GOP tax reform bill would repeal orphan drug research credits
Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern.
Under the House bill’s Subtitle E, section 3401 would repeal what amounts to half of the qualified clinical research costs for designated orphan drug products.
Background
Under the Orphan Drug Act of 1983, Congress sought to incentivize the development of drugs to treat rare diseases by offering drugmakers tax credits, fee waivers and a seven-year period of marketing exclusivity for an approved orphan indication. To qualify for the designation, a product must be intended to treat a disease that affects fewer than 200,000 people in the US, or more than 200,000 if the drugmaker can show that it is not expected to recoup its costs to develop and market the drug.
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