FDA Remains in the Hot Seat
The ability of the US Food and Drug Administration to effectively regulate the safety of drugs, medical devices and food, continues to be an issue of debate. This week, the US Government Accountability Office (GAO) issued a report that named FDA among the federal government’s high-risk areas. GAO issues the list at the start of each Congress to help identify legislative priorities and issues.
In January 2007, GAO detailed 27 high-risk areas in the federal government and, in March 2008, added a 28th—planning for the 2010 Census. In January 2009, it added three more: protecting public health through enhanced oversight of medical products; transforming Environmental Protection Agency’s processes for assessing and controlling toxic chemicals; and modernizing the US financial regulatory system.
In its report, GAO was explicit in questioning FDA’s ability to effectuate drug safety and addressed specific weaknesses in the agency. “Concerns have been expressed about FDA’s ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics, and medical devices,” said the report. “GAO’s work examining a variety of issues at FDA echoes the conclusions reached by others that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug-inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.”
Although not addressing the specific issues raised by the GAO report, Acting FDA Commissioner Frank Torti acknowledged the challenges facing the agency in his first public statement issued on Jan. 21.” I am using this first communication as an opportunity to introduce, in my own words, some thoughts about the FDA…,” he said. ““I will need your help. The job of Acting Commissioner is more difficult (if that is possible) than that of the Commissioner. For many issues, we await the guidance of our new administration. This is as it should be, and we embrace the opportunity to help them implement their vision for the FDA. Yet the work at FDA must be neither tentative nor delayed. Rather, we must steer the Agency with continued energy, enthusiasm, and insight. We must continue to apply scientific thought and process to our regulatory decisions – based, as always, on the laws that govern our food and drugs.”
Perhaps signaling a greater receptivity toward change, Torti said: “To members of Congress and others who oversee our Agency, we need your partnership to reshape the agency and to provide us with the resources and legislative authorities necessary to support our work.”
As a new administration and Congress assume power, the pharmaceutical industry will be watching how vigorous those efforts for reforming FDA will be.
Seemingly food safety would have also been included as a priority for additional consumer protection and who better than FDA to assume that role in addition to the added burden it will surely receive to oversee medical products. I’m afraid FDA is being spread too thin and the demands of Congress will lead to competition among its centers for field operations resources. This will only drain Agency staff to secure these resources, not to mention the time it will spend reporting to Congress and GAO. Maybe the Agency ought to take preemeptive action rather than wait to be directed by Congress. Would it consider decentralization of ORA to make sure that it can adequately dedicate resources to the different types of products it regulates before it gets to the point where it doesn’t know which way to turn?
There is a critical shortage of infroatmive articles like this.