The US invests more than $32 billion each year in drug and biomedical research. This major public investment in drug research empowers the government to make drugs affordable under the Bayh-Dole Act of 1980. But, even when drug companies price critical drugs at staggeringly high prices, the government has never used this authority. Why doesn’t the federal government ensure reasonable prices for drugs developed with public funds — an appropriate return on the public’s investment?
According to Peter Arno and Michael H Davis, Bayh-Dole revises the US patent law so that the federal government can ensure new drugs developed in part or whole with federal dollars are priced reasonably. Put differently, when federal dollars support research on a new drug, the drug manufacturer is supposed to price the drug reasonably. If the manufacturer does not, the federal government has the right to authorize another manufacturer to license the drug and sell it at a reasonable price.
So, even when there’s a patent on a drug developed with federal money, the US has the right to a royalty-free license. As Alfred Engelberg and Aaron Kesselheim write in the June 2016 issue of Nature Medicine, Sen. Birch Bayh explained that the goal was for the US to “use for itself and the public good inventions arising out of research that the Federal Government helps to support” while seeing that “the inventions receive their full potential in the marketplace.” But, the government’s authority under the law can be interpreted broadly or narrowly.
To date, the government has interpreted the Bayh-Dole law narrowly. According to Peter Arno, “the federal government essentially has argued time and again that if a drug company sells the new drug in the US, it has met the criteria for Bayh-Dole; it completely misconstrues the part of Bayh-Dole that calls for making the drug available to the public on “reasonable terms.” Based on a review of Congressional testimony before passage of the Bayh-Dole Act, “reasonable terms” means reasonable prices.”
Arno further explains that “both Democratic and Republican administrations have, for more than 30 years, refused to enforce this provision of Bayh-Dole. At the same time, counting on the lack of government interest in enforcement, the drug companies have been cavalier in even recording the Bayh-Dole legend in their patent applications (a requirement) — often leaving them out altogether, making it harder to track Bayh-Dole inventions.”
Earlier this year, 50 members of Congress formally requested that the Department of Health and Human Services (HHS) and the National Institutes of Health use their authority to enforce Bayh-Dole’s reasonable pricing provisions to help bring down the price of drugs. In a related response to a high-priced drug (Xtandi), HHS argued that the need was not there since there was an adequate supply of the drug.
Why should the drug industry be the exclusive financial beneficiary of research that the public helps fund? The public should benefit as well. Instead, federal policy is driving up drug prices. If you think it’s time the federal government took action to bring down the price of drugs, sign this letter from Social Security Works to the next president of the United States requesting the president take executive action to rein in drug prices.
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