So ends the seeming monopoly that Turing Pharmaceuticals has over the market for drugs to treat toxoplasmosis.
According to The San Diego Union-Tribune, Imprimis Pharmaceuticals, a San Diego-based biomedical company that specializes in generic drugs, plans to compete against other companies who sell generics at prices far above their cost. Most notably, this includes an alternative to Daraprim, a drug used to treat toxoplasmosis, a disease which affects people with weakened immune systems, such as AIDS patients and people who undergo chemotherapy to treat cancer.
Turing Pharmaceuticals made headlines last month — and its CEO, Martin Shkreli, became reviled in some circles — when it raised the cost of Daraprim from $13.50 to $750 per capsule. On Thursday, Imprimis announced it would begin offering an alternative to Daraprim for what amounts to $1 per pill. Imprimis’ alternative combines pyrimethamine with another generic drug, leucovorin, a form of folic acid used for treating chemotherapy patients, that is expected to cut down on some of pyrimethamine’s toxic effects on the body.
Shkreli, Turing’s CEO, initially defended the price increase, arguing it is necessary for his company to stay in business due to the high cost of distribution, manufacturing and costs associated with FDA compliance. He argued that half of his company’s revenue is spent on research and development to help find a more effective drug for treating toxoplasmosis that has fewer toxic side effects. Shkreli also has argued that the price increase puts Daraprim more in line with other generics that are used to treat rare diseases such as toxoplasmosis.
After receiving blowback from some in the medical community and from politicians, including Democratic presidential candidates Hillary Rodham Clinton and Bernie Sanders, Shkreli announced that his company would lower the price of Daraprim. But so far, no price reduction has been evident.
Due to calls from the LGBT community, particularly the Human Rights Campaign (HRC), New York Attorney General Eric Schneiderman (D) began investigating whether Turing had violated antitrust laws by limiting distribution of a drug that is essential to the lives of medically vulnerable people. HRC has called for members of Congress to undertake a similar investigation. The LGBT rights organization has also been circulating an open letter, signed by 151 organizations, urging Shkreli to lower the price of Daraprim and undertake other actions to ensure that low-income and medically vulnerable people are able to access and afford the drug.
Mark Baum, the CEO of Imprimis, told the Union-Tribune in an interview that his company is providing a market-based answer to exorbitant drug pricing. But Baum also acknowledged there are limitations. First, the formulation combining pyrimethamine with leucovorin is not FDA-approved, and can only be sold through a doctors’ prescription to a specific individual. The ingredients themselves are FDA-approved and the company’s compounding operations are FDA-inspected, but filing for FDA approval of the compound would take years and cost millions of dollars. By not filing for FDA approval, Baum argues that Imprimis can keep prices down and still make a significant profit. Baum expects to provide similar alternatives to other generics being sold at exorbitant prices.
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