GOP Players In Health Debate: McCain To HELP; Enzi Adds Finance To Resume

In the face of substantially higher Democratic congressional majorities, two Republican senators have ensured their place in the debate over health care reform and providing Americans with access to safe medicines.

John McCain has joined the Senate Health, Education, Labor and Pensions Committee, bringing to the Republican side of the table long-time support for making drugs more affordable.

Mike Enzi, Wyo., the ranking Republican at HELP, is now a member of the Finance Committee, where Medicare legislation is written and many of the decisions on health care coverage will be made.

The move to HELP, where Chairman Ted Kennedy, D-Mass., is making health care reform a priority, gives McCain a better opportunity to seek at least a discussion of his proposals to shift more responsibility for health insurance choices and costs to individuals.

McCain's campaign proposal caused consternation among big pharma executives concerned that such a shift would accelerate the switch to generic medicines (¹ (Also see "McCain Demand-Side Approach to Health Costs Threatens Drug Sales Growth" - Pink Sheet, 15 Sep, 2008.), p. 15).

McCain's Downside For Pharma

McCain's past vote for allowing the federal government to negotiate prices for drugs purchased under Medicare Part D policies also could cause concern among drug companies, as well as his co-sponsorship of legislation in 2004 to allow imports from specified countries without a safety certification from the Department of Health and Human Services.

Those two positions put McCain more in line with Ohio Democrat Sherrod Brown, a populist and also a member of HELP, than his Republican colleagues.

McCain, along with Brown, then a representative, as well as Sen. Chuck Schumer, D-N.Y., and Rep. Jo Ann Emerson, R-Mo., introduced a bill in 2002 to reform the generic drug approval process by limiting court-related delays for ANDA approvals.

Elements of McCain/Schumer, as the measure was dubbed in the Senate, were eventually incorporated into the Medicare Modernization Act of 2003 that created the Part D benefit. The lone vote against the provisions came from fellow HELP committee member Orrin Hatch, R-Utah.

As the HELP panel renews its debate over an approval pathway for follow-on biologics, McCain may prove to be an asset for generics companies.

During the Generic Pharmaceutical Association's policy conference last fall, an advisor to McCain's presidential campaign noted that the Arizonan's "instincts" are to keep the data exclusivity as short as possible and then change it if innovation appears to be drying up.

The FOBs bill developed by Kennedy and Enzi and reported out in the waning days of the 110 Congress provided 12 years of data exclusivity (² (Also see "Senate Biosimilars Bill Readied For Take-Off In Next Congress" - Pink Sheet, 25 Nov, 2008.)).

Although shorter than the 14 years sought by the brand industry, 12 years of exclusivity is still longer than that desired by generic firms (³ (Also see "Biologics Exclusivity Will Be Less Then 10 Years, Teva’s Marth Vows" - Pink Sheet, 20 Oct, 2008.), p. 25).

With the Senate's FOB proposal nominally set, much of the action will likely shift to the House in the early part of the year, where new Energy and Commerce Committee Chairman Henry Waxman, D-Calif., is waiting to be convinced that 14, or even 12 years of data exclusivity is necessary

But if Senate negotiations are renewed in earnest, the generics industry will need to find another formal champion in the HELP Committee, since Hillary Clinton, who co-sponsored the FOB bill in the last session, has become Secretary of State.

Enzi To Weigh In On Comparative Effectiveness

Enzi, an accountant, takes to the Finance Committee a history of working well across the aisle. He co-authored with Kennedy the Senate forerunner of the FDA Amendments Act that was introduced while Enzi was chairman of HELP, as well as follow-on biologics and health IT bills.

At Finance he will find in Chairman Max Baucus, D-Mont., someone who, like Kennedy, tries to develop bipartisan legislation. In addition to health care coverage, the position at Finance enables Enzi to help craft a comparative effectiveness program (⁴ (Also see "Senate Committee Clears Stimulus Bill With “Comparative Clinical Effectiveness” Funding" - Pink Sheet, 28 Jan, 2009.)).

