Bill Saves FDA Jobs, But Could Hide A Few Land MinesBill Saves FDA Jobs, But Could Hide A Few Land Mines

FROM THE EDITORS

On September 20, Congress approved a bill that renewed FDA funding that would have otherwise run out at the end of September. This bill forestalls FDA's plans to lay off as many as 2000 employees had funding not been approved.

The bill renews for five years programs that enable the agency to continue to collect user fees from drug and device companies. Without the user fees in place by October 1, the agency would not have the funds to keep much of the staff it has hired as a result of the fees. The bill calls for device makers to pay $48 million in fees next year and more than $52 million in 2009.

The 424-page bill focuses primarily on new rules governing the pharmaceutical industry, but a few provisions are aimed at you, and others could be a sign of what is to come. In addition to the MDUFMA-related provisions, the bill contains changes in the approval process for pediatric devices. It also limits the number of conflict-of-interest waivers the agency can grant for members of its advisory committees. In addition, the bill provides for the implementation of a unique identification system and a study of nosocomial infections relating to medical devices.

Compared with the number of pharmaceutical-related items, “overall the legislation has little direct impact on devices,” notes Jonathan Kahan, an attorney with Hogan & Hartson. He notes, though that “there are a couple of provisions that could have an indirect effect on devices, such as the panel conflict waiver provisions.”

However, Larry Pilot says there are a few key items in this bill that might “trip up the device industry.” Pilot is an attorney with McKenna, Long & Aldridge. Among those that are troublesome, he says, is a section that requires a General Accounting Office study on the appropriate use of the process under section 510(k).

“This need for a report by the GAO to determine whether a new device is as safe and effective as a classified device puts a completely different spin on the classification notification process,” he says. “What is the impact of that report going to be in the context of a possible future change in the legislation? This suggests to me an opportunity to tamper with what was a good concept out of the 1976 amendments.”

Pilot also notes that new medical device reporting requirements are worth watching. “The expansion of the MDR authority is quite troublesome because that program simply isn't working. Success has to be measured in the context of early warning and prevention,” he says. In the 20 years FDA has had its MDR system, the program hasn't been evaluated, and this new provision “makes it even more complicated and more onerous,” he says. “It is particularly troubling because it expands greatly upon the language in the statute with regard to reports for a system that is I believe of very little value.”

Pilot suggests that the clinical trials provision may also pose some problems. “The language isn't very clear because it says if you're doing a trial for a 510(k), that information has to be listed somewhere. There's a possible complication here, and this requirement could be onerous to those who undertake a study under the IDE regulation,” says Pilot.

You should certainly take a look at the provisions that address devices, but you should also look at those addressing the pharmaceutical industry, because those may signal what is to come for devices.

“Our clients are worried that the burdensome drug-safety provisions are a template for future changes in the device area,” says Kahan. “We'll have to wait and see. Hopefully, Advamed is attuned to the footsteps that may be coming toward the device industry.”

Sherrie Conroy for the Editors