FDA Pulled Into Drug Pricing Fray

While FDA historically has no authority to regulate or set drug prices, under the Trump administration it appears the agency’s role is about to expand to help the White House implement a new executive order to bring the prices Americans and taxpayers pay for prescription drugs in line with those paid by similar nations.

FDA's primary responsibility is to protect public health by ensuring the safety and efficacy of drugs, biologics, and other regulated products. Drug prices are determined by manufacturers, distributors, and retailers in the U.S., and the government generally does not intervene in this process. One exception is the Inflation Reduction Act of 2022, which allows the government to negotiate prices for certain drugs under Medicare.

In an unprecedented interview 5/12 on News Nation about the just-signed executive order, FDA commissioner Marty Makary said the pharmaceutical industry needs to level the playing field. Addressing concerns about access to drugs, Makary said the real access problem is attributed to “these crazy high prices that represent price gouging of Americans selectively while you can go to other countries and buy these same drugs much cheaper.”

Makary said that there are a “lot of incentives at the FDA to encourage companies to level the playing field and give us a good price. And so we're going to be exploring all of those incentives. We also have the option of allowing states to import drugs from other countries, and there’s a precedent for that, and that’s something that’s on the table as well."

The commissioner said the executive order is broad and addresses all drugs where there’s a significant disparity in price overseas from the U.S. “And that has been a game that’s been going on for a long time,” he said. “Everybody knows it, and so now we’re going to be using the power of negotiation. We're going to be using diplomacy. We’re asking companies to voluntarily give us the same best price in wealthy countries that they offer elsewhere. But we also are reserving the right to use the full regulatory and policy power of this administration to make it happen.”

Asked if there is an example of a certain type of drug that people could expect to see a change, Makary said the discussion on price lowering will be mainly directed at newer, on-patent drugs that have market exclusivity. “That’s where you really will see a savings, and that savings is going to be harnessed to do some amazing things in healthcare and in this country."