Two FDAs Rejected By Rep. Waxman, Says Fixing Food Safety Is First Priority

The idea to divide FDA into two separate agencies - one that regulates drugs and devices and another that regulates foods - was dismissed by House Energy and Commerce Chairman Henry Waxman as the wrong priority for Congress and the agency.

Instead, the "first step on the legislative path" should be shoring up food safety and finding ways to prevent further incidents, Waxman said at a Health Subcommittee hearing March 11.

Waxman acknowledged that "a lot of good points have been made" by his congressional colleagues and other stakeholder about the need to improve FDA's "fragmented" regulatory system and "ensure that food safety is given appropriate attention by our regulatory agencies."

But given the recent challenges FDA has faced in protecting the public from unsafe foods, he doesn't think a restructuring is the best use of resources. "Reorganizing federal bureaucracies takes a great deal of time - and this is time we do not have when it comes to food safety."

William Hubbard, a former associate commissioner at FDA, agreed with Waxman, testifying at the hearing that Congress should first address current problems before looking at a separate agency.

For the biopharma industry, an FDA focused on drug and device regulation would be more accountable for the regulation of medical products - something that could be seen as a mixed blessing (See "¹ Food for Thought: The Case for Two FDAs," The RPM Report, November 2007).

Waxman did suggest that he would entertain the concept of a bifurcated agency in the future. Once reforms are passed and implemented, he suggested Congress could consider "whether a reorganization is necessary" for food safety enforcement.

Waxman Versus DeLauro

Food safety is not a new topic - in the past few years, FDA has implemented recalls of tainted spinach, tomatoes and bottled water. But the need for reform climbed Congress's priority list after nine deaths and a flurry of product recalls related to salmonella-tainted peanut products.

The most outspoken supporter for splitting FDA into separate agencies is Rep. Rosa DeLauro, D-Conn. Like Waxman, DeLauro is a powerful voice in Congress. She chairs the House Agricultural Appropriations Subcommittee, which oversees FDA's budget.

DeLauro reintroduced the Food Safety Modernization Act this session, which would move some divisions out of FDA and form a Department of Health and Human Services agency for food safety. The bill, H.R. 875, has 40 cosponsors.

Rep. Anna Eshoo, D-Calif., expressed support for DeLauro's bill during the hearing, saying that more funding is necessary. "We are doing [food safety enforcement] on the cheap ... and as long as we do that, we'll be plagued" with contamination problems.

Hamburg Brings Food Experience To FDA

DeLauro has argued that under the current structure, food regulation is spread out among several different agencies - including FDA - and that consolidating oversight is sorely needed to prevent and respond to food safety outbreaks.

Too often, DeLauro has said, food safety priorities are relegated to a "second-tier status," without the proper attention from FDA leadership: "Presidents choose FDA commissioners to address drugs," not foods, she said at 2007 conference.

That precedent is likely to change, based on the Obama administration's expected nominee for FDA commissioner, Margaret Hamburg (² (Also see "FDA Commissioner Hamburg: White House Close To Formal Announcement" - Pink Sheet, 9 Mar, 2009.), p. 9).

As a former New York health commissioner, Hamburg has the most food safety experience of any FDA commissioner in recent years.

The Obama administration had been understood to be considering splitting FDA oversight between Hamburg and her expected principal deputy, Joshua Sharfstein, to reflect their different resumes - and the desires of top FDA powerbrokers in Congress. It's unclear, though, whether the two roles will be explicitly broken out.

- Katie Stevenson ([email protected])