The FDA Commissioner says the realignment of four deputy-level offices in the Office of the Commissioner will streamline "common activities" and strengthen science and food safety.

The agency has reorganized the deputy-level offices with oversight of science, administration and policy and elevated the Office of Foods to the same tier, reporting directly to the commissioner's office, according to an Aug. 18 Federal Register ¹ notice.

Meanwhile, FDA is conducting a nationwide search for its first deputy commissioner for food to head that office. This position has oversight of all the agency's food activities including the Center for Food Safety and Applied Nutrition and food-related functions of the Office of Regulatory Affairs and the veterinary center.

The notice makes official the ² reorganization plans Commissioner Margaret Hamburg identified in a June 29 memo to Health and Human Services Secretary Kathleen Sebelius (³ Also see "FDA Creates Food Czar In Agency-Wide Reorganization" - Pink Sheet, 13 July, 2009.).

FDA's notice also details the duties of the newly established Center for Tobacco Products, mandated by the Family Smoking Prevention and Tobacco Control Act (⁴ Also see "Tight 90-Day Countdown To Create Tobacco Center Poses Challenge To FDA" - Pink Sheet, 15 June, 2009.). The agency named Lawrence Deyton director of its tobacco center Aug. 19 (see ⁵ Also see "FDA Choice For Tobacco Chief Suggests Bigger Role For Cessation Programs" - Pink Sheet, 24 August, 2009.). Like most of the centers, CTP reports to the commissioner's office.

At an FDA Science Board meeting Aug. 17 in Rockville, Md., Hamburg said the changes within her office are not "enormous" but are being made "to try to align critical areas of activity in ways that bring common activities together with greater responsibility, oversight and opportunities for synergy."

Mark Mansour, an attorney with Washington-based Bryan Cave, said the reorganization reflects moves Hamburg indicated she would prioritize. "The objective seems to be to give the commissioner the ability to better oversee the scientific functions and food, both articulated as major issues by Commissioner Hamburg," he said.

"Generally, I expect more personnel changes and more direct oversight of the various centers and offices by the commissioner's office," he added.

Strengthening Science, Food Safety

The new structure "will allow the agency to better focus the science and research activities" of the chief scientist's office, the notice says.

In Hamburg's earlier memo, which sketched in more detail, the commissioner said she would expect acting Chief Scientist Jesse Goodman and his staff to promote innovation, bolster recruitment of young scientists, make better use of the agency's toxicology research center and improve information technology support for the agency's scientific programs.

Under the new setup, the Office of the Chief Scientist maintains oversight of critical path programs and picks up the Office of Counter-Terrorism and Emerging Threats from the former Office of Policy, Planning and Preparedness, which is renamed the Office of the Policy, Planning and Budget in the reorganization.

Several areas shift out of the science office to the new Office of the Special Medical Programs, which also reports directly to the commissioner. These include the offices of Pediatric Therapeutics, Combination Products, Bioresearch and Monitoring, and Orphan Products Development.

Further, the science office takes on two brand new offices - Scientific Integrity and Science and Innovation.

Ivan Wasserman, a food and drug attorney with Washington-based Manatt, Phelps & Phillips, said the changes "reflect a focus of the agency under the new administration on two areas for which it has been criticized in the recent past: science and food safety."

Wasserman said the realignment of the chief scientist's area gives "greater oversight responsibility" to the post.

He noted the scientific integrity office is responsible for handling issues similar to the agency's consideration of the Plan B emergency contraceptive switch, "where there was apparently scientific disagreement among various officials."

In an April letter to President Obama, nine agency scientists accused FDA executives of caving to political pressure in their handling of Barr Labs' application to switch Plan B to over-the-counter status (⁶ Also see "FDA Scientists Say Plan B Decision-Makers At CDER “Should Be Removed”" - Pink Sheet, 6 April, 2009.).

The scientists' complaint followed a federal court ruling saying FDA's decision to set an age limit and pharmacy-only marketing conditions for Plan B was "arbitrary and capricious." The ruling required FDA to reconsider whether to make Plan B available to all women without a prescription and allow nonprescription sales to 17-year-olds (⁷ Also see "Plan B Ruling: Little Commercial Impact, Big Policy Implications" - Pink Sheet, 30 March, 2009.).

In the reorganization notice, FDA said the Office of Scientific Integrity's responsibilities include ensuring "consistent understanding, application and implementation of regulatory standards throughout FDA to ensure integrity and accountability of FDA functions and processes."

Further, the office "investigates and resolves informal complaints and disagreements, whether generated internally or externally, with respect to administrative processing of various applications for products regulated by the agency as well as regarding the fair and even-handed application of agency policy and procedures in this process."

The notice says the Office of Science and Innovation is charged with "supporting excellence and the professional development of FDA scientists in all areas" and "fostering development and use of innovative technologies to meet public health needs, including their evaluation, quality, safety and effectiveness."

Priority For Foods

Wasserman noted the Office of Foods will directly report to the commissioner under the reorganization, whereas before it was part of the Office of Operations, which is renamed the Office of Administration.

Hamburg pointed out in the June memo that the food czar post would be directly responsible to her office. "There is no higher priority than assuring the public that we intend to make the food safety program at FDA successful," she said.

The notice says the office "directs FDA efforts to build an integrated national food safety system in collaboration with other federal agencies and state and local governments," as well as "a program of public outreach and communications on food safety, nutrition, and other food-related issues to advance FDA's public health and consumer protection goals."

Attorney Ricardo Carvajal, with Washington-based Hyman, Phelps & McNamara, said the reorganization may not be the end of Hamburg's changes.

Carvajal noted FDA established the food czar post after experts, including Mike Taylor, who has been named a senior advisor on food safety to the commissioner, asserted the agency needed a single official overseeing all food activities rather than having the responsibility dispersed across multiple centers and offices.

"Now we are going to have that person," Carvajal said. "If it doesn't work, it certainly will provide more ammunition for folks that have been suggesting that foods need to be broken out into a separate agency."

Carvajal is not a proponent of a separate food agency, but he said if the reorganization is ineffective for improving food safety enforcement, it is "not clear to me what else would work."

Budget, Planning And Communications

Hamburg also said the reorganization better links FDA's budget and planning functions within the aptly renamed Office of Policy, Planning and Budget.

"We felt that some of the budget development happened in a way that's too disconnected from the programs, and really trying to bring the budget development process into our planning process so that they go hand in hand and support each other," she said at the Science Board meeting.

The reorganization will "make sure that we're getting resources to support our goals and objectives and our program policy plans, and also put in place new performance measures to track how we're using our resources, how we're making progress towards our goal."

She added the agency is streamlining its communications staff, which was previously divided among three segments of the commissioner's office. Communications will be under an associate commissioner for external affairs.

"I think this will be key because a critical part of what we must accomplish in the years to come is more effective communication about FDA, what we do, how we do it, the decisions we made, why we made those decisions," Hamburg said.

- Katie Stevenson ( ⁸ k.stevenson@elsevier.com ); Dan Schiff ( ⁹ d.schiff@elsevier.com ) contributed to this story.

FDA Reorganization Elevates Scientific And Food Safety Priorities

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