President Obama has signed into law the reauthorization bill to grant the U.S. Food and Drug Administration (FDA) the authority to collect user fees from the medical device industry to guarantee changes in the agency’s performance and accountability.
The medical device industry would pay about $595 million from fiscal year 2013-2017, according to the FDA Safety and Innovation Act. The performance changes would require the agency to report its total time for reviewing devices, reports Rich Daly of ModernHealthcare.com. The bill also could enable the agency to more quickly review medical devices. Also, it would require the agency to implement a corrective action plan to address any deficience found in an independent review.
The legislation sets important accountability, transparency, and efficiency expectations of the FDA medical device review process, says officials at Boston Scientific, a medical device manufacturer. “This bill provides for the opportunity to accelerate the introduction of innovative medical devices without compromise to patient safety,” says Hank Kucheman, chief executive officer at Boston Scientific, in a press release. “We are hopeful that these reforms will have a strong and lasting impact on the FDA’s ability to address lengthening review times, spur innovation and promote faster patient access to new therapies… We look forward to working with the FDA on the implementation of the bill.”
The legislation had its critics. According to the Union of Concerned Scientists (UCS), the drug and device industry spent $700 million lobbying for parts of the bill over the past two years. The UCS says the main problem with the bill is that it doesn’t do enough to strengthen the independence of scientists at the FDA, writes Forbes. One particularly worrisome issue is that the medical device companies will be able to appeal reviewers’ decisions to a supervisor, which could create a climate making it more difficult for FDA experts to require improvements to a device under review. Also, the UCS is concerned that the legislation’s provisions allows medical experts with financial ties to drug and device manufacturers to serve on FDA advisory panels, reports the Houston Business Journal.
Source: “Obama Signs Bipartisan FDA Bill,” The Hill, 7/9/12
Source: “FDA User-fee Bill Clears Senate,” ModernHealthcare.com, 6/26/12
Source: “Boston Scientific Commends Congress on Passage of Bill Reauthorization Medical Device User Fees,” PR Newswire, 6/26/12
Source: “A Health Care Reform Law for the FDA,” Forbes, 6/27/12
Source: “Congress Passes Bill Forcing Pharmaceutical, Medical Device Companies to Pay $6b in Fees,” Houston Business Journal, 6/27/12
Dale McGeehon has been a journalist and editor for more than 25 years, covering chemical regulation and testing for Pesticides and Toxic Chemical News and innovations in material sciences for the National Technology Transfer Center. His writing credits include Omni and College Park magazines and The New York Times.