How Drug-Industry Lobbyists Got Their Way on Health Care

[slipslidingaway]

Full article.
http://www.time.com/time/politics/article/0,8599,193159...

Thanks to malaise for posting this article in her thread.
http://www.democraticunderground.com/discuss/duboard.ph...

By Karen Tumulty and Michael Scherer Thursday, Oct. 22, 2009

"...The Generic Nudge

The question before Waxman's committee last summer was this: How many years of monopoly protection should be afforded to biotechnology drugs, known as biologics, before cheaper alternatives are allowed on the market? These miraculous drugs — which differ from traditional, chemical-based pharmaceuticals because they are derived from living matter — are widely regarded as the future of the pharmaceutical industry and, indeed, of medicine itself. While only 20% of drugs on the market today are biologics, it is expected that, with 633 biotechnology medicines in development last year for more than 100 diseases, half the new drugs approved in 2015 will be. Biologics average more than 20 times the cost of traditional drugs: treating breast cancer with a year's worth of the biologic Herceptin can cost $48,000; Remicade, for rheumatoid arthritis, can cost $20,000 annually. For other, rarer diseases, the price of biologic treatments can be as high as $200,000 a year...


...As policymakers look for ways to control health-care costs, the price of biologics is drawing more and more scrutiny. The obvious model for bringing in competition is a 1984 law that Waxman wrote with Republican Senator Orrin Hatch. It lowered the regulatory obstacles that prevented generic drugs from making their way to market. At the time, it was expected that fast-tracking the approval of "bioequivalent" drugs would bring down medical costs by $1 billion a year. But with generics now accounting for more than 70% of prescriptions dispensed in the U.S., "the actual savings have exceeded our wildest expectations," Waxman said in a Sept. 18 speech before the Generic Pharmaceutical Association. "In the last decade alone, generic drugs have saved consumers, businesses and state and federal governments $734 billion."


...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."


...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.)

...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."