FDA at a Crossroads - Pharmaceutical Technology

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FDA at a Crossroads
Will more resources and new leadership fix FDA, or is a major overhaul in order?

Pharmaceutical Technology
Volume 33, Issue 1, pp. 32-40

Moving food regulation out of FDA, though, would be highly disruptive, and agency officials are taking steps to demonstrate their ability to prevent and resolve food-contamination problems. A one-year progress report issued in December 2008 details the many initiatives underway for implementing the 2007 Food Protection Plan. FDA is improving analytical methods, conducting more field inspections, establishing new oversight methods, and adopting better approaches for responding to contamination outbreaks.

Agency leaders also propose a less radical change that involves splitting FDA into two directorates—one for food and one for medical products—each headed by an experienced administrator. Food companies, who feel they play second fiddle to drug manufacturers at FDA, support such a move. So do medical-product companies that fear the effects of more restrictive food-import policies.

The political reality is that a major change such as taking the food oversight responsibilities from FDA is not likely to happen anytime soon. The new Obama administration has more crucial tasks at hand in the economic and health arenas, and most members of Congress are unenthusiastic about altering committee oversight responsibilities.

Former FDA official Wayne Pines is skeptical that reorganization will improve agency operations, noting that such efforts usually end up "just moving boxes around and not increasing efficiency." But if Congress follows through on proposals to authorize FDA to regulate tobacco, the modification could provide an opportunity for additional changes in agency structure and operations.

Strong leadership

Improvements in FDA's operations, resources, and infrastructure will be shaped considerably by the next FDA commissioner. Lots of names have been circulating since the election, and the discussion is a sign of the agency's high visibility and importance to the new administration and to Congress. Industry wants to get a new commissioner on board as soon as possible to confront the many management challenges the agency faces, says Alan Goldhammer, vice-president for regulatory affairs of the Pharmaceutical Research and Manufacturers of America (PhRMA). The industry hopes that FDA's new leader will be named and confirmed by the Senate in a few months, instead of languishing at the bottom of the White House appointments list.

One priority for the new commissioner will be to justify continued growth in appropriated funds for the agency's 2010 budget. The Alliance for a Stronger FDA has called for a 20% increase in FDA appropriations to $2.25 billion for next year. That amount contains less than $400 million in new money, a drop in the bucket for most federal agencies.

FDA and industry also hope that Democratic control of the White House and Congress will result in fewer heated attacks on the agency from Capitol Hill. Lawmakers may be less inclined to use FDA as a punching bag, but the agency always will be controversial because of the nature of its operations and the scope of products it regulates, says Pines.

The bottom line for pharmaceutical manufacturers is whether FDA can approve new drugs for market and oversee product development, manufacturing, and marketing in a fair and efficient manner. All the attention on drug safety has raised concerns about a more risk-averse atmosphere at the agency and slowdown in product authorizations. Manufacturers say they're willing to see whether things improve in the coming months before getting too upset about CDER missing user-fee deadlines. "The agency was given a significant number of new authorities and tasks to accomplish and has been hiring and training a lot of new employees," explains Goldhammer. "So it really is this upcoming year that will be critical in looking at performance and benchmarking against [Prescription Drug User Fee Act] goals."

A bright light on the horizon is an increase in the number of innovative new drugs approved by FDA in 2008. The agency experienced a new low in approvals of new molecular entities (NMEs) in 2007, and it looked like 2008 would be just as bad or worse. FDA reviewers were missing review deadlines, demanding additional data, and imposing stiff postmarket monitoring requirements on products that made it through the process. But in November 2008, FDA surpassed the 2007 total of 18 NME approvals and appeared on track to act on several more before year's end. Although it's always easier to show gains from a low starting point, industry and FDA are happy to consider this increase as a sign of hope for the new year.


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