May 22, 2012 — In exchange for speeding up the review process, the FDA wants to charge drug and medical device companies user fees. Pharmaceutical drug companies have led the campaign for new user fees that would quicken review times, deal with the backlog of applications, speed the approval of treatments for life-threatening conditions, and enhance surveillance of drugs and devices after they are approved.
The fees imposed on brand-name pharmaceutical companies would increase to $4.1 billion, which is 6% higher than it was the previous year. Fees imposed on medical device companies would double to $609 million. Generic drug companies (which had previously been exempt from user fees) would pay $1.56 billion. Companies making generic versions of biologic drugs (which was not allowed until passage of the Obama health law in 2010) would pay $128 million through 2017. In total, the new fees would exceed $2 billion.
Surprisingly enough, even with the new fees, much of the FDA review process is still federally funded. Brand-name drug makers pay for about 60% of the review process, while medical device makers pay for about 35% of the review process.
The legislation has garnered bipartisan support, and is backed by industry lobbying groups. It is seen as a compromise, but several aspects of the new plan support the interests of medical device companies. For example, instead of having the FDA send a rejection letter when they decide not to approve a medical device, devices companies and the FDA will hold meetings to discuss and resolve safety issues.
Here’s another example: Transvaginal Mesh (a “sling” that is implanted to support a woman’s weakened pelvic muscles and treat incontinence) has caused thousands of severe internal injuries. Transvaginal mesh was fast-tracked through the FDA approval process, through a loophole which allows medical devices that are “similar” to devices already on the market to be approved without conducting safety studies. The problem is, the design for transvaginal mesh was based upon a similar device that was recalled from the market more than a decade ago for safety reasons.
Many public advocates have decried this as a loophole that favors the medical device industry and places the public in harm’s way. In response, lawmakers proposed adding language to the new FDA plan, which would close the loophole and bar clearance of new medical devices if a similar device had been recalled for safety reasons.
Medical device lobbyists successfully negotiated to keep the loophole in place. According to J.C. Scott, the chief lobbyist for the Advanced Medical Technology Association, closing the loophole would have had “a pretty devastating impact on the ability of companies to make incremental improvements on existing products.”
The FDA currently has the authority to review and recall drugs and medical devices, but the agency does not have the capacity to conduct such review on all products before they are approved. Increasing the number of products that are fast-tracked through the approval process could potentially increase the number of unsafe medical devices brought to market.
In the new plan, lawmakers would attempt to protect against this risk by requiring post-market studies. They are also pushing for a system to electronically track devices. Furthermore, drug companies would be required to report drug shortages to give regulators time to find alternative sources.
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