News Briefs: FDA Reveals Safety Concerns for Generics — but Doesn’t Pull Drugs
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Jul 11, 2024
Safety and efficacy data of generic versions of several drugs, including Pfizer Inc.’s Viagra (sildenafil) and Eli Lilly & Co.’s Cialis (tadalafil), may have been falsified, according to Bloomberg. Bloomberg on July 9 reported that the FDA in June notified drug manufacturers that data from Synapse Labs Pvt. Ltd., an Indian drug researcher, may have been used in hundreds of drugs currently on sale. The FDA was tipped off by European regulators about the problematic data. In an interview with Bloomberg, former FDA inspector Massoud Motamed expressed concerns that the affected drugs may have too much or too little of their active ingredient. However, the FDA has not revealed specifics about which drugmakers used Synapse’s data, citing confidentiality reasons, and has not suspended sales of any drugs — unlike EU regulators, who recommended that member states stop sales of certain drugs. Cherie Duvall-Jones, a spokesperson for the agency, told Bloomberg that "the FDA remains vigilant and will act should we identify safety issues." Read more
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