HHS Secretary-nominee Michael Leavitt vowed to uphold the trustworthiness of the FDA "brand" in Jan. 18 testimony before the Senate HELP Committee.

FDA, National Institutes of Health and Centers for Disease Control & Prevention are three HHS brands that have "earned the public's trust," Leavitt noted during his confirmation hearing.

"To millions of people, these brands are seals of quality, safety and best-in-the-world research," he said. "If they lost their reputations, they would take years to recover."

Leavitt's comments respond indirectly to criticisms FDA encountered in late 2004, when policy concerns surrounding adverse cardiovascular events, pediatric use of antidepressants and a flu vaccine shortage riveted the public's attention.

Some of those issues, which generated congressional hearings late last year, have invited stakeholder debate on a variety of potential corrective actions.

In the Dec. 1 issue of the Journal of the American Medical Association, editors stressed the need for an agency independent of industry to ensure conscientious and effective postmarket surveillance (¹ 'The Gray Sheet' Dec. 6, 2004, In Brief).

At the Jan. 18 hearing, senators urged Leavitt to see that a permanent FDA commissioner is found as soon as possible, referring to "an agency in crisis." Asked if President Bush would pick a commissioner by the end of January, Leavitt replied: "My sense is that it will happen soon."

HELP Ranking Minority Member Edward Kennedy (D-Mass.) suggested that he will insist on a candidate without ties to FDA's regulated industries. Kennedy adopted the same tack throughout the selection process that led to the appointment of Mark McClellan, MD/PhD, now CMS' administrator.

"There are a number of enormously gifted and talented people outside the industry that can do the job," Kennedy stated.

Since McClellan's departure in March 2004, the agency has been headed by Acting Commissioner Lester Crawford, DVM/PhD. Largely in response to the eye-opening Vioxx and antidepressant incidents, Crawford authorized a CDER-requested Institute of Medicine study of the drug safety system.

For its part, AdvaMed and the device sector have steered clear of the controversy over drug adverse events by asserting fundamental differences between the two FDA-regulated industries.

AdvaMed opposes the JAMA editorial's assertion that postmarket surveillance of drugs and devices alike require major restructuring and more rigorous implementation.

The trade association observes that nearly all device recalls begin with the firm, not with an FDA action. Such flaws typically can be resolved with relatively easy design or manufacturing changes, AdvaMed says. Problems experienced with drugs often relate directly to the compound and cannot be fixed without chemical tweaks (² Also see "AdvaMed Distances Devices From Proposed Postmarket Surveillance Reforms" - Medtech Insight, 3 January, 2005., p. 6).

The responsibility of promoting AdvaMed's image and, to a certain extent, the industry's image at large falls to VP-Public Affairs Mary Anne Hansan, who joined in November. Hansan brings a "consumer branding and safety communications" background.

Hansan's FDA counterpart, attorney Sheila Walcoff, was appointed associate commissioner for external relations last fall. She replaced Peter Pitts, who left in June for public relations firm Manning Selvage & Lee. At FDA, Pitts actively championed a proactive "branding" policy.

One day after its confirmation hearing for Leavitt, the HELP Committee endorsed him in a unanimous (20-0) vote. The Senate Finance Committee ultimately has jurisdiction over Leavitt's nomination and the responsibility to report it out of committee. Although Finance held a Jan. 19 hearing on Leavitt, the committee has yet to vote for his confirmation.

The former Utah governor's opening statement before Finance contained a single, oblique medical device reference. "Americans deserve the healthcare of the 21st century. We've earned it. That includes modern medical technology, modern information technology, and modern, consumer-focused delivery systems." Citing the trend toward "personalized medicine," Leavitt envisioned "a world in which a doctor can write a prescription on a handheld device and transmit it to the patient's pharmacist, who can start filling it before the patient leaves the doctor's parking lot."

In Critical Climate, Leavitt Pledges to Maintain FDA “Brand” Integrity

More from Archive

More from Medtech Insight