The Obama administration won’t give exclusivity rights on high-priced drugs to competitors, rejecting a request from more than 50 Democrats.
The administration declined to use a power called “march-in rights.” It lets a federal agency that funded private research that results in a new drug patent force a company to extend that patent exclusivity to another company.
Rep. Lloyd Doggett, D-Texas, led more than 50 lawmakers in a letter to the Department of Health and Human Services to exercise “march-in rights” to help reduce high prices on drugs.
“When drugs are developed with taxpayer funds, the government can and should act to bring relief from out-of-control drug pricing,” Doggett said in January when the letter was drafted.
But HHS Secretary Sylvia Burwell balked at using such a power first granted in a 1980 law, according to a March 2 letter to Doggett.
“This right is strictly limited and can only be exercised if the agency conducts an investigation and determines that specific criteria are met, such as alleviating health or safety needs or when effective steps are not being taken to achieve practical application of the inventions,” Burwell said.
She said the National Institutes of Health considered using march-in authority in 2004 for the HIV drug Norvir and the eye drug Xalatan and in 2013 for Norvir again. After an investigation into the products, the NIH determined that march-in rights weren’t appropriate and didn’t do it.
Since 1980, the NIH hasn’t approved any use of march-in rights related to high drug prices, according to an investigation published in December in the journal Milbank Quarterly.
The push for using march-in authority is the latest effort by Democrats to address high drug prices, which include giving Medicare the power to negotiate for lower prices.
