Martin Shkreli, Pharma Exec, Denies Trying to Game FDA Voucher System [Picture]
iotechnology-industry lightning rod Martin Shkreli is drawing fire again. The 32-year-old co-founder of the hedge fund MSMB Capital Management LLC and founder of Turing Pharmaceuticals raised the ire of just about everybody when the news broke in September that he would jack up the cost of an old drug treatment used by AIDS patients to $750 from $13.50 after Turing acquired the rights to it.
Now Shkreli is in the eye of another storm over a similar effort involving a treatment for Chagas disease, a tropical parasitic malady that is potentially fatal. After an investor group led by him acquired 70 percent of the shares of the struggling KaloBios Pharmaceuticals Inc. for a reported investment of at least $3.0 million last month, Shkreli said he’s applied to obtain a so-called priority-review voucher from the U.S. Food and Drug Administration (FDA) that could speed the agency’s approval of benznidazole, which is used to treat Chagas.
The issue raises questions about how the U.S. government promotes drug development and whether this is part of a larger problem that causes patients and their insurers to pay so much money for so many drugs. These FDA vouchers can be worth hundreds of millions of dollars when they’re acquired by one company and sold to another firm.
“The only reason for him to do this is to get the voucher and turn around and sell it,” Dr. Caryn Bern, a Chagas disease specialist at the University of California at San Francisco, told the New York Times.
The voucher system is aimed at promoting the development of drug treatments for rare conditions that pharmaceutical companies might otherwise ignore, but those vouchers can also be sold to other firms for hundreds of millions of dollars. Critics have claimed Shkreli is taking advantage of a loophole that allows the FDA to assign vouchers for drugs that already exist source.
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