The Senate and House of Representatives have passed their bills that authorize the U.S. Food and Drug Administration (FDA) to collect user fees so that the agency can review new drugs and medical devices, and they are heading to a conference to be reconciled.
The legislation reauthorizes the FDA’s drug and medical user fee programs for five years, beginning in fiscal year 2013. Industry-paid user fees pay for about 60% of FDA’s drug review budget and 20% of the device center budget, reports Britt E. Erickson of Chemical and Engineering News.
Both fee programs are set to expire on Sept. 30, the end of the fiscal year for the federal government. If Congress does not pass the reauthorization bill before then, FDA will have to lay off about 2,000 employees, and its drug and device review process will cease.
The two versions of the bill, which passed each chamber easily, have a few significant differences, one of which concerns the medical device oversight process. Politico explains this difference:
Unlike the Senate bill, the House bill does not streamline the FDA’s ability to reclassify medical devices into categories that require more stringent review. The House also lacks a timeline for implementing a unique device identification system, which would make it easier to track faulty devices.
In a related matter, Consumers Union, the policy and advocacy arm of Consumer Reports, wants the bill to require device makers to prove they have fixed design flaws when they want to sell a new device based on one that has been recalled by manufacturers for safety problems, reports Clarksville Online. The organization is urging lawmakers to give the FDA the authority to require device makers to demonstrate that the safety flaws have been corrected in the new device.
Lisa McGiffert, director of Consumers Union’s Safe Patient Project, says:
It’s time to close this absurd loophole and give the FDA the power it needs to protect patients. But so far, the politically powerful medical device lobby has blocked this common sense reform. Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients.
The medical device industry claims that the agency has the authority to address this problem. But Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, has confirmed in interviews that the agency does not have the power to prevent device makers from repeating safety flaws when new devices are cleared based on their similarity to ones recalled by manufacturers. Neither bill closes this loophole.
Source: “FDA User Fee Bills Sail,” Chemical & Engineering News, 5/31/12
Source: “FDA bill heading to easy conference…,” Politico, 5/31/12
Source: “Consumer Union Says Dangerous Medical Device Loophole Puts Patients at Risk,” Clarksville Online, 5/27/12
Image by Kathrin Tausch, used under its Creative Commons license.
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.
[...] 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 [...]