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FDA User Fee Bills: Why You Should Care February 13, 2012

Posted by Kathleen Blake, MD, MPH, FHRS in Health Policy.
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The U.S. Food and Drug Administration (FDA) relies upon user fees from manufacturers in order to perform product reviews in a timely fashion. The statutes that authorize collection of these fees are reauthorized every five years. The Medical Device User Fee Act (MDUFA) is up for reauthorization no later than September 30, 2012. The FDA has been actively engaged in discussions with manufacturers in anticipation of renewal. An article this week suggests that an agreement has been reached between the FDA and the device manufacturers that will increase the total fees paid over five years to FDA from $295M to an estimated $595M. The fees collected will allow the FDA to hire more evaluation staff during the term of the renewal. Although Members of Congress seem to agree on very little of late, renewal is expected by all parties because the FDA and the manufacturers both depend on the fees allowed by the Act to get products reviewed and approved.

What are user fees?
User fees are paid to FDA by manufacturers for product reviews of devices, drugs, and biological drugs. Payment is required prior to review but does not guarantee product approval, licensing, or clearance. Since Washington has an acronym for everything, the user fee acts (bills) are referred to as UFAs (pronounced “oofas”). These fees are separate from the $2.3 billion excise tax on medical devices authorized by the Patient Protection and Affordable Care Act (PPACA).

This year, there are 4 UFAs: 1) prescription drugs 2) generic drugs 3) biosimilar products and 4) medical devices. The FDA and industry have announced agreement on the terms of renewal of the first three, while the medical device negotiations appear to be nearing completion.

Why should you care about the UFAs?
In addition to earlier access to new devices for your patients, UFAs are sometimes used as a vehicle for other FDA-related legislation. For example, during the 2007 UFA negotiations, a Member of Congress sponsored an amendment that would have mandated Unique Device Identification (UDI) for medical devices. A second draft of the amendment stated that manufacturers were to notify patients with recalled devices directly. If the amendment had passed, manufacturer contacts might have preceded physician interactions with their patients to address a recall.

The 2012 UFA bills are expected to include amendments that address drug shortages, antibiotic development, FDA advisory panel members’ conflicts of interest, pediatric device development, the 510(k) approval process, premarket notification, device innovation, and postmarket surveillance, among others.

What are your concerns about the content of the UFAs? Should manufacturers be required or allowed to contact patients in the event of a recall? Do you think all medical devices should have a unique identifier?

Kathleen Blake, MD, MPH, FHRS
Chair, Health Policy Committee

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