He believes such a program should give patients "better information about what works" so they can live long, healthy lives, and it should not be used as a tool to deny "access to newer, high-cost treatments," an aide said.

Sens. Jeff Bingamon, D-N.J., as well as Hatch and Pat Roberts, R-Kan., also sit on both the HELP and Finance panels (⁵ (Also see "Sen. Enzi’s Bid For Finance Cmte. Post Could Create Key Broker On Health Reform" - Pink Sheet, 26 Nov, 2008.)).

New Democrats On HELP

McCain is the sole new Republican member of HELP, replacing the retired Wayne Allard, Colo.

Three Democrats have been named to the committee - Robert Casey from Pennsylvania, plus newly elected Kay Hagan of North Carolina and Jeff Merkley, who beat out Gordon Smith for the Oregon Senate seat.

In his campaign to unseat Smith, Merkley criticized Smith's opposition to federal negotiation of prescription drug prices under Medicare Part D and pledged to take the opposite position.

While speaker of the Oregon House, he led bipartisan efforts to enact a bill that expanded the list of those eligible to participate in the Oregon Prescription Drug Program, which purchases drugs in bulk at discounted prices.

Married to a nurse, Merkley also touted his support for fellow Oregon Democratic Sen. Ron Wyden's Healthy Americans Act, which is designed to guarantee universal, affordable health insurance to all Americans.

Hagan supports negotiated Part D drug prices and the reimportation of drugs made in the U.S. from Canada and other U.S. allies, but would require FDA to ensure an imported drug's safety, inspect pharmaceutical facilities, verify chain of custody and register importers.

She is no stranger to biomedical research issues. While in the North Carolina Senate, Hagan supported legislation to provide $300 million for cancer research and treatment and $12.4 million for a building to house the Biomanufacturing Research Institute and Technology Enterprise at N.C. Central University.

The BRITE agenda includes developing tailor-made drugs and finding cures for genetic diseases.

Casey, elected in 2006, has been active in the education arena, but notes that improving health care is one of the motivating factors in his seeking to join HELP. Last year he co-sponsored an academic detailing bill along with Sens. Kennedy, Herb Kohl, D-Wis., and Dick Durbin, D-Ill. (⁶ (Also see "Academic Detailing Bill Could Be Interim Step To Comparative Effectiveness" - Pink Sheet, 4 Aug, 2008.), p. 21).

On The Independence Side of Capitol Hill

At the House Energy and Commerce Committee, where Waxman ousted John Dingell, D-Mich., as chairman, subcommittee chairmen remain the same, facilitating a continuation of last year's efforts to develop legislation affecting pharmaceuticals.

Rep. Frank Pallone, D-N.J., a Waxman supporter, continues as chairman of the Health Subcommittee, and Bart Stupak, D-Mich., a Dingell backer during the contest for committee chair, retains his position as head of the Oversight and Investigations Subcommittee.

Not wasting time, Pallone and Stupak, along with Dingell, who is now full committee chairman emeritus, introduced on Jan. 29 the FDA Globalization Act of 2009 to set fees for inspection of drug facilities and ensure the safety of imported drugs and other products (see ⁷ (Also see "Globalization Bill Creates Fees For Generic Pre-approval Inspections" - Pink Sheet, 2 Feb, 2009.)).

While not a bill that Waxman has been involved with, the globalization measure could provide an opportunity for early action by Energy and Commerce in the health area.

As a consequence of the election results and subsequent shuffling, Democrats added a total five members to the Energy and Commerce Committee and one member to the HELP Committee (see charts: " ⁸ Key Congressional Committees ").

Rep. Edolphus Towns, D-N.Y, is absent from the Energy and Commerce Committee roster. As the new chairman of the Oversight and Government Reform Committee, he plans an aggressive agenda there and has taken a two-year leave of absence from Energy and Commerce, an aide explained (⁹ (Also see "New House Oversight Panel Chair Towns Less Combative With Drug Industry" - Pink Sheet, 5 Jan, 2009.), p. 10).

- Cathy Dombrowski ([email protected])