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With Limits Of OTC Drug Fact Label ‘Simple Boxes,' Complicated Conditions Remain Rx-Only In US

 
• By Malcolm Spicer

Merck & Co.'s three lovastatin switch attempts showed "it would be essentially impossible to present what they needed just within the confines of those simple boxes,” says Pegasus Research CEO Clark Richardson. Two decades after DFL launched, FDA, labeling experts and other industry stakeholders recognize its limits and have more consumer comprehension study data to guide decisions on what to include as well how to format an OTC label.

Merck & Co.'s modifications to the DFL for its proposed OTC switch of Mevacor in 2007 didn't convince FDA to approve what would have been the first nonprescription drug indicated for a chronic condition. • Source: Pegasus Research/FDA webinar

The futility of using OTC Drug Facts labels for products indicated to treat conditions more complicated than a cold or heartburn, headaches or allergies was apparent less than 10 years after the format was launched.

That was when Merck & Co., Inc. in 2007 made its third and final unsuccessful attempt to switch a...

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More from Regulation

Opella: Unlock Volume Growth By Expanding Access And Deepening Category Penetration

 
• By David Ridley

Negative growth in global OTC market sales volume means that “as an industry, we're not doing good enough,” argues Opella’s Asia Pacific, Middle East and Africa (AMEA) head, Carol-Ann Stewart, in this exclusive feature interview.

Like Claims Of Prenatal Acetaminophen Exposure Risks, Petition For Warning Is ‘Unreliable’ – CHPA

 
• By Malcolm Spicer

Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”

Norway Decides Against Tighter Restrictions For Ibuprofen

 
• By Tom Gallen

Norway's Medical Products Agency has rejected claims that misuse of OTC ibuprofen is linked to its availability for purchase in outlets other than pharmacies.

Latest OTC Eye Drop Production Problem In US Prompts Firm To Close Doors After Recalls

 
• By Malcolm Spicer

BRS Analytical Services in St. Louis recalled more than 75,000 cases of redness and lubricating eye drops and committed “to permanently cease production of all drugs.”

More from Policy & Regulation

Stopgap Spending Bill Provides Platform To Plug Gaps In FDA’s OTC Monograph, Switch Pathways

 
• By Malcolm Spicer

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

Bayer: Product Launches Alone ‘Not Enough’ To Meet Women’s Health Needs

 
• By David Ridley

“It’s not good enough just to provide products anymore, we need to create a service and a holistic approach to products,” argued Bayer Consumer Health's Northern Europe general manager, Mike Knowland, speaking at a recent panel event in the UK Parliament.

BMJ Study: No Clear Link Between In Utero Paracetamol Exposure And Autism, ADHD

 
• By David Ridley

The studies reviewed by BMJ researchers failed to account for the fact that the association between in utero exposure to paracetamol and autism and ADHD in childhood “might be driven by familial genetic and environmental factors.”