FDA chief becomes point man on drug prices

Scott Gottlieb, head of the Food and Drug Administration (FDA), has emerged as a key figure in the Trump administration’s push to lower the cost of prescription drugs.

Gottlieb has moved to the front lines of the drug pricing fight, criticizing brand-name drug manufacturers he says are trying to block competition from getting to market.

“We know that gaming goes on all the time,” Gottlieb told The Hill in a wide-ranging phone interview. “If [companies] have an opportunity to use the existing rules in ways to impede the public health goals we seek, we see them doing it. I don’t think that’s very public-health-minded. I think it’s corrosive to the overall system.”

{mosads}President Trump has pledged to take action to lower drug costs. During his State of the Union speech, he said one of his top priorities is “fixing the injustice of high drug prices.”

Trump’s tough talk on drug manufacturers dates back to the 2016 presidential campaign, when he famously blasted the pharmaceutical industry as “getting away with murder.” He backed allowing Medicare to negotiate directly with drug companies and endorsed expanding importation of cheaper medicine.

Now in office, Trump has delegated most of the drug pricing efforts to Gottlieb’s FDA — and in a departure from traditional agency practice, the commissioner is tackling the issue head-on.

Last fall, Gottlieb wrote in a public blog posting that high drug prices are “a public health concern that FDA should address.” In a speech, he said he wanted to “end the shenanigans” that interfere with competition.  

The FDA has historically stayed out of the drug pricing debate, instead working to make sure products are “safe and effective.”

But Gottlieb says the pricing issue fits with the FDA’s mission. He says unleashing free market forces is the key to lowering drug prices and has made it a priority to speed up the regulatory approvals of generic alternatives to brand-name drugs. He has also sought to clear out the agency’s backlog of generic drug applications.

“We’ve tried to find ways to facilitate new generic drug entry, especially in places where we think there are inappropriate obstacles being put by branded companies to frustrate the ability of generics to come to market,” Gottlieb told The Hill.

Gottlieb acknowledged the difficulty in trying to police drug companies that exploit legal loopholes.

“To some extent, we are playing whack-a-mole, but we are whacking a lot of moles right now, and we’re putting out individual guidances that relate to individual abuses,” Gottlieb said.

This is Gottlieb’s second stint at FDA. He served as a deputy FDA commissioner under former President George W. Bush before leaving the agency in 2007.

After he left the agency, Gottlieb served on the boards of pharmaceutical companies, worked as a venture capitalist and was a resident fellow at the American Enterprise Institute, a conservative-leaning think tank.

During his confirmation process, congressional Democrats and outside groups sounded the alarm about Gottlieb’s industry connections, warning they pose major conflicts of interest. He had investments in 20 different health-care companies that made products regulated by the agency.

“The extent of Dr. Gottlieb’s entanglements with the industries he will be charged with overseeing are unprecedented,” Sen. Patty Murray (D-Wash.) said after Gottlieb appeared before the Senate Health Committee in April.

Most Democrats opposed Gottlieb’s nomination; he was confirmed 57-42.

Gottlieb is the only FDA commissioner who worked in the pharmaceutical industry prior to being nominated; the others have mainly come from public health or academia.

His predecessor, Robert Califf, was scrutinized by some Democratic senators because he ran a research institute that received a majority of its funding from the industry and had worked as a pharmaceutical industry consultant. But he did not have investments in drug companies or sit on corporate boards.

John Taylor, a former FDA official who worked with Gottlieb in the Bush administration, said he understands the criticism but believes industry experience should not disqualify people from serving at the FDA.

“An important part of [ensuring the FDA’s] credibility is to have safeguards in place to try and prevent conflicts of interest from occurring,” said Taylor, who is now a consultant at Greenleaf Health.

Taylor said he thinks working in the private sector gives Gottlieb a broader perspective on how industry will be affected by his decisions.

“Knowing how people operate helps inform, but it doesn’t automatically skew, your decisions. Scott has certainly done things that anger his former sector,” Taylor said. “I’m a Democrat and I know some of my Democratic colleagues are pleasantly surprised [by what he’s done in office].”

Broadly speaking, experts and activists said they approve of Gottlieb’s tenure so far.

David Mitchell, president and founder of the group Patients for Affordable Drugs, called Gottlieb a “bright spot” in the administration.

“Scott Gottlieb cannot wave a magic wand and change policies and laws, but he can address the areas that need to change,” Mitchell said. “I believe he has the interests of patients at heart.”

Gottlieb acknowledged in his interview with The Hill that his efforts on drug prices haven’t been flashy, and said he understands that outsiders want him to do more.

But Gottlieb pushed back on the idea that the FDA should start considering the value of the drugs it approves. The agency has been criticized for approving certain cancer drugs with exorbitant price tags that critics say provide little value to patients.

“We’re obviously not looking at economics or even economic value as a component of how we’re making regulatory decisions; that’s up to the discretion of payers, providers and patients,” Gottlieb said.

Gottlieb, who is a cancer survivor, said measuring the value of a drug is difficult, as even a treatment that adds only a couple months to a cancer patient’s life is important to that patient.

“I don’t think we should dismiss even incremental improvements in the study of terminal illness,” Gottlieb said.

Tags Donald Trump drug costs FDA Patty Murray

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