How Drug-Industry Lobbyists Got Their Way on Health Care

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Waxman had pushed to shield biologics for no more than five years — the same amount of time that traditional pharmaceuticals get under the Hatch-Waxman law. President Obama proposed seven years as a compromise.

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Eshoo's successful amendment to the Energy and Commerce Committee bill would extend that to 12 years of exclusivity, as would legislation passed a few weeks earlier by the Senate Health, Education, Labor and Pensions (HELP) Committee. Then-chairman Ted Kennedy, whose state of Massachusetts is home to many biotech firms, had long supported a 12-year exclusivity period. The industry showed its gratitude last year when Amgen, one of the biggest biotech firms, donated $5 million — twice the size of the next largest donation — to a nonprofit educational institute being built in Kennedy's honor. (Watch TIME's video "Uninsured Again.")

The Federal Trade Commission (FTC), though, argued in June that giving biologics makers any period of exclusivity at all could actually stifle innovation. Biologics are so much more complex and expensive to produce than traditional drugs that the barriers to would-be "biosimilar" competitors are already high, the FTC said. Giving biologics further protection — particularly the 12 years of exclusivity that the industry wants — would merely encourage firms to tinker with what they have rather than drive them toward "new inventions to address unmet medical needs."

Most small biologics companies are still years away from seeing their first profits in this high-risk, high-return business. Their trade association, BIO, says that in the past 11 months, at least 40 of them have cut back or eliminated drug-development programs. The venture capitalists who invest in them "aren't looking to cure Parkinson's disease as much as they are looking for a return on their investments," says Greenwood. "They're just as happy to put their money into the next iPod." But increasingly, the big players in the pharmaceutical industry are moving into the biologics business themselves, either by investing in cutting-edge firms or by acquiring them. (See the most common hospital mishaps.)

Shifting Politics
That makes the politics — and the lines of political influence — a lot more difficult to sort out. Whereas the traditional pharmaceutical industry is concentrated in just a couple of states, biotech firms have sprung up just about anywhere you find a university with a research hospital, which gives them a broad political base. "I know that vote hurt me at home," says Ohio Senator Sherrod Brown, who led the unsuccessful fight against the 12-year exclusivity in the Senate HELP Committee.

Indeed, the biologics lobby has become one of K Street's most powerful players. Working largely through BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA), it has funded an extensive network that includes not only lobbyists but also think-tank experts and advocacy groups. "You can't get on the phone with someone who isn't getting paid," says an economist who has studied the biologics issue with funding from a drug company. "They give money to everyone and anyone."

That means it can be hard to find a truly independent viewpoint, though it often requires deep digging into the finances of advocacy groups to discover their ties. In July, one calling itself the National Health Council wrote letters to members of Congress "on behalf of 133 million Americans" asking for a minimum of 10 years of data exclusivity. The group boasts a membership that includes 50 of the nation's largest patient-advocacy groups, including the American Cancer Society, Easter Seals and the National Kidney Foundation. But its board of directors reads like a Who's Who of top pharmaceutical executives from Amgen, Pfizer, Novartis and Bristol Myers Squibb. Its 2007 tax filings show that almost half its $2.3 million budget came from PhRMA and drug companies.

Similarly, on Oct. 19, PhRMA put out a statement calling for a "fair period of data protection" of 12 years at a "bare minimum." To defend its position, the group cited Duke University economist Henry Grabowski, whose work it has funded, and two patient groups. One, called RetireSafe, receives regular infusions of "general operating support" from Pfizer and operates out of a small Washington law-firm office. It has been blitzing Capitol Hill with letters arguing that guaranteeing biologics makers fewer than 12 years of exclusivity in the use of their data could cost lives. The other group, the Alliance of Aging Research, is also run by the drug industry. Its chairman is the managing partner of Foxkiser, a drug-company consultant, and its vice chairman is with Novartis.

Among the biologics industry's most high-profile advocates has been former Democratic National Committee chairman Howard Dean, who is consulting for a law firm that has a deep roster of biologics clients. In July he wrote an Op-Ed in the Hill newspaper arguing for a "commonsense and fair approach" to give biologics companies at least 12 years of exclusivity. ("I wouldn't do this if I didn't believe it," Dean, a physician, said in an interview.) His former campaign manager Joe Trippi echoed Dean's views on a Huffington Post blog without disclosing that he had been paid by BIO to create two Web campaigns. (He also says his views predated his paycheck.)

The other side has resources of its own. The biggest generic-drug company, Teva Pharmaceuticals, has spent more than $2 million on lobbying and also sponsored academic work on the issue, aiming to disprove Duke's Grabowski. Generic-drug manufacturers are allied with such powerful organizations as AARP, labor unions, insurance companies, health-maintenance organizations and health-reform advocacy groups. There will be fights on the House and Senate floors and ultimately a House-Senate conference committee, on which Waxman will be a key voice. "The war is not over," he has warned. "If you know me at all, you know that I don't give up that easily."

How it is resolved — in favor of protecting the biotech industry or opening up the market to generics — may say a lot about which interest groups will ultimately reap the windfall of the big-stakes battle in Washington. What it means for consumers is somewhat murkier: Will a miracle cure be there when you need one? And if it is, will you be able to afford it? Those are questions that hinge on whether the rest of us can trust Congress to find proper balance between competition and innovation.

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