FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

February 14, 2012 ~ What is MDUFA? The Medical Device User Fee and Modernization Act shortened from MDUFMA.

Enacted in 2002 and again in 2007 it authorized the FDA to collect a user fee from industry to review medical devices before they go on sale.

MDUFA in 2010 funded about 20 percent of the medical device reviews out of a $292,707,540 budget. The remainder was through appropriations.

That budget is set to expire on September 30, 2012 so a Subcommittee on Health under Energy & Commerce will hold hearings beginning Wednesday morning, February 15, on the budget for the next five years. A live feed is available (here).

Dr. Jeffrey Shuren of the Center for Devices and Radiological Health will testify. Here are excerpts from his statement (in full here):

What Does it Cost Industry to Review a Medical Device?

Want a review of a high risk medical device? Under MDUFA, a review will cost a large manufacturer $220,050 (a small maker with gross receipts under $30 million pays $55,000).

Want a 510(k) review of a presumably lower-risk medical device? That will cost manufacturers $4,049 per submission and for a small business $2,024.

The time for a review? Ninety percent are approved within 90 days.

What Does it Cost Industry to Review a Drug?

Compare this to the drug review budget, called PDUFA. With a $568 million budget, two-thirds comes from fees from drugmakers. The cost to industry for a drug review by the FDA in 2012 (here) was $1,841,500.

Dr. Shuren says since 2007, the FDA has cleared more than 13,000 medical devices under the 510(k) program. User fees have paid for innovation such as a heart pump for infants and an emergency-use diagnostic test for H1N1. He adds that the fees have allowed the creation of “guidance documents” that benefit industry in bringing new devices to market with fewer regulatory roadblocks.

The majority of Shuren’s statement is focused on working with industry to streamline the approval process. He says the agency began a systematic change two years ago “smart regulation” in an effort to balance industry’s concerns about growing a healthy business, and the consumer’s concerns about the inadequate protection of patients in the face of increasingly complex medical devices and poor assurances of safety.

A 25 point Plan of Action resulted in January 2011 to address the high number of reviewer turnover and poor submissions, partially blamed on insufficient guidance to industry. The Institute of Medicine (IOM) review of the 510(k) process also resulted and last July, it called the process “fatally flawed” and recommended abolishing it. Shuren does not mention that in his address to lawmakers.

What Budget Reviews Will Cost Industry and Patients

The medical device industry and FDA have an agreement in principle - that industry will fund the FDA review process $595 million in user fees over five years. Industry wants “more transparent and predictable” interactions with the FDA in return both before the device review as well as during. The additional cooperation of the FDA requested by industry does not mention patient injuries and outcomes.

On page 17 of his 22 page presentation, Shuren talks about smart regulation and its role in patient safety.

“The U.S. system has served patients well by preventing devices from entering the U.S. market that were later shown to be unsafe or ineffective” he says admitting that a call for greater premarket scrutiny of medical devices is growing outside of the U.S.

“We are pleased that a U.S. medical device industry trade association, AdvaMed, has stated that it supports maintaining our current rigorous standards of safety and effectiveness for marketing medical devices.”

Here is what industry wants for $595 million in user fees:

• Earlier and more transparent and predictable interactions between FD and the applicant, both during the early product development or “pre-submission” stage as well as during the review process:
• More detailed and objective criteria for determining when a premarket submission is incomplete and should not be accepted for review;
• More streamlined FDA review goals that will provide better overall performance and greater predictability, including a commitment to meet with an applicant if FDA's review of their submission extends beyond the goal date, so that the parties can discuss how to resolve any outstanding issues;
• Additional resources to support guidance development, reviewer training and professional development, and an independent assessment of the premarket review proves to identify potential enhancements to efficiency and effectiveness;
• More detailed quarterly and annual reporting of program performance; and
• A joint commitment between FDA and industry to accomplish shared outcome goals to reduce the total average calendar time to a decision for PMAs and 510(k)s. #