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By Debra Rosenberg
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The political campaign may be over, but the battles over prescription drugs are heating up. Last month the Food and Drug Administration drew new scrutiny after an FDA regulator told Congress that the agency was "virtually incapable of protecting America" from unsafe drugs like the arthritis medication Vioxx. But while Congress and the White House are contemplating changes in the system, the more immediate concern for most Americans is simply how to pay for the prescription drugs they need. Drug costs are "the fastest-growing part of health care," says Ron Pollack, executive director of the consumer group Families USA. The pharmaceutical industry argues that the cost of research and development for new drugs has increased dramatically. Jeff Trewhitt, a spokesman for PhRMA, the Pharmaceutical Research and Manufacturers of America, says much of the rise in overall drug costs actually comes from a dramatic increase in the volume of drugs used. "We have more medicines and better medicines for more diseases," he says. Congress and the White House are expected to tackle a number of prescription-drug issues in the coming year. On the table:
MEDICARE. The discount drug cards and $600 annual subsidies to low-income seniors are already available. Seniors will have to decide next fall whether to sign up for the full drug benefit, which takes effect in 2006. Some critics of the GOP-backed plan say the drug benefit is stingy and the law gives too much control to drug companies and insurers. Others com-plain that the overall cost of the plan--which has already ballooned from $400 billion to $576 billion over 10 years--adds to the deficit.
The biggest political debate may be over whether the federal government should be able to negotiate Medicare drug prices. The Medicare law expressly forbids that kind of bargaining. But Democrats and groups like the American Medical Association have argued it could help keep prices down. The Bush administration and congressional GOPers say government meddling amounts to price fixing and would detract from innovation. They're hoping to keep prices low through free-market competition from the private health plans that will provide the drug coverage.
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REIMPORTATION. It started with a few seniors taking day trips to Canada, where they could buy many prescription drugs at a fraction of what they cost back home. Now the notion of buying drugs from Canada has grown so popular that lawmakers in both parties have embraced it. The White House and Health Secretary Tommy Thompson have so far refused to sign on, citing concerns about whether the FDA could safely monitor the drugs' manu-facture, storage and shipping. Thompson dispatched a task force to investigate the idea--the results are expected as soon as this week. But even if the task force gives reimportation a green light, it faces hurdles in Congress. One opponent is Senate Majority Leader Bill Frist--a surgeon--who recently recounted how his health-policy director was able to buy "Canadian" drugs online that turned out to be from Asia. Even if the FDA could ensure safety, it might require an expensive new bureaucracy to do so. And it's tough to see how Canada--a nation of some 40 million--could possibly supply all the drugs that 300 million Americans need. "The math just doesn't work," says one administration official.
GENERICS. As part of the Medicare law, President George W. Bush made it somewhat easier for companies to bring cheaper generic versions of prescription drugs to market. The president believes that generics provide safe, cheaper alternatives to brand-name drugs and also foster price-lowering competition. Though PhRMA hasn't always backed generics, the industry now sees them as a better alternative than price controls or reimportation. (And they now account for more than half of the prescription-drug marketplace.)
PhRMA also highlights hundreds of patient-assistance programs that provide drugs to the needy--last year member companies gave out more than 18 million free prescriptions. Where you shop matters, too. One New York City study last year found wide price disparities for the same medications, even within the same neighborhood or the same drugstore chain. Shopping around may be simple advice, but for many Americans struggling to pay drug bills, it's a good first step.
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