Congressional questioning during the confirmation hearing of FDA Commissioner-designate Margaret Hamburg May 7 underscored the influence the probable agency chief would have in an era of health care reform.

Several members of the Senate Health, Education, Labor and Pensions Committee emphasized to Hamburg the important role the FDA head will play as the health care reform debate unfolds into legislation and new policy.

"As you know we're working on health reform as we speak ... and we are far from getting that done in a way that will be more desirable," said Sen. Orrin Hatch, R-Utah. "But you can do more at FDA than we can do in Congress."

The HELP committee members were enthusiastic about Hamburg's pending confirmation - which might come as early as next week - noting the value of her leadership as past head of New York City's health department and on issues like tuberculosis medicine shortages. If confirmed, she will join fellow public health veteran Deputy Commissioner Joshua Sharfstein, now in his third week on the job ¹ Also see "Flu Headlines Challenge New FDA Heads" - Pink Sheet, 4 May, 2009., p. 5).

Hamburg was introduced by Sen. Dick Lugar, R-Ind. (see sidebar: " ² An Unexpected Introduction ").

For her part, she acknowledged the members' concerns, expressing her desire to create an open and transparent FDA where science trumps politics.

Many of the senators' questions focused on food safety, showing food will be earning its first-letter designation in FDA's name in the coming years; Hamburg said it would be an immediate priority.

Bringing Efficacy Into Focus

With safety also the name of the game for drugs, Sen. Barbara Mikulski, D-Md., questioned how Hamburg would guide Congress in terms of how to legislate the efficacy side of the equation, noting that researchers at Dartmouth Medical School have developed a drug fact box that may help make a clearer presentation of a product's efficacy.

Though Hamburg was not familiar with the drug fact box, she said she was interested in learning more about it. Similar in design to the nutrition label on food packaging, the drug fact box puts benefit and risk information in a numeric, tabular format (³ Also see "FDA Poised To Overhaul Distribution Of Consumer Medical Information" - Pink Sheet, 9 March, 2009., p. 35).

Mikulski said, "As we take a look at reforming health care and improving access, one of the things that we have to be able to do is get value for what we pay for, which also goes to the efficacy of pharmaceuticals, biologics and medical devices. What role will you play in the health care debate to give us ideas and recommendations on efficacy?"

"I very much look forward to being involved in health care reform efforts around these important issues and making sure that drugs, vaccines, diagnostics and devices are as appropriately used as possible to make a real and enduring difference in health in this country," Hamburg said.

Mikulski replied, "I hope you're at the table too and I hope FDA's at the table because I don't want ... what drugs the American people have access to determined by insurance company formulary gatekeepers. I would hope that it would be based on efficacy as well as safety so that a clinician when they were prescribing not only knows what is safe ... but also what has the greatest efficacy and therefore gets the most value for health care."

FDA's Interaction With Industry

There was some stark discrepancy among the senators on how Hamburg's public health experience would guide her leadership of FDA in terms of drug development and regulation. Hatch noted that the continuing staffing and facility upgrades at the agency should allow a Commissioner Hamburg to lead an agency focused on industry innovation.

"I think you can augment the safety and efficacy process for companies so that we can do more innovation than we have done in the past," Hatch said.

Conversely, Sen. Sherrod Brown, D-Ohio, said the possible commissioner should direct agency attention away from industry desires and toward public health, noting an experience from his former role on the House Energy and Commerce Subcommittee.

"I remember the FDA giving a presentation on the status of the FDA in the early Bush years. And what was so telling was that at the beginning of the hearing what they told us was that thanks to the FDA and other agencies, that U.S. drug companies market share in Europe had increased dramatically - as if that was the major function of the Food and Drug Administration," Brown said.

"I look to you and understand that your work in public health will not put that as the major priority - what the drug companies want. ... We've seen some of the same relaxation or indifference, if you will, to public health in last few years, and I know that your role at FDA will help us to answer that," Brown said.

Brown and Hatch were among several senators who expressed interest in working with Hamburg regarding follow-on biologics; legislation to establish an approval pathway is slowing wending its way through Congress (⁴ Also see "Follow-On Biologics Legislation Faces Tough Road Ahead; Momentum Stalled" - Pink Sheet, 27 April, 2009., p. 23).

If Hamburg does end up leading FDA as it implements a follow-on biologics pathway, the regulatory decisions by the agency will of course have financial consequences. It's just one of the ways - including approval standards in general and encouragement of personalized medicine - in which the agency will shape the health care landscape for years to come ("⁵ Also see "FDA and Health Care Reform: An Activist Agenda for the Agency" - Pink Sheet, 1 December, 2008.," The RPM Report, December 2008).

Congress is keenly aware of this impact and is putting the FDA commissioner nominee on notice that she will now have to consider it as well.

- Jamie Hammon (j.hammon@elsevier.com)

Commissioner Nominee Hamburg Questioned On FDA’s Role In Health Reform

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