Generic versions of erectile dysfunction drugs Viagra and Cialis, among other medications, were allowed on the U.S. market using potentially problematic data that call into question their safety and efficacy, a Bloomberg analysis found.
The U.S. Food and Drug Administration alerted brand-name and generic companies June 18 about a research company in India that had falsified the data used in key studies to gain approval of its medications.
Data from the researcher, Synapse Labs Pvt. Ltd., may have been used in hundreds of drugs, which remain available for sale on pharmacy shelves and in Americans' medicine cabinets.
European regulators last year flagged Synapse to the FDA, which later told U.S. companies that relied on Synapse for key studies to gain approval of their medications that they would have to redo the work somewhere else.
The FDA said companies that used Synapse will get a year to submit new data on the drugs. Without that information, it's difficult to know the true outcomes of the studies and whether they're safe. And insurers may have reason to retroactively decide not to cover the medications.
"I think it raises a lot of questions about the implications for the drugs on the market," said Massoud Motamed, who was an FDA inspector until January 2023 and has a doctorate in biochemistry. Motamed said his biggest concern is that the drugs Synapse was involved with may have too much or too little active ingredient. Too much can lead to dangerous toxicity issues.
Drugs.