Bryan A. Liang, MD, PhD, JDLiang (sm)
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). This legislation is beginning for Congress' efforts to address several real threats that substandard and counterfeit drugs pose to the pharmaceutical supply chain.
The bill inlcudes a number of the Partnership for Safe Medicines' Principles for Drug Safety and also introduces a Quality Risk Management Plan, which outlines specifications for safeguarding drug and medical devices, including:
* An assessment of companies contracting with a person to supply raw materials or ingredients;
* Monitoring and review through periodic on-site audits of the production facility's conditions its controls and practices;
* Monitoring incoming materials; and
* Implementation of systems to ensure the appropriate specifications, test methods and verification of the drug ingredients' identity, quality, strength, and purity.
The proposal also asks for authority to implement stronger enforcement tools, including:
* Destruction of counterfeit imports if they pose a risk of injury or death;
* Monetary and criminal penalties against offenders;
* Mandating the FDA to recall and detain unsafe drugs; and
* Allowing the FDA to subpoena records related to possible violations.
These types of proposals are fantastic first steps towards a safer drug supply. It is our hope that these proposed changes will help address the counterfeit drug and online pharmacy issues threatening the safety of our drug distribution system. They may also signal a beginning of a systematic vigilance to ensure continuous assessment and safety of the drug supply. For more information on the threat of substandard and counterfeit drugs, visit www.safemedicines.org.
