Eva Temkin, Life Sciences & Healthcare Regulatory partner and former Acting Policy Staff Director at the FDA's Office of Therapeutic Biologics and Biosimilars, was recently featured in two BioSpace articles, "IRA Leaves Orphan Drugs Stranded Even as Regulators Promise Progress" and "Trump's Tax Law Restores Orphan Drug Exemptions, Cuts Medicaid, Threatens 340B Program and Gives PBMs a Pass." Both pieces explored the evolving regulatory and policy landscape for orphan drugs under the Inflation Reduction Act (IRA) prior to President Trump's newly enacted tax legislation.
Temkin expressed concern that the IRA's narrow exemption for orphan drugs failed to support continued innovation adequately. "I do think that the way that the orphan exception to the IRA is structured is insufficient to continue incentivizing orphan drug development in the face of the costs and various externalities imposed by the IRA," she said. "And it does sort of go against decades of Congress trying to catalyze orphan drug development and things like the Orphan Drug Act."
She also highlighted that the prior IRA's framework especially disadvantaged platform technologies targeting multiple rare diseases.
Read the BioSpace article: IRA Leaves Orphan Drugs Stranded Even as Regulators Promise Progress
Read the BioSpace article: Trump's Tax Law Restores Orphan Drug Exemptions, Cuts Medicaid, Threatens 340B Program and Gives PBMs a Pass