By Sy Mukherjee
September 11, 2018

Hello, readers—This is Sy.

Here’s something you don’t see every day: The Commissioner of the Food and Drug Administration (FDA) took a very public (and harsh) stance on drug price gouging in response to a story published by the Financial Times‘ David Crow.

The background: Nostrum Laboratories CEO Nirmal Mulye attempted to use a Martin Shkreli-style excuse (Mulye literally defended the infamous drug-price-hiker-turned-convicted-felon) in a gambit to justify sharply raising an antibiotic mixture’s price as a matter of defending shareholder value. “I think it is a moral requirement to make money when you can . . . to sell the product for the highest price,” Mulye told FT, adding that he believes the FDA is “incompetent and corrupt” for levying certain fees on drug makers.

FDA Commissioner Scott Gottlieb had a few things to say about that on social media. Here are some choice quotes:

1/2 Regarding story today ; there’s no moral imperative to price gouge and take advantage of patients. FDA will continue to promote competition so speculators and those with no regard to public health consequences can’t take advantage of patients who need medicine

2/2 There are other suppliers of this product and, by its own admission in , the company in question isn’t actively marketing their formulation. Their excessive price, detached from market principles, exists only on a list and should remain there in a competitive marketplace

Gottlieb, who has moved (at times controversially) to ease the drug approval process, particularly for generics, in a bid to lower pharmaceutical list prices, went on to promise further action on the matter as a direct consequence of the FT story. “We’ll release more data soon but this is a competitive drug category, it’s not on our shortage list, and the brand product at issue isn’t even marketed. It’s a list price that exists only on a list. As for the CEO, those who market medical products should show regard for patients,” he said in another tweet.

As for whether or not drug companies at large are actually committed to holding down prices? That’s a more complicated story. Several major biopharmaceutical companies have pledged to, at least temporarily, hold off on drug price increases in the wake of criticism from President Donald Trump’s administration. But the net effect for consumers, given all the various middlemen and general opacity in the drug supply chain, is a lot more difficult to assess.

Read on for the day’s news.

Sy Mukherjee


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