Schulman: FDA Should Back Independent Generic Drug
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- Generic drugs account for roughly 90% of prescriptions dispensed to Americans, driven by their lower cost.
- The FDA attributes over 60% of generic drug shortages to quality concerns, with India-based manufacturers frequently cited for manufacturing protocol violations that triggered recalls and U.S. import bans.
- Kevin Schulman, professor and deputy director of Stanford's Clinical Excellence Research Center, argues the FDA should encourage testing by independent, accredited laboratories.
- Valisure, an independent lab that has worked with Schulman, has documented impurities in some widely used medicines, supplying real-world evidence for the independent-testing proposal.
- U.S. regulators have responded to quality failures with repeated citations and import restrictions on foreign generic producers, illustrating the limits of the current inspection-based oversight model.
Why it matters: Consumers fill 90% of prescriptions with generics, yet the FDA ties 60%+ of shortages to quality problems and has repeatedly restricted India-made products; if Schulman's independent-lab approach gains traction, accredited third parties could screen medicines before they reach patients, adding a verification layer that the current FDA inspection regime has failed to provide on its own.
