A pair of lawmakers wants the US Food and Drug Administration to explain its rationale for approving a decades-old drug to treat a rare disease that has caused controversy after the manufacturer, Marathon Pharmaceuticals, set a surprisingly high price of $89,000 a year.
In particular, the lawmakers are upset that the agency extended two coveted prizes — orphan drug designation and a priority review voucher —that provide Marathon with seven years of marketing exclusivity and, potentially, extra cash even though the company did not invent the drug.
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While I respect the Senator’s right to quote ‘more effective, safe and more affordable,’ I have heard FDA say that the price/ economic factors around a drug are not within their purview to review. As I know the FD&C Act, the criteria are ‘Pure, Safe and Effective.’ The economic$ are not included.