Shakeups are underway at the Food and Drug Administration, specifically in the areas of medical devices and drug research.
Daniel Schultz, is leaving the FDA’s medical device division “by mutual agreement” with FDA Commissioner Margaret Hamburg.
The medical device division of the FDA has been the subject of questionable approvals, including malfunctioning defibrillators, and the synthetic surgical mesh IB News reported on in “Suffering in Silence.”
Synthetic mesh has not been reviewed for safety, but is approved for marketing if it's “substantially equivalent” to some other product on the market under the agency’s 510(k) approval process.
Even when that “predicate device” is removed from the market over safety concerns, as happened in the case of Ethicon's TVT synthetic surgical mesh, there is no procedure within the agency to re-review the subsequent devices.
Earlier this year, nine scientists spoke up to incoming President Obama that they had concerns about how medical devices were approved without adequate checks for effectiveness and safety.
Then in April, the agency asked manufacturers for more proof their devices already on the market were safe.
Companies such as Medtronic, Royal Philips Electronics, Zoll Medical Corp, Covidien, Zimmer Holdings, Johnson & Johnson, and Abiomed, were all asked to provide additional proof of safety. The companies may have to pay for additional clinical trials or have them reclassified as less risky.
Sen. Chuck Grassley has also been looking into why devices were approved over the objections of scientists and doctors, reports the Wall Street Journal.
And the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, is under investigation for alleged conflict of interest, according to the Wall Street Journal.
The alleged conflict came to light when a drug company, Amphastar Pharmaceuticals, filed a complaint that a competing firm had access to Woodcock at critical times during the approval of a generic blood-thinning drug.
Amphastar complains that Dr. Woodcock even co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. which gave them a market advantage. The company has asked her to recuse herself from the issue within the FDA.
Dr. Woodcock has been with the agency for 20 years. The inspector general of the Department of Health and Human Services is conducting an ethics investigation. #