There is a Law: Drugs Don't Have to Cost So Much

". . . It is called the Bayh-Dole Act. Unfortunately, no one is enforcing it.

"Bayh-Dole is a provision of US patent law that states that practically any new drug invented wholly or in part with federal funds will be made available to the public at a reasonable price. If it isn't, the government can . . . license it to third parties that will make the drug available at a reasonable cost.

"The idea behind Bayh-Dole is to protect taxpayers' investment in drug research and development. After all, the American public pumps more than $20 billion a year in taxpayers funds into health-related research and development, making it the single largest investor in the pharmaceutical industry. . . .

"Consider cancer research, for example. As of 1997, 54 of 84 anti-cancer drugs approved by the Food and Drug Administration were the products of federal funding. The percentage is even higher with respect to AIDS drugs developed with federal funds. . . .

"Meanwhile, prescription drug costs continue to soar at a rate of 19 percent per year. We've already paid for the cost of research. Why, then, aren't we seeing lower drug prices?

". . . Although Bayh-Dole has been in place for 20 years, the government has never enforced it -- not even once. . . .

"Why is the federal government such an irresponsible investor of public funds? First, the government agencies responsible for implementing Bayh-Dole either do not understand the law or are reluctant to exercise their responsibilities. In particular, the NIH prefers to avoid pricing issues. . . . Some of NIH's repeated public statements over the years indicate an astonishing and continuing ignorance of the Bayh-Dole provisions.

"Second, there has been no leadership on this issue. Since its enactment, Bayh-Dole has never been publicly discussed by any administration. . . . The recent stem-cell patents came from government research . . . but the government hasn't even insisted that they be subject to the law. Instead, the Bush administration used its Bayh-Dole leverage . . . for short-term political goals, getting the patent owners to agree to antiabortion restrictions on stem cells in exchange for dropping the rights to intervene.

"Third, the drug companies have successfully cast Bayh-Dole as an anticompetitive price-control measure that they claim will strangle new research. . . . But Bayh-Dole is not about price control. It is about ensuring that pharmaceutical manufacturers live up to their bargain with the public when they accept the public's money. . . .

"All Americans deserve relief from the high costs of prescription drugs. The federal government has the means to help them without spending another dime of taxpayer money. Bayh-Dole should be enforced."

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