Rescue Medicine Switch Concept Draws Criticism

FDA considers switching some prescription “antidotes” to restricted nonprescription status so consumers who can self-identify their need for the drugs and who previously had a prescription can easily access them during life-threatening events, says CDER Director Janet Woodcock.

FDA officials argue expanding nonprescription access to some rescue medicines under a potential new switch paradigm could save lives in emergencies, but health care advocates argue the move could do more harm than good by delaying necessary long-term care.

The agency is considering switching some prescription “antidotes” to restricted nonprescription status so that individuals who can self-identify their need...

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

More from Distribution/Supply Chain

Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

 
• By 

Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

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

 

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.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

More from Compliance

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.