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HITE OAK, Md. — The commissioner of the Food and Drug Administration, Scott Gottlieb, said a proposal to have pharmaceutical companies include drug prices in advertisements has prompted a series of questions, including exactly how consumers would benefit and whether the government can legally require the disclosures.

In an interview with STAT, Gottlieb said an agency working group would consider questions like those as it seeks to implement one of the Trump administration’s top proposals for lowering drug prices.

“Does the disclosure of the price information provide appropriate balance to the consumer — like, is the information about the cost of the drug and the accessibility of the drug important at the time that they’re seeing the advertisement, in order to provide appropriate disclosure and fair balance in the advertisement?” Gottlieb said.

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When asked, he said that “we don’t know the answer to that question.”

Of the 50-plus actions the Trump administration announced last week as part of a plan to bring down drug prices, the notion of including drug prices in direct-to-consumer ads was one of two that Health and Human Services Secretary Alex Azar specifically drew attention to in remarks following President Trump’s speech on the topic.

Gottlieb’s comments signal much work remains to be done on the buzzy policy proposal.

Gottlieb said that he was asked by HHS to “look at putting list price in advertising,” but also said  that it’s possible that a different measure of the price would be included in an advertisement instead.

“We’re going to look at what a framework would be for the disclosure of price information,” Gottlieb said. “Whether it’s either voluntary or mandatory? That’s a legal question that we need to assess,” Gottlieb said.

Gottlieb shared his thoughts on drug pricing, as well as the role and structure of the FDA, in a wide-ranging interview at the agency headquarters Thursday morning.

Some highlights:

Drug pricing around the globe

On Tuesday, Gottlieb said in an interview with CNBC that generic drugs are overpriced and branded drugs are underpriced in other countries compared to the U.S., and “that’s not a system for success in the long run.”  On Thursday, he told STAT that it would be “more equitable” if drug costs in different countries were related to the relative wealth of those countries.

“If we truly had world pricing or had tiered pricing globally, based on market segments — rich nations, medium wealth nations, poor nations — if we truly had more global pricing…you would see launch prices and global prices that reflected an average across what markets can bear rather than the very sharp price differences we see right now,” Gottlieb said.

Trump, for his part, has linked low prices abroad to high prices for Americans. In his speech last Friday, he said that “when foreign governments extort unreasonably low prices from U.S. drug makers, Americans have to pay more to subsidize the enormous cost of research and development.”

Gottlieb said that the president’s rhetoric has not negatively impacted his own relationships with drug regulators in other countries that might be the target of Trump’s vitriol.

“I can’t remember a single instance where that’s been brought up in any of my bilateral meetings with global counterparts,” Gottlieb said.

FDA’s structure

Some parts of the FDA are in the midst of a massive reorganization — the agency plans to split up some of its drug review divisions and recruit more senior leaders — but Gottlieb told STAT that the general structure for separating small molecule drugs from biologics is here to stay.

Why not combine the two centers, since biotechnology is used for more and more drugs nowadays?

“It’s an interesting question, because when it comes to small molecule drugs, I would say 80 percent…of the review is focused on the clinical portion of the review,” Gottlieb said. In contrast, for biologics, “80 percent of the review is probably focused on product issues.”

President Trump, the FDA expert

Gottlieb had nothing but praise for President Trump.

“The president in my discussions with him has a deep understanding of FDA,” Gottlieb said. “I’ve been around FDA for a while and I’ve had discussions with senior principals who are many steps removed from the agency and I will tell you, I think this president, relative to a lot of other people, has a very deep understanding of FDA, especially given that he’s president of the whole United States and not the FDA Commissioner.”

Sometimes, though, Trump still finds the need to call upon Gottlieb’s expertise. In March, Trump, who at the time was meeting with Bill Gates, called Gottlieb on speakerphone to chat about a universal flu vaccine.

Gottlieb said that this “doesn’t happen often,” but when it does, “I always pick up the call.”

Erin Mershon contributed reporting.

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