The FDA can’t regulate drug prices, but is making an effort to prevent drug monopolies after Martin Shkreli’s action to hike Daraprim to $750 per pill.
When Turing Pharmaceuticals CEO Martin Shkreli increased the cost of Daraprim, a powerful antiparasitic drug, from $13.50 to $750 per pill, he quickly gained the kind of notoriety usually reserved for comic book villains.
Daraprim was the only drug available to treat toxoplasmosis, a disease caused by Toxoplasma gondii, a parasite that attacks individuals with weakened immune systems. The disease is most commonly seen in patients with AIDS, although it has been found in those undergoing chemotherapy. When left untreated toxoplasmosis is usually fatal.
Shkreli’s smug countenance was plastered about the Internet. The term “pharma bro” entered the cultural lexicon, and the media had a make-a-point-about-the pharmaceutical-industry field day.
Shkreli was referred to as “the face of unapologetic profiteering from the suffering of humans,” “the perfect and very hate-able combination of arrogance, youth, and avarice,” and “the most hated man in America.”
But Johns Hopkins professor of medicine Jeremy Greene, writing for Slate, looked past the immediate outrage, dubbing Shkreli “an unlikely therapeutic reformer.”
Turing exploited a government loophole that allows pharmaceutical companies to charge whatever price they want for drugs with no alternative or generic formulation.
He hasn’t been the only one to use the system to boost drug prices.
On Monday, Reuters posted an exclusive report on price increases on commonly used drugs in the United States over the past five years. The news service revealed that prices on four of the nation’s 10 most widely used drugs jumped more than 100 percent during that period. The other six drugs rose in price by more than 50 percent.
However, it was Shkreli’s actions that drew attention to a need for competition in the pharmaceutical marketplace.
Less than a year after Shkreli’s exercise in price gouging and subsequent arrest for securities fraud, the Food and Drug Administration (FDA) has responded by expediting the approval process for medications that could be used as alternatives to drugs when there is only one approved treatment, such as in the case of Daraprim.
Keith Flanagan, director of the Office of Generic Drug Policy at the FDA’s Center for Drug Evaluation and Research, described the new process for abbreviated new drug applications (ANDAs) as being “like an express lane at the supermarket.”
The recent change could speed up the approval process for as many as 125 new drugs.
Under the policy, ANDA submissions must be for drugs that only have one formulation currently approved by the FDA. They also can’t have any blocking patents or exclusives.
The new policy to green-light generic competitors to what the industry refers to as “sole-source” products is just one of several recent efforts by the FDA to prevent the kind of profiteering Turing employed.
“We hired new staff, reorganized our office, enhanced our business processes, and modernized our information systems to improve the speed and predictability of the ANDA review process,” Flanagan told Healthline via email. “Beginning in October 2016, an incoming ANDA will be reviewed within 10 months, and public health priorities such as submissions for sole source products will be further expedited.”
Currently, the FDA has seven additional drug categories that warrant expedited review.
These include drugs that are considered “first generics,” or new generic versions of brand-only formulations, as well as drugs that are needed to support public health emergencies, drug shortages, or special programs like the President’s Emergency Plan for AIDS relief.
The FDA has no say in setting the cost of Daraprim or other potentially lifesaving medications.
Although Shkreli recently used his Fifth Amendment rights to avoid testifying before Congress, Turing never lowered the cost of Daraprim. A compounded alternative to the drug made by Imprimis pharmaceuticals sells for $1 per pill.
The FDA can work to prevent price gouging in the future, but it’s clear that in some cases, and in more than just Turing’s example, the damage has already been done.