Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings

Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn’t meet FDA’s safety standards. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA currently has a major operation underway to investigate and address this troubling finding. This investigation is led by a dedicated task force of experts focused solely on this important work. Their mandate is to oversee the investigation and track new developments and information coming in from valsartan manufacturers. This multidisciplinary team of chemists, toxicologists, medical doctors, pharmacists, investigators, communication specialists, and analytical lab staff coordinates across the FDA, and acts on the newest available information. Continue reading...

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

		The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Continue reading...

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

Over the past 17 months, we’ve set out to address the opioid crisis forcefully, using all the agency’s tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas. Continue reading...