Five years after Martin Shkreli rose to infamy for acquiring the toxoplasmosis treatment Daraprim from Impax Laboratories for $55 million and then jacking the price by 5,000%, the U.S. FDA approved the first generic for the medication.
Five years after Martin Shkreli rose to infamy for acquiring the toxoplasmosis treatment Daraprim from Impax Laboratories for $55 million and then jacking the price by 5,000%, the U.S. Food and Drug Administration (FDA) approved the first generic for the medication.
The FDA gave the green light to New York-based Cerovene Inc.’s pyrimethamine for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide. Toxoplasmosis is an infection caused by a parasite called Toxoplasma gondii that can cause damage to the brain, eyes or other organs. More than 60 million men, women, and children in the U.S. carry the parasite, but most do not show symptoms due to a health immune system. However, for those with compromised immune systems, including cancer patients, HIV patients and more, are at risk of severe infection. Toxoplasmosis is considered to be the leading cause of death attributed to foodborne illness in the United States.
The approval of the new generic comes a little more than a month after the U.S. Federal Trade Commission filed a complaint against Vyera Pharmaceuticals (previously Turing Pharmaceuticals) alleging a scheme to prevent generic competition for Daraprim. According to the FTC complaint, Turing “illegally restrained trade through restrictive distribution agreements that ensured that would-be generic entrants could not buy samples of Daraprim” that could be used in the process of trying to develop a generic. Turing also prevented competitors from accessing a critical ingredient used to manufacture Daraprim.
FDA Commissioner Stephen Hahn said the regulatory agency has a “longstanding commitment” to increasing competition in the drug markets, particularly where there are limited or no generic alternatives, such as Daraprim, a drug that has been on the market for nearly 70 years. He said the approval of the Daraprim generic is important for the patient populations that are susceptible to toxoplasmosis and provides more treatment options.
“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,” Hahn said in a statement. “Empowering patients and promoting choice and competition are top priorities for the FDA. These important efforts include improving access to safe, effective and high-quality generic medications.”
Hahn went on to add that “gaming” techniques are not uncommon when it comes to delaying generic competition to branded medication. An example of the kind of gaming that can occur is when brand-name drug manufacturers attempt to prevent potential generic applicants from obtaining samples of certain medicines necessary to support approval of a generic drug application, the FDA noted in its announcement. In order to improve transparency about gaming issues and a lack of generic alternative, the FDA has posted a list identifying drugs it has received an inquiry about regarding limited distribution. Daraprim has been on the list, the agency said.
When Shkreli’s Turing Pharmaceuticals acquired Daraprim, the cost of a single pill was about $13.50. Turing increased the price to $750 per tablet, which drastically raises the cost of treatment for patients. Shkreli defended the price increase of the drug and at one point lamented not raising the price even higher.
Shkreli remains in federal prison in Pennsylvania following his 2017 conviction on two charges of securities fraud and one charge of conspiracy to commit conspiracy fraud – charges not related to the 5,000% price hike on Daraprim. Last year Shkreli attempted to overturn his conviction by appealing his case to the U.S. Supreme Court. The high court refused to hear his case. He is eligible for release in 2023.
