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Health Law and Compliance

Our ACHT Fellow, Dr. Marion Mass, was quoted in an
By David H Levien
Posted on 4/24/2020 1:46 PM
article in Vanity Fair Our ACHT Fellow, Dr. Marion Mass, was quoted in an article in Vanity Fair entitled “I Take That as a Threat”: Big Pharma Is Meddling in the Race for a COVID-19 Treatment” BY DIANA FALZONE.

To quote Marion, “The Orphan Drug Act, which Congress passed in 1983, uses financial incentives to encourage the development of drugs that treat rare diseases. Among other things, said Dr. Marion Mass, a Philadelphia-based pediatrician and cofounder of Practicing Physicians of America, the act gives drug makers seven-year market exclusivity (meaning no other company can advertise the same version of the drug), a 50% tax credit on the cost of conducting clinical testing, and access to grants to conduct that testing. In addition, a company studying a drug that’s been granted orphan status can apply for a voucher to speed up the FDA approval process by several months, getting the drug on the market faster—a prospect that lets companies turn a profit sooner. A company with a voucher can auction it off to other pharmaceutical companies, selling it to the highest bidder. “These [vouchers] are highly valuable and have been...worth tens or even more than $100 million,” Vinetz said. “I have a feeling that this pharma company wanted to do what Gilead did [with remdesivir] by applying for orphan drug status for camostat.” 

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