FDA chief: Changing generics regulations could reel in drug prices

Part of the FDA commissioner’s job is to oversee the federal regulatory watchdog as it evaluates pharmaceuticals for safety and efficacy. Most FDA chiefs have avoided the topic of drug prices, given that it isn’t a clearly-stated part of the agency’s mission

But just 2 weeks into the job, newly-confirmed FDA commish Dr. Scott Gottlieb proposed a plan, called the Drug Competition Action Plan, that he believes will help restrain the cost of prescription drugs.

As he testified before the House appropriations subcommittee that’s deciding the FDA’s 2018 fiscal budget, Gottlieb said that helping generics gain access to the market could bring down the prices for expensive brand name pharmaceuticals.

“Simply put, too many patients are priced out of the medicines they need,” Gottlieb said, 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.”

The commissioner called on the FDA to accelerate the application review process to eliminate the backlog of 2,640 applications. Nearly 1,500 of those applications have been sent back to sponsors with requests for changes.

Gottlieb also suggested that the FDA could regularly publish lists of older medicines that don’t have generic competition, to encourage generics-makers into the market.

Under current FDA standards, it’s challenging to prove equivalence to “complex” drugs, like medications administered using an inhaler. Because of this, there are a number of products that are off patent but still don’t have generic competition – including Mylan‘s (NSDQ:MYL) EpiPen. Gottlieb said the FDA could make the review process simpler in order to get generics to the market.

He also said the agency should intervene in cases in which a brand-name drugmaker is accused of using FDA rules to refuse to make a drug available to generic manufacturers.

“The FDA has an important role to play in making sure that its statutory and regulatory processes are working as intended, and not being manipulated in ways that FDA and Congress did not intend,” he said.