How long should it take to review a medical device for public use? The FDA’s current average, 73 days, is too much time, according to the medical device industry. Patient advocacy groups however, claim the current process is rushed and at times negligent. A safer, faster approval process would certainly benefit everyone, but enhancements cost money. That’s where user fees come in.
User Fees Explained
Congress passed the Prescription Drug User Fee Act in 1992 when the pharma industry and the FDA recognized the need for an increase in funding to help expedite new drug approvals. With federal appropriations at their limit, the industry agreed to pay user fees with new drug applications, and the FDA committed to meeting target completion dates. The success of this program prompted the device industry to adopt user fees as well, resulting in the Medical Device User Fee and Modernization Act (MDUFMA) in 2002. Both the drug and device user fees are up for reauthorization this year.
Negotiations between the pharma industry and the FDA have reportedly gone well, but the debate between the device industry and the FDA has been more contentious. The device industry wants a quicker review process for low-risk devices, but patient advocacy groups say the process needs more scrutiny, not less. The FDA maintains that safely speeding up the approval process will require a significant increase in user fees. Their request for up to $805 million dollars in user fees was countered by the industry’s offer of $447 million. Some wondered if they would reach an agreement by the February 15th hearing, but on February 1st, the two parties announced they had compromised at $595 million – double the amount previously paid, but significantly less than the amount requested by the FDA.
Faster and Safer?
The increased fees are designed to ensure both a faster and safer review process. The funding will allow the FDA to hire approximately 200 more employees by the end of the 5 year period. Additionally, the deal requires FDA evaluators to meet with representatives from device companies midway through the review process. This will foster communication and hopefully prevent last minute requests for materials that may delay approvals.
At $595 million, a spokesperson for the FDA told Bloomberg Business Week that user fees will account for approximately 35% of their review budget. On the other hand, prescription drug user fees reportedly account for 60% of the drug approval budget. Questions have been raised about the subjectivity of an FDA evaluator whose salary is largely paid by the industry they are meant to be evaluating, but for now, user fees are absolutely necessary in order for patients to benefit from the newest advances in medical technology.
Robyn Melhuish is the editor at MedReps.com, the leading website for medical device sales jobs, pharma sales jobs, and biotech sales jobs. In a competitive industry like healthcare sales, the MedReps.com career center strives to offer candidates breaking news and career advice that will give them the advantage they need.