The U.S. Food and Drug Administration (FDA) just missed a deadline to submit a new agreement on medical device fees to U.S. lawmakers, as negotiations continue with device makers about what it will cost to quicken product reviews.
Last week, the agency announced a number of agreements involving user fee programs for drugs, generics, and biosimilars, just in time for the January 15th submission deadline to Congress, noted HealthPointCapital. Meanwhile, reauthorization for medical device user fees failed to make its deadline and continues to be negotiated. Now, said Bloomberg Businessweek, the FDA and device industry have until the February 15th House Energy and Commerce health subcommittee meeting to reach a deal. If the date is missed, Congress will handle negotiations.
Under a law enacted in 2007, the industry group—led by Johnson & Johnson and Medtronic Inc.—was charged $295 million over the five-year period since, to ensure that device products were reviewed in a time-appropriate way. The law is scheduled to be reauthorized this year, said Bloomberg; however, some feel it is unlikely that the pact will be reached next month.
The FDA seeks $805 million over the next five years to add 225-331 new staff members to respond to industry and Congressional complaints that its current device approval system is far too slow, said Bloomberg. On December 6th, industry announced it plans to only pay $447 million, said Bloomberg, citing recent minutes.
Ira Loss, senior health policy analyst at Washington Analysis, told Bloomberg that if the February 15th date slips, the agency “will have the wrath of a bunch of exercised politicians on them who are running for re-election and want their pictures on T.V. that night.” Meanwhile, Debbee Keller, a spokeswoman for Republicans on the House Energy and Commerce Committee (the Committee shares oversight over the process with the Senate panel) told Bloomberg by email that no plans are yet in place should a deal not be reached. “We have not reached that point yet, but it is quickly approaching.”
No sanction is in place for the missed deadline, but it is, said Bloomberg, the second such missed deadline. It seems that this July, senators Thomas Harkin (Democrat-Iowa) and Michael Enzi (Republican-Wyoming) asked the agency to submit to it a reauthorization plan by December 31 to allow the panel overseeing the FDA sufficient time to review the plan prior to any hearings, said Bloomberg.
The medical device user fee authorization—MDUFA legislation—was initially passed in 2002; the 2012 authorization will be the third iteration of the legislation, noted HealthPointCapital.
According to industry, regulators regularly make last minute requests for additional information, further slowing review times, despite the fee system, said Bloomberg. For example, the FDA took about 73 days (according to 2010 figures) to complete less-stringent device reviews—the controversial 510(k) process—on products that pose low to moderate patient risks. That figure is down from the 80 days it took before fees were implemented in 2001, according to a Bloomberg Government study. Today, over 90 percent of all devices are fast-tracked through approval via the 510(k), which allows a speedier process if a device maker can prove a new product is similar to an already-approved device.
Bloomberg pointed out that, according to the FDA, the expedited review costs device makers $4,049 per submission for moderate risk products; companies with under $100 million in sales pay $2,024.