Regulators and those that are regulated agree that legislation passed by Congress earlier this month should speed up the snail-paced approval process for medical devices at the Food and Drug Administration. Meanwhile, the reform effort will be funded in large part with the first-ever user fees levied on device manufacturers.
Under the law, which President Bush is expected to sign, manufacturers submitting devices for FDA approval would pay an average $154,000 application fee, said Mark Leahey, director of federal affairs at the Medical Device Manufacturers Association in Washington. The trade group, which represents many small device manufacturers, had at first feared the bill would threaten innovation with a one-size-fits-all fee schedule, he said, but as it stands, an exemption was built in for small companies that post annual sales of less than $30 million. Such small companies would be exempted from any fees when they first apply, and they would pay $58,520 for every application after that so long as their annual sales stay below $30 million, Leahey said.
Getting the exemption for small companies "was an uphill battle to say the least," he said.
Performance goals also have been built into the bill so that within five years the average 411-day breakthrough-technology review time would be shortened by as much as 25%, according to Leahey. The bill hinges on a congressional appropriation of $15 million per year, but if the money doesn't come through in three years, the entire bill disappears from the books.
Third-party reprocessors of devices designed for single-use only similarly were nervous that they would be crushed by overly strict application requirements, but the law worked out for them as well, said Daniel Vukelich, a spokesman for the Association of Medical Device Reprocessors. There are a few minor changes, but in general the FDA continues to require reprocessors who want to sterilize devices designed for single-use only to submit applications as if they were the original device manufacturers, and it subjects them to the same application fees.
"We can certainly live with it," Vukelich said. "This was a small price to pay and in large part (the requirements) are things we already do."
HHS praised the legislation. Officials said in a written statement that the program offers the FDA "the same type of successful funding system that has been used over the last decade for the agency's drug and biologics reviews."
Leahey said he hopes the FDA section handling devices doesn't follow the example set by the agency's pharmaceutical side. The average drug application fees started at $100,000 when the program was instituted in 1992, he said. Now average fees have grown to $500,000.
The medical device user fees would be retroactive to Oct. 1 once the bill becomes law.
"We have always philosophically opposed the idea of user fees," Leahey said. "But given the financial situation the country is in, we went to the table to get the FDA the resources they need without harming innovation."