Rep. Paulsen: FDA’s Device Regs Are Inconsistent

Congressman Erik Paulsen said Thursday that the FDA's pre-market review processes lack "consistency, predictability, and transparency," which is making it difficult for firms to bring their products to market in the United States.

The United States is at risk of losing medical device companies to other countries because of the U.S. Food and Drug Administration (FDA) processes to approve devices, according to Congressman Erik Paulsen.

Paulsen spoke Thursday at a House Committee on Oversight and Government Reform hearing called “Pathway to FDA Medical Device Approval: Is There a Better Way?”

At the hearing, Paulsen said that it is getting more difficult for companies to bring devices to market in the United States because of the “lack of consistency, predictability, and transparency in the Food and Drug Administration's pre-market review processes.

One problem that Paulsen cited is that the FDA often proposes new endpoints midway through the device-review process. He said that many companies report that FDA reviewers make new, arbitrary demands late in the product review process.

Small companies, according to Paulsen, are hit the hardest by the problems with the FDA approval process. Paulsen gave New Brighton-based Acorn Cardiovascular as an example.

According to Paulsen, Acorn Cardiovascular had several conversations with FDA staff about how to test its device. The company performed a randomized trial, met its targets, and, in the end, thought the device would be approved.

“But reviewers at the FDA moved the goalposts and required a new trial,” Paulsen said. “Because of this, investors shied away [and] Acorn couldn't raise the capital to perform another multi-million dollar trial and had to close its doors.”

FDA spokeswoman Karen Riley said that agency officials agree with the need for and are working towards greater predictability in the FDA review process, but a lack of predictability was not the reason for Acorn's failure to obtain U.S. marketing approval.

“Acorn was unable to demonstrate a reasonable assurance of safety and effectiveness for the CorCap [device], as evidenced by a fairly consistent record of rejection by FDA reviewers and two separate independent advisory panels,” Riley told Twin Cities Business.

Paulsen claims that the United States is losing its competitive edge because of the inconsistencies in the FDA's approval process, which is ultimately driving companies out of the country.

“If this trend continues, more companies will look for greener pastures and take their innovations and their 400,000 high-paying jobs with them,” Paulsen said.

In January, the FDA released new guidelines to update the 510(k) approval process-a 35-year-old system used to approve the majority of medical devices for market.

The plan contained 25 actions that the FDA intends to implement this year. A handful of those actions have already been put into practice, but most of them are scheduled to be implemented later this year.

Jeffrey Shuren, Director of the Center for Devices and Radiological Health at the FDA, also spoke at Thursday's conference and said that many of the actions that are being implemented in 2011 address concerns that Paulsen outlined.

“FDA recognizes that it can do a better job at managing its premarket review programs,” Shuren said. “And we agree that, in many areas, insufficient clarity, consistency, and predictability on our part contributes to [medical device development] expenses. This is why we've undertaken a number of initiatives to improve our review processes.”

In addition to the 25 actions that are already being implemented, the FDA has identified seven more controversial recommendations that have not yet been decided on. Those recommendations are being reviewed by the Institute of Medicine (IOM), and the FDA expects to receive feedback from the IOM sometime this summer.

Click here to see a list of the FDA's planned actions, including when each action is scheduled to be implemented.