FDA Misses Deadline to File Financials for Review

Jane Akre
January 24, 2012

The U.S. Food and Drug Administration (FDA) was supposed to submit a new agreement to lawmakers on January 15, concerning how much funding it will need next year to review medical devices and conduct product reviews. Bloomberg reports (here) no new agreement was filed - the FDA essentially missed its deadline.

That may hurt the upcoming February 15 House hearing on FDA funding.

The agency believes as much as $805 million will be needed over the next five years to review applications for new medical devices and the agency may need to hire between 225 and 321 new employees to conduct medical device reviews, Bloomberg reports. That’s the only way approvals can be sped up.

Industry, which pays for its own reviews as part of the Medical Device User Fee, says it’s prepared to pay about $447 million.

Manufacturers in 2007 covered about 13.2 percent of the FDA budget while drugmakers funded about 60 percent of the cost of reviews, according to a Congressional Research Service report.

At the present time, it takes the FDA about 73 days in 2010 to perform a 510(k) review of medical devices. The cost, a little over $4,000. It used to take 80 days in 2001, reports Bloomberg. A smaller company with less than $100 million in sales pays a little over $2,000.

More than 90 percent of medical devices seeking approval make it to the market under the less-stringent, fast-track process known as 510(k), which is an approval for marketing, minus the patient safety and efficacy assurances.

The last agreement in 2007 had industry giants such as Johnson & Johnson and Medtronic paying $295 million over a five-year period to have heart stents and hip implants reviewed.

Advanced Medical Technology Association (AdvaMed), which is the lobby for the medical device industry, has been meeting with the FDA but minutes of the meetings, December 13 and January 5, have not been released according to Businessweek.

There is no sanction for missing the deadline but if a deal isn’t reached soon, Congress can take over the negotiations.

FDA Review Budget

On February 15, the Health sub-committee of the House Energy and Commerce Committee will call Dr. Jeffrey Shuren who oversees medical devices at the Center for Devices & Radiological Health as a witness. The panel is led by Rep. Joe Pitts (R-PA).

We need the FDA to make sure that devices are safe, but we don't need them to stand in the way of cures or jobs," Pitts wrote in a November, 2011 editorial in the Philadelphia Inquirer.

If the FDA and industry don’t reach an agreement by Feb 15, Congress can take over the negotiations.

The current fee system will expire at the end of September. #

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