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Regulatory News | 11 January 2016 | By Michael Mezher
A group of 51 lawmakers are calling on the National Institutes of Health (NIH) to issue guidance on when "march-in rights" could be used to bypass patents on drugs developed using federal funding.
In a letter led by Rep. Lloyd Doggett (D-TX) to Department of Health and Human Services (HHS) Secretary Sylvia Burwell and NIH Director Francis Collins today, the lawmakers call on NIH to "utilize [its] existing statutory authority to respond to the soaring cost of pharmaceuticals."
In 1980, the Bayh-Dole Act was passed to allow universities, small businesses or non-profits to retain ownership of patents for inventions made with federal funding. However, the act also allows federal agencies to license a patent when "action is necessary to alleviate health and safety needs which are not being reasonably satisfied [or] available to the public on reasonable terms."
Despite having this authority for more than 35 years, NIH has never exercised its march-in rights, and has denied all five petitions calling on it to exercise those rights.
In its 2004 determination on Norvir, NIH argues that it is not in their purview to direct the prices of drugs, saying, "the extraordinary remedy of march-in is not an appropriate means of controlling prices. The issue of drug pricing has global implications and, thus, is appropriately left for Congress to address legislatively."
Today's letter calls on NIH to take a more proactive role in wielding march-in rights as a means of keeping drug prices in check. The letter argues that because of high prices, many drugs are not "available to the public on reasonable terms."
To remedy this, the letter calls on NIH to issue guidance on when march-in rights can be exercised, which the lawmakers argue would protect consumers "when wrongdoing occurs," and allow "pharmaceutical companies … to make better-informed pricing decisions."
Speaking to Focus, Aaron Kesselheim, associate professor of medicine at Harvard Medical School and coauthor of a recent study Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research?, said that issuing official guidance on march-in rights "could have a slight effect" and would suggest a "substantial change in perspective" at NIH.
This isn't the first time Congress has called on government agencies to step in and help lower drug prices in recent months. Sens. Claire McCaskill (D-MO) and Susan Collins (R-ME) sent letters to four companies about how they're pricing drugs and held a hearing on the issue. Rep. Jan Schakowsky (D-IL) also introduced a new bill that would allow Burwell to negotiate some Medicare Part D prices. And Democratic presidential candidates Hillary Clinton and Bernie Sanders unveiled proposals to stem the tide of rising prices.
Tags: March-in rights, Bayh-Dole Act, HHS, NIH, National Institutes of Health, Department of Health and Human Services