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# Patient Advocate Urges Safety Metrics in PDUFA, GDUFA Deals
- URL: https://www.fdaweb.com/patient-advocate-urges-safety-metrics-in-pdufa-gdufa-deals/
- Published: 2026-10-01T23:18:44.000Z
- Updated: 2026-10-01T23:18:44.000Z
- Author: David McFarland
- Tags: Drugs

Patient-safety advocate **Suzanne B. Robotti** is calling for stronger postmarket safety and drug-quality accountability measures to be added to the upcoming reauthorization of the brand and generic drug user fee programs. Writing in an 10/1 MedShadow [opinion piece](https://medshadow.org/drug-updates-recalls/drug-safety/pdufa-gdufa-patient-safety/?ref=fdaweb.com), Robotti said she urged FDA during September public meetings on PDUFA and GDUFA reauthorizations to mandate safety and quality metrics into the agreements, arguing that industry obligations should receive greater attention after products reach the market.

Robotti, founder and president of MedShadow, said FDA faces specific performance deadlines for application reviews and interactions with drug companies, while manufacturers may face less accountability when postmarket safety reports or required follow-up studies are delayed.

She also highlighted manufacturing concerns involving generic drugs, including potency, dissolution and contamination problems, and argued that FDA and manufacturers need to respond more rapidly to emerging safety signals.

“Speed cannot be the only measure of success,” Robotti wrote, arguing that the next PDUFA and GDUFA agreements should strengthen protections after drugs reach the market as well as mechanisms intended to expedite their review.