The Obama administration is rejecting a request from a group of House Democrats to open the door to a far-reaching response against high drug prices.
Health and Human Services (HHS) Secretary Sylvia Mathews Burwell sent a letter to Rep. Lloyd Doggett (D-Texas), dated March 2, that declines his request for the department to issue guidance on the use of “march-in rights” to break drug patents when prices are too high.
Her letter suggests Burwell isn't willing to be as aggressive in using this tactic against high-drug prices as some House Democrats want.
In January, Doggett led a group of more than 50 House Democrats in writing to HHS requesting that the department issue guidance on the situations in which “march-in rights” would apply.
Under a 1980 law, when federally-funded research was involved in creating a new drug, HHS can assert “march-in rights” to break a drug patent when the drug is not “available to the public on reasonable terms,” a definition the lawmakers argued could be used to fight high drug prices.
The lawmakers say that simply by issuing guidance on the use of the “march-in” tactic, HHS would be sending a warning to drug companies about their prices.
But Burwell’s letter declines to issue this guidance, which would have come from the National Institutes of Health (NIH).
“After consulting with the NIH, we believe the statutory criteria are sufficiently clear and additional guidance is not needed,” Burwell wrote.
Still, the administration is not completely ruling out exercising march-in rights down the road, with Burwell writing that the department is “prepared to use its authority when presented with a case where the statutory criteria are met.”
She noted, though, that the power is “strictly limited” and its' use was rejected by the NIH after past requests in 2004 and 2013.
Doggett said in a response Monday that his request was “clearly justified” to “discourage widespread price gouging.”
Still, he added that he is “pleased that the Administration is prepared to use existing authority on a case-by-case basis to address this problem.”
High-drug prices have been in the spotlight recently and a prominent topic on the presidential campaign trail.
The administration is expected to take some actions around drug prices, even if they are not as far-reaching as march-in rights.