Device Industry Pushes for Lower FDA Fees

Medical device companies are negotiating with the FDA to pay lower fees for product approval, according to the Associated Press

In closed-door talks, industry group officials and FDA officials are reviewing the agency’s user-fee program

The goal of the program was to hire additional FDA staffers to help speed up approval times for medical devices

”There’s a real consensus among industry that we haven’t seen the type of performance we expected,” says Patricia Garvey, a recently retired vice president with heart-valve maker Edwards Lifesciences. Garvey is a key negotiator for AdvaMed, an industry association that represents more than 1,000 companies, including market leaders Medtronic, Boston Scientific and Johnson & Johnson

Nearly 70 percent of industry executives surveyed do not believe user fees have resulted in faster, more reliable product approvals, according to a study released by FDA earlier this year

The agency has made modest improvements in some areas. New product approval took 294 days on average in fiscal 2004 compared to 346 days in fiscal 2001, the FDA says

But the FDA is getting further away from goals set when the program was launched. For example, by 2007, when the program is due for budget reauthorization, the FDA wants to be reviewing at least half of all applications within 180 days of submission

That could happen. But the trend is worrisome. According to the most recent FDA data available, the number of applications reviewed within six months of submission fell to 39 percent in 2004 from 49 percent in 2002.

Meantime, device makers complain that fees have soared 82 percent since the program began. They were $154,000 in 2003 per application and will be $281,000 in 2007.