Empowering the FDA to Stop Counterfeit Drugs
After years of neglect, I’m glad to see Congress give drug safety the attention it deserves. Last week, Reps. John D. Dingell (D-MI 15), Frank Pallone, Jr. (D-NJ 06) and Bart Stupak (D-MI 01) introduced the Food and Drug Administration Globalization Act of 2009 (H.R.759). In addition to addressing several food safety issues, the proposed legislation addresses the real threat of substandard and counterfeit drugs.
In fact, this bill incorporates a number of the Partnership for Safe Medicines’ Principles for Drug Safety, including
- Strict, rigorous regulatory oversight of imported pharmaceuticals
- A dramatic and sustained increase in funding for the FDA
- Increased inspections of foreign facilities that manufacture drug products or components of drug products sold in the United States
- Stronger criminal and civil penalties against the perpetrators of counterfeit drugs
- Granting the FDA authority to destroy unapproved drugs entering the United States rather than returning them to the criminals who sent them here
In the coming weeks, we’ll take a closer look at the drug and medical device safety components of the FDA Globalization Act of 2009. It is our hope the proposed changes will address the counterfeit drug and online pharmacy issues threatening the safety of our drug distribution system.