Is there a real move afoot to give FDA new powers? Could be. Several weeks ago, in the midst of the hearings over Johnson & Johnson's (NYSE: JNJ) consumer-drug recalls, Rep. Edolphus Towns (D-NY) introduced a measure that would give the FDA the right to declare a recall on its own, rather than cajoling drugmakers to do so. And now, a senator has authored an even-more-intensive FDA-empowerment bill.
Sen. Michael Bennet (D-CO) not only advocates recall powers for FDA, but wants the agency to have more resources and power to oversee foreign drug manufacturing. The bill would raise the bar on manufacturing standards. It would give the FDA better tools for monitoring and tracking global manufacturers that supply everything from raw materials to finished products. And it would give the agency more enforcement powers, such as the ability to levy civil penalties and subpoena records.
Drugmakers would bear a bigger regulatory burden, too; companies would have to document their supply chains from beginning to end, for instance. And that prospect isn't thrilling to PhRMA. "Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America's prescription drug supply," PhRMA's Ken Johnson says in a statement. So, expect plenty of debate if Bennet's bill goes anywhere.
- see PhRMA's statement
- read the story at The Hill
- get more from PharmTech Talk
- see the in-Pharma Technologist piece