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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 1st April 2012, 07:54 AM
Pharma Newshound Pharma Newshound is offline
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Default FDA Taking Longer to Approve Medical Devices, Says GAO

Source: MedPageToday

GAO: FDA Slows Device Review Process
By Emily P. Walker, Washington Correspondent, MedPage Today

[See the GAO report attached. Also read this Pharma Marketing Blog post: "Medical Device Marketing Don't Need No Stinkin' ROI!" which documents an investigation by Consumer Reports that is critical of the FDA review process for lacking sensible standards regarding what devices need to go through the approval process.]

WASHINGTON -- Although the FDA has met most of its goals for fast-track medical device approvals, it's taking substantially longer to issue decisions on devices than it used to, concluded a report from the Government Accountability Office (GAO).

The report, issued Thursday, also concluded that FDA is inconsistent on meeting its goals for premarket approval applications (PMAs).

GAO investigators looked at approval time in the 510(k) program and found that FDA has met an important goal of reviewing 90% of 510(k) submissions within 90 days every year from fiscal 2005 to fiscal 2010.

However, the clock stops every time a device company is asked to submit additional information. If those delays are factored in, total review times -- from submission to when the FDA issues a decision -- has increased from 100 days in 2005 to 161 days in 2010, the report found.

The majority of medical devices -- ranging from tongue depressors to pacemakers -- go through the fast-track 510(k) approval. To earn 510(k) approval, device companies seeking approval for a low-to-moderate risk device must prove that the device is substantially similar to another device already on the market.

For the more complex PMAs -- which are used for devices which have no similar device on the market -- review time and time to final decision were "highly variable, but generally increased in recent years," the report found. The average time to a final decision for an original PMA was 462 days in fiscal 2003, but increased to 627 days in fiscal 2008.

The report was requested by Sens. Tom Coburn, MD (R-Okla.) and Richard Burr (R-N.C.).

"The GAO oversight report released today confirms a disturbing trend: the FDA is taking longer and longer to make final decisions on life-saving medical devices," the senators said in a joint statement issued Thursday. "GAO also confirms the FDA is not meeting some of its performance goals."

Congress is currently in the process of reauthorizing the Medical Device User Fee Act (MDUFA), which expires in October. The law provides the FDA with user fees from device companies, which cover about 20% of FDA's device review expenses.

The MDUFA agreement currently under consideration would allow the FDA to collect $595 million in user fees from 2013 to 2017, which will allow the agency to hire 208 new full-time staff members, including new reviewers. Adding reviewers to FDA's device staff will lead to shorter wait times for FDA approval of new devices, Jeffrey Shuren, MD, the head of the FDA's Center for Devices and Radiological Health, told a Congressional panel in February.

The long waits for device approvals have been a major gripe in the medical device industry, which says the FDA's slow and inconsistent approval process is stifling innovation.

The Department of Health and Human Services reviewed the GAO report and said that because it appears the back-and-forth between FDA and device companies is what's slowing the process down, "FDA and industry bear shared responsibility for the time increase and will need to work together to improve performance on total time to decision."
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File Type: pdf GAO_MedDeviceReport.pdf (324.9 KB, 85 views)
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Last edited by Pharma Newshound : 1st April 2012 at 08:10 AM.
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