The FDA OKs generic Daraprim, the Martin Shkreli therapy that triggered an unending tempest over drug pricing
The FDA posted a new generic drug approval Friday afternoon, and this one arrived with a little extra relish added to the customary pronouncement.
The agency has given Cerovene the green light to sell generic Daraprim, Martin Shkreli’s treatment for toxoplasmosis that detonated a world class brouhaha over drug pricing that has tainted the industry. Shkreli no sooner acquired the old, once cheap drug than he instantly raised the price by more than 5,000%, something that the general public — and a big segment of the biopharma industry — was profoundly appalled by.
It’s taken more than 4 years for a generic to come along, and given the way drug pricing works in the U.S., there’s a good chance that real price relief may still be a long way off.
Shkreli, always ready to play the Joker in every pharma biopic, blasted back against the public scorn that he stirred, up until he was sentenced to 7 years for defrauding investors in the hedge funds he had driven into a brick wall before he turned to biotech — following the path of buying drugs and hiking the price.
Lawmakers put him in the spotlight, but there was no shaming Shkreli. The price stayed high, and the agency eventually wound up using the case to craft new rules that would help prevent Shkreli wannabes from following in his footsteps.
“Through the FDA’s Drug Competition Action Plan, we’ve worked to remove barriers in generic drug development by not only taking actions that improve the efficiency of the development, review and approval of generic drugs, but also by closing loopholes that allow brand-name drug companies to ‘game’ the rules in ways that delay generic competition that Congress intended,” FDA commish Stephen Hahn said in a prepared statement.
According to a recent federal lawsuit brought by the FTC and the state of New York, Shkreli engaged in just such behavior, cooking up “an elaborate anticompetitive scheme to preserve a monopoly” for Daraprim. The alleged offenses ranged from keeping samples out of reach for generic drugmakers to blocking access to sales revenue.
There’s no immediate word, though, on what Cerovene plans to charge for the drug. And typically, it takes several generic drug rivals to force the price down sharply. No matter what happens to Daraprim, though, the drug pricing debate, and the fallout that Daraprim helped create, has become a fixture of the US political scene and the 2020 election cycle. And some of these candidates are after much bigger fish than the imprisoned Shkreli.