FDA Urges Global Drug Pricing

Affordable drugs were the topic of FDA Commissioner Mark McClellan's discussion recently at the National Health Policy Conference. He recommended that generic substitution, chronic-disease management programs, and a global pricing strategy could increase access to lower-priced medicines. FDA officials want a "global solution" to containing prescription-drug prices, a plan that includes having other countries reflect US drug pricing.

"It doesn't mean other countries spending more money," Dr. McClellan said. Instead, brand name drugs should cost more in other countries and generics less, thus "increasing financial rewards for innovative drugs." He added that the pipeline of drugs in different stages of FDA approval has never been fuller.

"This century may be known as the biomed century," he said. "But millions of Americans are rightly worried that, even if these innovations come along, they won't be able to afford them."

Proponents of importing prescription drugs from Canada believe that it is a safe way to reduce drug costs. FDA officials have said, however, that the practice is illegal and dangerous. In fact, the FDA recently released the results of spot inspections of Canadian shipments in 6 US cities. The agency uncovered 1728 drugs not approved for US sale. Dr. McClellan argued that the savings are not substantial when patients factor in the cost of the "middlemen" and shipping.

"States could do aggressive generic substitution," Dr. McClellan added. He also suggested that other nations offer incentives?in the form of higher prices?to drug companies for researching and developing new drugs. For example, in Italy, generics now cost 2 times as much as branded drugs, he said.

"It's not a trade issue; it's a global health issue," Dr. McClellan stated. "If all countries pay their fair share, prices can be lower for everyone."