The FDA plans to tackle rising drug prices, according to the regulatory watchdog’s commissioner, Dr. Scott Gottlieb.
Taking action to regulate the cost of prescription medicines would belargely unprecedented for the agency, which usually sticks to deciding whether a drug is safe and effective.
But in a blog post this week, Gottlieb described high drug costs as “a public health concern that FDA should address.”
Specifically, the FDA plans to accelerate the approval of generic alternatives to costly drugs, in the hopes of boosting competition and pushing down prices.
“Any steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices,” Gottlieb said.
Traditional, the debate over drug prices has lived in the domain of Congress. Although both parties agree that rising drug prices are a problem, Democrats tend to fight for price controls and drug importation while Republicans push for increased competition and generics.
Now-president Donald Trump waded into the issue of drug pricing during his campaign, saying that drug companies are “getting away with murder” in regards to what they charge the government.
Earlier this year, just two weeks into the job, Gottlieb proposed the Drug Competition Action Plan and called on the FDA to speed up its application review process. At the time, the agency’s backlog included 2,640 applications. Nearly 1,500 of them were sent back to sponsors with requests for changes.
Gottlieb also testified before the House appropriations subcommittee that the FDA could regularly publish lists of older medicines that don’t have generic competition, to encourage generics-makers into the market.
“Simply put, too many patients are priced out of the medicines they need,” Gottlieb told the members of the committee, according to The Wall Street Journal. “While the FDA does not have a direct role in drug pricing, we can take steps to facilitate entry of lower-cost alternatives to the market, and increase competition.”