Trying to make new drugs "affordable, safe, and innovative" is a "global crisis," said Mark McClellan, commissioner of the US Food and Drug Administration, in a speech to the first international colloquium on generic medicine in Cancun, Mexico. He said the United States was paying too high a price for developing new drugs and called for other rich countries to share development costs, perhaps in proportion to their national income.
Developing a new drug costs more than $800m (£480m; €690m), Dr McClellan said. As countries tighten their price regulations, drug companies might reduce investment in some products and shift to "lifestyle drugs," such as drugs for erectile dysfunction and other products whose price won't be regulated.
"If we do not find better ways to share the burden of developing new drugs and biologics, all of us will suffer. The benefits of these treatments are global," he said, adding that a global solution was needed to pay for them. The value of drug patents is increasingly limited by strict government price controls.
"Some of the world's richest nations are driving the world's hardest bargains," Dr McClellan said, arguing that these nations are paying for the production costs of drugs that have already been developed, not the costs of developing them.
In the United States the cost of prescription drugs is a growing political issue. Many elderly people, whose health often depends on prescription drugs, don't have insurance cover to pay for them. Many have resorted to importing prescription drugs from Canada and Mexico, where they are cheaper. The state of Illinois is investigating whether it can save money by letting health plans, state employees, and retired people import drugs from Canada (27 September, p 700). The city of Springfield, Massachusetts, started a voluntary import programme for city workers and retired people.
Price controls hurt innovation, said Mark Grayson, deputy vice president of the US Pharmaceutical Research and Manufacturers of American. "They don't help patients get access to innovations sooner. [Foreign] governments are free riding, not paying their fair share [of US] development costs."
In London, Joe Collier, professor of medicines policy at St George's Hospital Medical School, calls the situation "reverse colonialism." Other countries have filled the coffers of the rich West, and now the West should pay for providing medicines to poorer countries, he says.
"Drug companies charge what they can get away with," Professor Collier said. "No one knows the truth [of drug development costs]—$800m, or $200m?"
Dr McClellan has also called for greater use of generic drugs. Generic drugs account for most prescriptions in the United States, 40% or less in Canada, and even less in Europe—only 10% in France, for example.
The text of Dr McClellan's speech is at www.fda.gov/oc/speeches/2003/genericdrug0925.html