The Food and Drug Administration (FDA) will take action to deal with the rising cost of prescription drugs, the agency’s head said on Monday.
FDA Commissioner Scott Gottlieb said high drug prices are “a public health concern that FDA should address.”
Gottlieb said the agency will take steps to speed up the regulatory approvals of certain kinds of generic alternatives to pricey “complex” drugs. The goal is to increase competition, which could help to slow the growth or even lower the price of prescription drugs.
“[A]ny 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 in a blog post.
“If consumers are priced out of the drugs they need, that’s a public health concern that FDA should address,” he said.
Gottlieb’s actions are largely unprecedented as the FDA has mostly stayed out of the drug pricing debate. The agency has historically focused on making sure products are “safe and effective,” leaving the pricing issues to Congress.
Congressional outrage over rising prescription drug costs has been a bipartisan concern, but the parties are divided over whom to blame and solutions.
Democrats want greater price controls and want to allow certain drugs to be imported from overseas. Republicans want to increase competition in the marketplace and encourage the development of generic alternatives.
So far, no bills have passed.
During his presidential campaign, Trump railed against the pharmaceutical industry and its prices, saying they are “getting away with murder.”
In June, the Trump administration floated a draft executive order that would have cut regulations in order to speed up drug approvals or lower the price of expensive prescription drugs.
The order was never published, but experts said the policies were considered to be friendly toward the pharmaceutical industry.