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Backers Mull Clinton Impact on Biotech Bill

Lobbyists pushing for a bill that would help bring generic versions of biotech drugs to the marketplace are worried that one of the measure’s chief advocates — Sen. Hillary Rodham Clinton (D-N.Y.) — might inadvertently be helping to repel GOP supporters.

Clinton’s high-profile backing for the bill, which proponents say could lead to dramatic health care cost savings, has been welcomed by its supporters. But several lobbyists said Republicans, particularly those on the Health, Education, Labor and Pensions Committee, have indicated they don’t want to hand Clinton a victory on something she could tout on the campaign trail.

“The idea that her proposal is nuclear for some Republicans, that is strictly about presidential politics,” said one lobbyist who supports the bill but would not be quoted by name. “The policy is good and makes sense for Republicans.”

Other GOP lobbyists working in support of the bill said they view the Clinton factor as an excuse for Republicans who don’t want to cross big biotech and pharmaceutical companies that oppose the measure, which has a companion bill in the House sponsored by Rep. Henry Waxman (D-Calif.).

“The Clinton thing might be more of an excuse than the real reason, but it’s handing Republicans a convenient excuse of ‘we don’t want to see her get promoted as taking on this big national health care issue,’ and it will be prominent in the campaign,” said one Republican lobbyist working for the bill. “The folks who are arguing ‘Hillary’ simply want [the proposal] dead.”

Those pushing for the bill include pharmacy benefit management companies, generic drug makers as well as a coalition of some of the biggest employers and unions that want lower health care costs.

Mark Merritt, president and CEO of the Pharmaceutical Care Management Association, which represents the pharmacy benefit management companies, said Clinton’s position on the issue puts her on the side of most of the business community — a place where Republican Members would seem comfortable. Merritt said the excuse by some Republicans over Clinton’s leadership on the issue “might be a little bit more of a smoke screen.”

“People who have enjoyed the support of both the drug lobby and the business community will have to make a choice,” he added.

But some Democrats working the issue say they aren’t buying the Clinton excuse, and they point out that the bill does have GOP supporters including Sens. David Vitter (La.) and Susan Collins (Maine).

“She’s a very good, serious legislator, whenever she works on a major issue, it’s always with strong bipartisan support,” said Rich Tarplin, a lobbyist at Timmons and Co. who was assistant secretary for legislation at the Health and Human Services Department during President Bill Clinton’s administration. Tarplin is pushing for the bill in both the House and Senate on behalf of generic manufacturers. “We’re no longer talking about whether there is going to be a new generic pathway for biologics, we’re talking about the details of how it’s going to be designed.”

Biologics are complex therapies that are often made from living cells and mimic functions that occur in healthy people.

Vitter, for one, sees the issue as a no-brainer.

“Generic drugs significantly lower medical costs for Americans and bring many life-saving drugs within affordable reach. But biological-based drugs — which are among the most expensive on the market — cannot be produced generically under current law,” said Vitter in a statement. “Insulin is a prime example, and with Louisiana having the highest rate of diabetes in the United States, this bill is crucial to ensuring that life-saving medicines are reasonably priced.”

Yet, lobbyists on both sides of the debate said that some Republicans — and Democrats — are reluctant to sign on because of pressure from brand-name biopharmaceutical companies, while others have expressed concern about the safety of such a complicated process.

Politics aside, David Beier, Amgen’s senior vice president for global government affairs, said the policy itself has problems.

The House and Senate bills, he said, would not take care of patient safety and ultimately would stifle innovations.

“These products are not like generic drugs. … It’s possible to construct a regulatory pathway for the approval of follow-on biologics,” but the current bills take the wrong route, Beier said.

“The regulatory pathway must be focused on patient safety, sound science and sufficient incentives for innovations,” he added.

And some lobbyists pushing for the bill wouldn’t trade Clinton’s support. “I believe this is a very bipartisan issue that is going to take some time to sort out,” said Debra Barrett, an in-house lobbyist for Teva Pharmaceuticals, a generic maker. “Sen. Clinton’s advocacy and the attention that she draws to this issue are a huge plus to moving this forward.”

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