system in which the pharmaceutical industry would pay FDA a "user fee" to help expedite the approval process.

In the first eight years of PDUFA, FDA boosted its reviewer staff by 77% and approval times declined from 27 months to 14 months, according to a Government Accountability Office report.

More recently, a study published Wednesday in the New England Journal of Medicine found that FDA approved new medications two months faster than regulators in Europe and Canada (Kliff, "Wonkblog," Washington Post, 5/17).

FDA, Stakeholders Negotiating National Drug Tracking System

On Thursday, FDA and some industry stakeholders discussed including a provision in the Senate user-fee bill that would create a national drug tracking system to reduce the number of counterfeit medications, Politico reports.

Many health care lobbyists say drugmakers would rather develop a national system, rather than trying to comply with a growing number of state laws addressing the issue. However, FDA officials have said they are not satisfied with industry plans to replace state laws with a "relatively weak national tracking system," according to Politico.

It is unclear whether the group will reach an agreement before the Senate votes on the measure. However, the provision could be added during a House and Senate conference on a final bill (Norman, Politico, 5/17).