Panel poised to OK medical-device regulations

A Senate committee is set to advance sweeping legislation regulating medical-device approvals within days of the panel’s receiving the government-industry joint proposal that forms the basis of the bill.

The Food and Drug Administration (FDA) outlined its agreement with the medical-device industry to the panel late Friday, weeks after it originally was expected and five days before the panel was scheduled to mark up a large prescription-drug and medical-device user-fee and safety measure.

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At a Health, Education, Labor and Pensions (HELP) Committee markup today, senators will vote whether to send to the floor a bill that would reauthorize two programs that provide the FDA substantial funding to review new drugs and devices.

The committee issued a summary of the bill late yesterday. The document acknowledges the last-minute addition of the medical-device language and states, “Congress was provided this legislation less than 24 hours prior to the required Committee deadline for filling. The Committee will continue reviewing this proposed legislation. Congressional changes, as required, will be incorporated prior to the floor.”

In addition to the short timeframe available to committee members to review the FDA-industry proposal, the markup also takes place nearly two weeks before the agency convenes a public meeting to hear comments on its agreement with the device companies. The meeting is scheduled for April 30 and the FDA will accept written comments until May 18.

The legislation to extend the Medical Device User Fee and Modernization Act (MDUFMA) is expected to be attached to a larger bill to reauthorize the Prescription Drug User Fee Act (PDUFA) and to beef up the FDA’s authority to promote drug safety.

The committee decided to move ahead on the medical-device language despite the short notice, brought about by a weeks-long stall in the FDA-industry talks, because of deadline pressure. The device and drug user-fee programs expire on Sept. 30.

“It’s probably not the textbook process that we all would like to utilize in putting forward a reauthorization bill,” a spokesman for HELP Committee ranking member Mike Enzi (R-Wyo.) said. Committee Chairman Edward Kennedy (D-Mass.) and Enzi jointly drafted the bill.

Senators and staff have been kept apprised of the process as it moves along, the Enzi spokesman emphasized. “This is an issue that committee members have talked about for quite a while,” he said.

The Senate will have opportunities beyond today’s markup to modify the legislation, including via a manager’s amendment on the floor to the bill that the committee reports. In addition, the upper chamber will have to conference its bill with the House, which has not marked up the drug and device legislation.

While HELP Committee members and staff have had the proposal since Friday, the public has been able to access the agreement since Monday. A Federal Register notice is slated to appear today.

Congress is anxious to move this legislation forward quickly because without these fees, the FDA would lack the funds to review applications for new medicines and devices, which makes this bill a high priority for the industry, the agency and the Congress.

The FDA and the device industry had been meeting behind closed doors for more than a year to develop an agreement on what changes to make to the five-year-old user-fee program, as required under the existing statute.

The Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association and the National Electrical Manufacturers Association represented the device companies during the negotiations.

Last-minute disagreements between the FDA and the device industry led to the delay.

In February, AdvaMed President Stephen Ubl announced that the industry and the agency had arrived at an agreement in principle on the plan they would submit for public comment and to the Congress, lobbyists said.

However, the FDA and the industry reopened their talks after new obstacles emerged, chief among them an FDA proposal to make changes to provisions of the current law that require user fees supplement but not supplant congressional appropriations, lobbyists said.

Under the existing program, if Congress fails to set aside a certain percentage of the agency’s budget for device reviews, the FDA cannot accept user fees. Two years into the program, this so-called “trigger” threatened to bring the user-fee program to a halt, prompting Congress to provide a reprieve in 2004.

Amid pressure from Capitol Hill to finish up the negotiations, the FDA backed off its stance on the modifying the “trigger” as part of reauthorization this year.

In the final agreement between the agency and the industry, device companies would provide $287 million of the $1.25 billion the FDA says is needed for device reviews through 2012. Total fees would increase by 31 percent from this fiscal year to fiscal year 2008, then by 8.5 percent a year through 2012.

Although the FDA would get more total revenues through device fees, the cost of most medical-device application fees would go down, according to the proposal. Smaller device makers especially would benefit from lower fees.

New annual fees would offset the smaller application fees. The FDA and the industry maintain that this restructuring of the fee process would stabilize user-fee revenues, which have been unpredictable year to year.

The agreement also calls for the FDA to meet new performance goals for its device-review process that are designed to shorten the amount of time the agency takes to accept or reject device makers’ applications for new devices or new uses for existing devices.