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La cuenta de honorario médica revisada de usuario del dispositivo del FDA navega a través de casa

por Brendon Nafziger, DOTmed News Associate Editor | June 20, 2012
A revised Food and Drug Administration user fee reauthorization bill sailed through the House of Representatives Wednesday, shorn of a drug-tracking mechanism championed by patient advocates and a provision that would have hampered the FDA's ability to regulate mobile health apps, according to reports.

The FDA Safety and Innovation Act, or S. 3187, passed by a voice vote of more than two-thirds of the House. It's expected to come before the Senate again next week.

The bill reauthorizes the user fee programs for drugs and medical devices for another five-year chunk, letting the FDA collect more than $6.4 billion from manufacturers to help them speed up review of new products. The current user fee authorization expires in October.

Under the bill, device makers' fees will jump to $595 million, to be collected from 2013 to 2017. But in return for the higher fees, the FDA has to meet certain performance milestones, including reporting back total review times.

For the first time, the bill also authorizes the collection of user fees on generic and biologics developers, to help improve regulation of those industries.

The legislation is a compromise between two House and Senate bills, both passed last month.

Representatives spent much of the time allotted for the debate on the legislation in the House Wednesday congratulating each other on passing what they called a bipartisan, bicameral bill that could serve as a model for how Congress could work if it so chooses.

"This is a good piece of legislation," Rep. Joe Barton, a Texas Republican said, summing up the general mood in the lower chamber.

Not everyone is entirely enthusiastic, though. Patient advocates are miffed that certain regulations were dropped from the final bill.

For instance, an AP report said the Senate bill initially included a provision to track drug shipments as they move through the supply chain to protect consumers from counterfeit medication. The provision got struck out of the final revised House bill because of disagreements between the pharmaceutical industry, which wanted tracking at the lot level, and the FDA and patient advocates, which preferred tracking at the bottle level, according to the AP.

"This bill includes some important reforms that will improve the FDA's ability to monitor medical devices on the market and to notify patients and require stricter testing when safety problems arise," Lisa McGiffert, who directs a patient safety project with Consumers Union, a consumer advocacy group, said in a statement. "But there is clearly more work that needs to be done to ensure that the FDA has all the tools it needs to ensure medical devices are safe and effective before they can be used on patients."

Nonetheless, there are some things Consumers Union is happy about, such as a requirement for the FDA to issue guidelines in the next six months to set up a unique device identification (UDI) system, to better track medical devices once they're on the market.

Also, according to an mHIMSS report, the new bill does away with an earlier Senate provision that would have required the FDA to get feedback from industry stakeholders before releasing guidance on mobile health app regulations. Instead, the provision was changed to simply require the Department of Health and Human Services to consult the FDA and other groups to develop a report on the matter. But in the meantime, the FDA can release its guidelines, according to mHIMSS.

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