Industry user fees are one of the few ways to raise revenue it seems we haven’t heard much about over the past few weeks, as Congress has become engulfed in the debt ceiling debate. But they’re nevertheless a critical piece in funding the FDA’s system to review and approve new drugs, and may also be a key in helping the agency to meet the rapidly increasing challenges of protecting U.S. consumers from safety gaps in overseas manufacturing of drugs and medical devices.
That’s the focus of a Senate HELP committee hearing tomorrow, and the FDA Commissioner Dr. Margaret Hamburg will be there to testify. Hamburg has put these challenges out front in a recent report and public remarks (including at Public Citizen on Monday), and tomorrow’s hearing offers her an important opportunity to discuss what it will take—in resources, authorities and partnerships—for the agency to get from here to there. One industry group, the generic drug trade organization, has already publicly come out in favor of user fees to support better FDA oversight of suppliers.
Here are some questions we think the Senators should consider asking Hamburg:
Pew’s After Heparin report and the FDA’s “Global Pathway” report both pointed again to the fact that companies that make drugs in the U.S. are inspected every 2-3 years, while those that manufacture in foreign facilities only get inspected once every 9 years.
- Shouldn’t we be ensuring that foreign drug manufacturers which operate in many countries with loose regulation have to meet the same standards as U.S. companies?
- Is weak regulation helping to foster outsourcing of U.S. drug manufacturing?
- If manufacturers continue to outsource, is increasing the level of foreign inspections one way to level that playing field? How else?’
- Does the law governing the FDA’s mandates and authorities—the Food Drug and Cosmetic Act—match the current challenges created by the complexity of our global drug supply?
- Does the law allow the FDA to adequately monitor and keep safe such an outsourced industry? If not, what kind of consensus is there around what to do?
- Do you believe we need such a tracing system, and what is FDA’s role in developing one?
- Does the FDA need additional authorities or a statutory mandate to ensure drug traceability becomes a reality?
–Kate Petersen, PostScript blogger