1. Pink Sheet
  2. >>Legislation

Opioid Policy At US FDA: Over-Promising Or Overreacting?

 
• By Michael Cipriano

As President Trump signs SUPPORT Act, former FDA chief counsels offer dueling interpretations of agency's impact in combating opioid crisis.

Skull-shaped pills in Halloween colors
• Source: Cindy Shebley

President Trump signed into law Oct. 24 the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act that gives the US FDA new authorities to tackle the opioid crisis, exemplifying a potential conundrum of whether the agency is over-promising or overreacting on the epidemic.

Richard Cooper, who served as FDA chief counsel from 1977 to 1979, questioned whether FDA Commissioner Scott Gottlieb has set...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legislation

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

More from Pink Sheet

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 
• By Neena Brizmohun

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.