Congress Passes FDA Bill With Provisions to Deter Drug Counterfeiters, Ban Synthetic Drugs, Help Prevent Drug Shortages

July 5, 2012 3:01 pm Topics: Counterfeit drugs and Federal regulations

The Food and Drug Administration (FDA) Safety and Innovation Act (S 3187) was passed by United States Congress, June 26, 2012, and would implement provisions addressing counterfeit drugs, synthetic drugs, and drug shortages. The bill would increase penalties for drug counterfeiting, changing the maximum penalty to $4 million and up to 20 years in prison. The current maximums are $10,000 or three years in prison. To help prevent drug shortages, the legislation requires drug manufacturers to notify FDA at least six months before discontinuing production of a drug. New provisions regarding both domestic and foreign inspections would also help to ensure drug quality and safety. In addition, the bill would ban 28 chemicals used in synthetic “bath salt” drugs. President Obama is expected to sign the bill into law. More information is available in a Washington Post article.