Last month, a group of lawmakers urged the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS) to take "extraordinary" action to fight rising drug prices. HHS Secretary Sylvia Burwell responded this week that her agency got the lawmakers' message and is considering rolling out new guidelines to counter skyrocketing prices.
Burwell's response was to Rep. Lloyd Doggett (D-TX), who at a recent Ways and Means Committee hearing asked Burwell whether the letter he and more than 50 other House Democrats sent to the agency in January is getting her "thorough consideration."
Burwell assured him it was.
"Your letter we have received, thank you, and we are continuing to try and pursue every administrative option," Burwell said, as quoted by The Hill. "We've proposed legislative and statutory changes as part of the budget, but are looking at a wide array, of which we welcome your letter and your suggestions," Burwell said.Rep. Lloyd Doggett (D-TX)
The January letter from Doggett and his colleagues asked HHS to issue guidelines for "march-in rights" to address "price gouging" by pharma companies. March-in-rights give the agency the power to skirt patent protections for pricey meds developed with federal funding, effectively opening them up to generic competition.
HHS has never used this tactic since the law was enacted in 1980, contending that it is an "extraordinary remedy" that should only be rolled out in extreme situations.
The NIH "in 35 years has never agreed with a request for march-in rights, particularly in the context of high drug prices," Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, told FiercePharma last month. And some argue that companies are already doing their due diligence by making patent information available.
Still, getting the NIH to act on march-in rights could send an "important signal" to the industry, Kesselheim said. "These are important issues that patients are struggling with. There may be some symbolic importance to more attention to this area."
Congressional reps contend that the recent price hikes, some of which have run to 5,000%, constitute immediate grounds for action by the agency. "Too many families and providers are facing an extraordinary challenge from unreasonably priced pharmaceuticals" and "too many drugs are not 'available to the public on reasonable terms," the lawmakers said in their letter.
- read The Hill story