KFF HEALTH NEWS – A flurry of lawsuits were filed last week after an FDA panel concluded the ingredient phenylephrine was essentially ineffective. Meanwhile, the FDA says it will seek public opinion before deciding whether to remove the ingredient from store shelves.
Reuters: J&J, P&G, Walgreens Sued After FDA Panel Ruling On Cold Medicine Decongestant
Johnson & Johnson, Procter & Gamble and Walgreens are among several companies accused in lawsuits of deceiving consumers about cold medicines containing an ingredient that a unanimous U.S. Food and Drug Administration advisory panel declared ineffective. Proposed class actions were filed on Wednesday and Thursday, after the panel reviewed several studies and concluded this week that the ingredient phenylephrine marketed as a decongestant was essentially no better than a placebo. (Stempel, 9/14)
Reuters: US FDA To Seek Public Opinion Before Banning Popular Cough Syrup Ingredient
The U.S. Food and Drug Administration said on Thursday it would seek public opinion before finalizing its decision to remove a decongestant widely used in cough syrups from the agency’s list of ingredients for over-the-counter (OTC) use. The FDA’s clarification follows a unanimous vote by its panel of outside experts on Tuesday against the effectiveness of oral OTC medicines made with phenylephrine, an ingredient widely used in cold and cough syrups. (9/14)
On the FDA’s struggle with drug shortages —
Roll Call: Partisan Divide On Drug Shortages Unresolved After Hearing
Democrats and Republicans on the House Energy and Commerce Committee appear no closer to resolving differences around prescription drug shortages after a legislative hearing in the Health Subcommittee on Thursday. The debate is entangled in a stalled reauthorization of a pandemic and emergency preparedness law that expires Sept. 30. (Clason, 9/14)
Stat: House Panel Takes First Step Toward Fixing Drug Shortages
A House subcommittee took a first step Thursday toward legislation to fix drug shortages at hospitals. Don’t expect a new law soon, though. Asked if he expects the House to pass a bill on the subject this year, Energy and Commerce health subcommittee Chair Brett Guthrie (R-Ky.) said drug shortages are an emergency, “but the proposals that have been offered aren’t going to fix it by tomorrow or the next day.” (Wilkerson, 9/14)
Roll Call: After Infant Formula Crisis, Lawmakers Look To Donor Milk
An infant formula shortage last year that left store shelves empty and parents panicked spurred lawmakers to scramble for solutions. One year later, some think they’ve found one: Donor breast milk. On Thursday, a bipartisan group of lawmakers led by Sen. Tammy Duckworth, D-Ill., will introduce a bill that aims to increase access to pasteurized donor milk for infants and push the FDA to regulate the practice. (Cohen, 9/14)
On drug patents —
Stat: FTC Warns Drugmakers Over Improper Patent Filings
The Federal Trade Commission warned pharmaceutical companies they could face legal action if they improperly list patents for brand-name medicines in a Food and Drug Administration registry, the latest effort by the federal government to scrutinize patent moves by drugmakers. (Silverman, 9/14)
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