Americans at Risk of Taking Potentially Unsafe Drug from Facility Under FDA Import Ban
WASHINGTON — Americans for Safe Drugs today released a statement after Glenmark Pharmaceuticals, an Indian multinational pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) is allowing it to export product to the U.S. market from its Baddi facility, which is currently under an import ban after the FDA found significant violations of current good manufacturing practices (CGMP).
In June 2022, FDA inspected Glenmark’s Baddi facility and consequently issued a Warning Letter after finding significant violations of FDA regulations, including that its methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, and that its drug products are adulterated. As a result, the FDA placed Glenmark under an import ban and Official Action Indicated (OAI), meaning objectionable conditions were found and regulatory action should be recommended.
Despite being under an import ban, FDA provided an exception to Glenmark last month, enabling it to supply Atovaquone oral suspension to the U.S. market from its Baddi facility. In a regulatory filing, Glenmark said FDA was giving it an exception “due to medical necessity and potential drug shortage expectations.” Atovaquone is used to prevent or treat a serious lung infection called Pneumocystis pneumonia (PCP). This medication helps to stop infection symptoms such as fever, cough, tiredness, and shortness of breath.
“This decision by the FDA may put Americans at risk,” said Rosemary Gibson, author of China Rx. “Congress and the federal government have failed to support domestic production of essential generic drugs to address drug shortages. Instead, FDA is tasked with mitigating drug shortages, so it allows potentially unsafe drugs to be given to Americans from facilities that are currently violating FDA safety regulations and current good manufacturing practices. The FDA should immediately take steps to ensure that every hospital and pharmacy in the U.S. is required to notify when Glenmark’s products from this facility are being prescribed and given to patients.”
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.