July 13, 2012 ~ The FDA is eager to secure funding from the medical device industry to fund reviews for the next five years. Industry funds about 20 percent of the FDA's Center for Devices and Radiological Health (CDRH) which oversees medical device reviews. The current budget is set to expire on September 30.
But where is the discussion about patient safety in the Medical Device User Fee Act (MDUFA) hearings ask consumer groups.
Dr. Jeffrey Shuren, head of the FDA's medical device division, has predicted a “Death Spiral” for the FDA if there is not a passage of the Medical Device User Fee and Modernization Act (MDUFMA or MDUFA).
Without a 60-day notification period that their employment is continuing through the MDUFA funding, 250 medical device reviewers, who rely on the medical device user fee program, may seek employment elsewhere. That means MDUFA needs to be approved by the end of July at the latest.
What Industry Wants
The medical device industry has offered to double its funding of MDUFA to $595 million for the next five years beginning next fiscal year in exchange for faster review times and a shorter turnabout to bring medical devices to the market. Background story is here. Dr. Shuren said in a news release (here) that the average total time to pass a 510(k) has increased steadily since 2001, to about 152 days in 2010. About two years ago, Dr. Shuren says the FDA decided to focus on not more or less regulation but “smart regulation.” Industry pushed back that the reviews were unpredictable and inadequate. The FDA began helping industry with poor-quality 510(k) submissions which in turn, put an additional workload on medical device reviewers.
At the same time a high reviewer and manager turnover at CDRH, insufficient oversight amid the growing workload and an increasing complexity of new medical devices, functions and materials has Dr. Shuren expressing frustration and turning to increased user fee resources, supplied by the device industry, as a solution to the quadmire the assembled group that that money is a drop in the bucket when compared to the $350 billion a year in revenues made by the industry and by what it spends to influence doctors and medical associations, to pay foundations, lobbyists, ghostwriters, in criminal fines to the Department of Justice and lastly to injured plaintiffs and their attorneys.
Janet Holt, Regulatory Affairs Director of a patient safety group says what is needed is a patient-focused FDA.
“We asked that clinical trials for all permanently placed medical devices be done before implanted into patients. We asked for patient labeling for all medical devices. We asked for a patient registry for all permanently implanted medical devices. These requests were needed to inform patients so they could make an informed decision and track complications sooner rather than later.”
Written comments by Lorraine Evans, Founder of TVT Mum Support Group asked for a reclassification of surgical mesh devices from a Class II to Class III high-risk category, to create a national TVT/mesh registry, and to increase awareness on reporting adverse events from the clinicians and members of the public.
“To make Americans safe, we must properly fund and properly man and give the best regulatory authority possible to one of the most important institutions in the American government, the FDA. The House of Representatives and the Senate and the President of the United States have to stop using the FDA as a political football. They have to come together in unity to do their most important job: protect the public health!” #