Advance notice of mysterious rule puts drug-pricing people on edge image

Politico Prescription Pulse, October 22, 2018
Sarah Karlin-Smith, featuring Holly Fernandez Lynch (Former Executive Director)

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Holly Fernandez Lynch, a medical ethicist at the University of Pennsylvania, wonders whether FDA will audit third-party invoices to make sure manufacturers aren’t profiting from these sales. She sees pros and cons in the WideTrail approach. Pros include opening up investigational drugs to more patients. She also said the approach is “infinitely better” than the new right-to-try pathway because WideTrial will be collecting research data and reporting it to FDA. Con: These are still investigational drugs and we don't know whether they’ll work. “So patients are being charged for a lotto ticket. And relatedly, they are buying that ticket with their own funds because their insurers are not going to pay for something we don't know works,” Fernandez Lynch said. WideTrial told BioCentury that it won’t make money by charging patients for the experimental drugs. Profits would instead come from selling its aggregated data to the drug developer.

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