In Brief: CHPA Disagrees With FDA Warning; Adulterated Supplements Enforcement; DASCA Support Sought

FDA warns about painkillers for teething; enforcement against adulterated supplements; FDA warning letter for tainted bee pollen; Akorn must divest brands from Hi-Tech deal; senators seek support for DASCA; and consumer acetaminophen knowledge improves.

The Consumer Healthcare Products Association disagrees with a consumer update that FDA issued June 26 that suggests topical pain relievers and medications that are rubbed on the gums to relieve teething pain are not necessary or useful because they wash out of children’s mouths within minutes. The announcement does a “disservice to parents and caregivers who use FDA-approved OTC gel and liquid medicines containing benzocaine to treat their children’s suffering from teething pain,” the trade group said. The consumer alert directs caregivers not to use local anesthetics such as Rx viscous lidocaine or OTC benzocaine-containing products except under the advice and supervision of a health care provider.

The agency said in the alert that it ordered a black box warning added to Rx oral viscous lidocaine 2% solution because the ingredient can cause seizures, brain injury and heart problems, according to the alert. The decision followed a review of 22 serious adverse event reports in young children who accidently ingested the Rx drug after it was administered for mouth pain

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 United States

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By 

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By 

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

More from North America

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
• By 

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.