1. HBW Insight
  2. >>Archive

Will ACNU Proposal’s Dual Rx/OTC Component Simultaneously Help And Hinder Switches?

 
• By Malcolm Spicer

Proposal is counter to fundamental of FDA platform for approving drugs as either Rx or OTC, with a formulation of a drug with a certain indication available in one class, not both. CHPA says the proposal also runs counter to encouraging pharma firms to invest in research needed for OTC switches.

• Source: Shutterstock

Allowing simultaneous Rx and OTC sales of the same drug, a part of a US proposed rule for facilitating OTC switches, could help pharma firms “have the best of both worlds” but also could become a disincentive for investing in preparing applications to move ingredients to nonprescription.

In a separate reference in its recent notice on preparing applications for OTC distribution of naloxone, the Food and Drug Administration suggested the opposite, saying it wouldn’t allow simultaneous Rx and

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight 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 Archive

FTC Consumer Privacy Policy Driven By ‘Straw Man’ Arguments – Commissioner Holyoak

 
• By Eileen Francis

The US FTC’s contention that ‘notice and choice’ has failed as the cornerstone of consumer privacy regulation and must be abandoned in favor of data minimization and other more stringent measures does not adequately account for the complexity of business practices and consumer behavior, FTC commissioner Melissa Holyoak asserted at the NAD’s 2024 Annual Conference.

FTC’s New Commissioner ‘Dismayed’ By Agency Overreach

 
• By Eileen Francis

FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements. 

Beauty Brands Not On TikTok Shop ‘Really Missing Out’ – KO-Pack

 
• By Eileen Francis

At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

More from HBW Insight

IFF Offsets Tariffs’ Impact, But Discretionary Product Ingredients Face Risk

 
• By Eileen Francis

New York-based International Flavors & Fragrance, Inc. has shifted procurement to alternative supply sources and is balancing production across its global network in response to US tariffs, though company executives say ingredients for discretionary products face risk.

Global Alliance Urges UN General Assembly To Put Self-Care At Centre Of NCD Strategy

 
• By David Ridley

Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.

Danes Get OTC Access To ED Treatment

 
• By Tom Gallen

Navamedic has launched Eroxon in Danish pharmacies giving men in the country OTC access to an ED treatment for the first time.