SCROLL BELOW FOR UPDATES
User fees have been a bone of contention between the medical device industry and the U.S. Food and Drug Administration, and negotiations have dragged on for a year.
Now, a tentative deal has been reached. The FDA announced Wednesday that in exchange for agreeing to shorter review periods for 510(k) applications and other performance improvements, the FDA is getting $595 million over five years from the medical device industry. The three industry groups with whom the FDA reached a deal were AdvaMed (Advanced Medical Technology Association), the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance.
“The tentative new user fee agreement puts in place a framework that will benefit FDA and industry, but most importantly patients by accelerating the development and approval of safe and effective treatments and diagnostics,” said Stephen Ubl, AdvaMed’s president and CEO, in a press release. “The improvements in the agreement provide FDA and medical technology companies the tools needed to improve the efficiency and consistency of the review process.”
The $595 million will help FDA hire 200 new scientists. At one time, a number as high as $805 million in user fees was also mentioned. But the new amount essentially more than doubles what the industry paid the last time user fees were reauthorized back in 2007 — $287 million.
Congress first established the user fee program a decade ago with the Medical Device User Fee and Modernization Act of 2002 (MDUFA I) because the medical device review program had expanded greatly and prompted concerns about its capacity and performance. The five-year program was reauthorized in 2007 (MDUFA II) and will expire on Sept. 30.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In announcing today’s deal, AdvaMed said that FDA also committed to process improvements such as:
- Provide a substantive interaction with applicants halfway through the targeted time for completion of review, thus ensuring that a company can have time to properly respond to appropriate questions; and
- Implement an analysis of FDA’s management of the review process by an independent consulting organization, coupled with an FDA corrective action plan to address opportunities for improvement.
However, the press releases from AdvaMed and the FDA were scant on details regarding how much shorter the review period will be for 510(k) applications. AdvaMed is holding a press conference this afternoon to discuss the agreement.
UPDATE:
In the press conference, AdvaMed provided more details that will hearten medical device manufacturers.
Shorter review periods will mean that the agency will track average total review times that will progressively improve over the five-year period spanning the agreement. In fiscal year 2017, average total review time — the total time taken for all submissions in a fiscal year divided by the total number of submissions in that period — for 510(k) applications will be 124 calendar days, while that of PMAs will be 385 calendar days. In fiscal year 2013, the corresponding review periods will be 135 calendar days for 510(k) submissions and 395 days for PMA submissions.
Under the current regime, FDA’s review times are based on the so-called “FDA days” — the amount of time between when FDA receives an application and when it issues a letter requesting additional information or announcing a “decision” to clear or reject a submission. For 510(k) applications, this time is 90 days. However, AdvaMed’s president pointed out that the FDA could meet this 90-day goal by issuing a letter asking for more information from a company on day 89, which would delay a final decision. The new program that the two sides have agreed to will look at FDA days in conjunction with average total review times.
“By having a total review time goal that works in concert with an FDA day goal, we will for the first time be measuring (and tracking performance) on a total time basis,” Ubl said. “We think that will have the net effect of reducing review time, which is the most important measurement you can make.”
FDA spokeswoman Karen Riley said that the agency will also have to slowly ramp up its productivity on review times — for instance in fiscal year 2013, which begins Oct. 1, 91 percent of 510(k) submissions should get a final decision within 90 days; and in 2017, to 95 percent of similar submissions between fiscal year 2015 and 2017.
