The Pharmaceutical Research & Manufacturers of America sees a path to enactment of a Medicare prescription drug benefit in 2002.

"I'm very optimistic that enactment of a drug benefit under Medicare can happen in the year 2002," PhRMA President Alan Holmer told a Jan. 25 press briefing in Washington, D.C.

Holmer's scenario for enactment of legislation hinges on quick passage in the House and pressure from the President. "You see a pretty likely scenario that the House passes a drug benefit under Medicare, the President [says], 'that looks pretty good to me, I'd be willing to sign it,' and then there's tremendous" pressure on the Senate to pass a bill.

The House could "pass a proposal by late spring," the PhRMA president suggested, pointing to House Speaker Dennis Hastert's (R-Ill.) support for "a much broader prescription drug plan than he has backed in the past." PhRMA believes Hastert will endorse a bill that would provide $300 bil. over 10 years.

Holmer maintained that the House was ready to move a bill last fall before the terrorist attacks changed the agenda. "When you reflect back on how close they were between the House Ways & Means Committee and the House Commerce Committee working with the Administration on developing a plan, they were ready to rock and roll until things were interrupted tragically on Sept. 11."

President Bush is expected to call for enactment of drug benefit in the State of the Union address Jan. 29, Holmer noted.

Bush's speech will include a call for "economic security," which requires "reliable and affordable healthcare, including prescription drugs," Holmer said. "All the indications are that the President will be proposing a number in his budget that will be at least as large as the number he included in his budget in 2001" for prescription drugs.

Holmer also believes that Sens. Robert Torricelli (D-N.J.) and Blanche Lambert Lincoln (D-Ark.) may be close to signing on to the "tripartisan" Medicare group - Sens. John Breaux, Jim Jeffords (I-Vt.), Charles Grassley (R-Iowa), Orrin Hatch (R-Utah) and Olympia Snowe (R-Maine) - which could then move a bill with "the architecture that's included in the House bill."

Holmer's view of the pressure on the Senate to act if the House moves a bill echoes the analysis of Republican pollster Bill McInturff based on the lessons of past elections (¹ Also see "Healthcare Reform Returns To Political Agenda Heading Into 2002 Elections" - Pink Sheet, 21 January, 2002., p. 27).

PhRMA also cited "clean" renewal of the Prescription Drug User Fee Act as a "high priority" in 2002.

PDUFA "should have a clean extension and we believe it would be very inappropriate for approval of this extension to be bogged down by the addition of controversial amendments," Holmer said. Some Congressional Democrats are pushing for inclusion of Waxman/Hatch reforms in the PDUFA process (² Also see "PDUFA III Or Waxman/Hatch II?: Payors Urge Fix For Generic “Loopholes”" - Pink Sheet, 21 January, 2002., p. 15).

PhRMA wants the issues to remain separate. Holmer noted that generic drugs now account for 47% of all prescriptions, and cited projections that that figure could go as high as 57% in five years. "So I think the generic industry is doing just fine."

PhRMA indicated that it is open to discussions of postmarketing surveillance fees as part of PDUFA III, but stressed that it still sees problems with the concept. FDA has made a formal proposal to industry (³ Also see "FDA User Fee Proposal Calls For Funding Of Risk Management “Toolkit”" - Pink Sheet, 21 January, 2002., p. 16).

"We're very concerned about having user fee money, which was really for the regulatory side...used in the enforcement role," PhRMA Senior VP and General Counsel Russell Bantham said. "It raises very serious concerns about conflict of interest and it looks a lot like tax on the industry," he maintained.

"We do share FDA's and the country's view that our medicines are as safe as possible, but we could see some very serious structural problems really built into the legislation," Bantham said. "I think that's something you have to keep in mind as the discussion goes on, that the actual scope of the program and how the monies are used is part of the discussion we're having with FDA. Hopefully we'll work through that as the process goes forward."

Holmer suggested that the lack of an FDA commissioner has contributed to slower, more difficult negotiations over PDUFA reauthorization. Because "there's not been leadership in the commissioner's office...my sense is that the negotiations regarding the renewal of PDUFA have not gone as well or as smoothly as they did the last time," Holmer said.

PhRMA Sees Path To Rx Benefit In 2002; Wants “Clean” PDUFA Renewal

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