Trump's Opioid Commission Asks FDA To Boost Post-Market Vigilance

Pharma is criticized for aggressive marketing, but the report also seeks industry help in research on innovative medication.

People running from dangerous pills

The final report of the President's Commission on Combating Drug Addiction and the Opioid Crisis had one recommendation specifically directed to the US FDA, calling for it to establish guidelines for post-market surveillance related to diversion, addiction and other adverse consequences of controlled substances.

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US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 

All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
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Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.