Earlier this week, the U.S. House of Representatives approved a bill that secures the funding for the Food and Drug Administration (FDA) for the next several years. Last week, the U.S. Senate passed a similar version of the bill, and leaders from the chambers will now work to come to a consensus, reportedly aiming for July 4 as a deadline to finalize the bill.
The House version of the bill permits the FDA to more than double the user fees it collects from medical device manufacturers. But, in what is likely to be one of the most controversial aspects of the bill, those increased fees will go toward speeding up the approval of new medical products. As you may recall from some of our earlier New Jersey personal injury blog posts, many people had called for the device approval process to become a tougher, more rigorous process, and this seems to do the opposite.
Specifically, the bill reauthorizes the Medical Device User Fee Act, which requires device manufacturers to pay FDA user fees. It also reauthorizes the Prescription Drug User Fee Act, which charges drug manufacturers. Since that bill’s initial passage 20 years ago, it has become the primary source of revenue for FDA drug review programs.
Now, drug and device manufacturers are reportedly willing to pay more for a review and approval process that is more streamlined and consistent. While that will have the positive effect of getting new and essential medications and devices to market and to the people who need them, we can only hope that it doesn’t cause the FDA to overlook health or safety when reviewing new products.
If you or a family member has suffered as a result of a medication or medical device that was improperly approved by the FDA, please contact Breslin & Breslin for a free consultation.
Source: MedPage Today, “House Passes User Fee Bill,” Emily P. Walker, May 31, 2012