Medical-device industry frets over drug issues ruling PDUFA debate

The medical-device industry is gearing up for the reauthorization of a law that is vital to its ability to get new products approved by regulators.

But the industry is worried that its needs will be overshadowed by those of the pharmaceutical industry, which awaits the reconsideration of a similar law governing drugs.

So far this year, more intensive legislative and lobbying activity has centered on the drug industry, with congressional Democrats looking to tie new drug-safety requirements to legislation to reauthorize the Prescription Drug User Fee Act, or PDUFA, a 15-year-old program in which drug makers pay fees to have the Food and Drug Administration (FDA) review their applications for new drugs.

Yet the medical-device industry is keen to get Congress also to focus attention on a similar law that governs the approval process for its products. Medical-device lobbyists expect their legislation to move in conjunction with the pharmaceutical bill and are concerned the disputes between Democratic lawmakers and the drug makers will delay action on both measures.

Like PDUFA, the four-year-old Medical Device User Fee and Modernization Act, or MDUFMA, expires at the end of the fiscal year. Without the user-fee program, the FDA would not have the financial resources to conduct reviews of new devices.

The medical-device lobby also is wary that Congress will make its industry subject to the same proposed safety requirements for prescription drugs.

The medical-device bill is the highest-priority item on the legislative agenda for the industry, which has been preparing for this effort since getting legislation passed in 2004 to amend the original bill.

The Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association and the National Electric Manufacturers Association are in the home stretch of statutorily mandated negotiations with the FDA on a framework for reauthorizing MDUFMA. That agreement will serve as the basis for congressional consideration.
AdvaMed has assembled a formidable team in preparation for MDUFMA reauthorization under Stephen Ubl, a former AdvaMed lobbyist who rejoined the group in 2005 as president.

AdvaMed also hired several former senior congressional staffers over the last two years, including: David Nexon, a former top aide to Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Edward Kennedy (D-Mass.); Ann-Marie Lynch, an ex-House Ways and Means Committee Republican staffer; and Amy Jensen Cunniffe, who previously worked as a White House congressional liaison and as an aide to both then-House Speaker Dennis Hastert (R-Ill.) and then-Majority Whip Tom DeLay (R-Texas).

The HELP Committee held a hearing on PDUFA yesterday that served to launch the formal process of reauthorizing the law.

Lobbyists believe that the HELP Committee could mark up the drug legislation before the end of April, and could include in the package the medical-device bill and the reauthorization of the user-fee program for veterinary drugs.

Rep. Frank Pallone Jr. (D-N.J.), chairman of the Energy and Commerce health subcommittee, confirmed on Monday that the panel could package the device bill along with the drug bill and also is looking to take action by late April.
The HELP Committee also plans a hearing next Thursday on pediatric drug and device safety. On Monday, Reps. Edward Markey (D-Mass.) and Mike Rogers (R-Mich.), both members of Pallone’s subcommittee, introduced a bill with Sen. Chris Dodd (D-Conn.), a HELP Committee member, to promote the approval and safety of pediatric medical devices.
The Democratic majority is eager to take on the powerful drug industry and to pen legislation mandating new safety requirements for drugs. Democrats frequently cite the removal of Merck’s popular Vioxx from the market in 2004, after the “drug” was linked to fatal heart attacks and strokes, as evidence that drug companies and the FDA have failed to adequately protect the public health.

The device industry also has been subjected to congressional scrutiny over safety issues. Just two weeks ago, House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) wrote executives at Boston Scientific and Cordis Corp. demanding information related to their marketing practices for drug-eluting stents, which are tiny devices inserted in arteries that release medicine. An FDA advisory panel recently raised questions about the safety of using these devices for purposes not expressly approved by the FDA.

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