Also: Speedier IDEs and PMAs

James G. Dickinson

Like all previous FDA commissioners, Jane Ellen Henney has had little experience with medical devices. But if the Clinton nominee is confirmed by the Senate, she will be the most Washington-savvy commissioner of the past 30 years. Should she be receptive to the medical device industry, she will have the tools to be a highly effective commissioner from the industry's perspective.

For the time being, however, Henney's reputation with industry presents a hurdle for her to overcome. After all, she was responsible for superintending—though not originating—the moratorium on silicone-filled breast implants in 1992 and the controversial Temple report that severely criticized FDA's device-review policies. Much of the strain between FDA and the device industry stems from those two episodes.

Most likely, Henney will not directly address any residue of bad feelings that remains. Her philosophy is to make her mark through delegation. Hence, any outreach to industry will probably come through the Center for Devices and Radiological Health (CDRH) and its director, Bruce Burlington.

Henney, a physician whose main professional interest has been cancer, is more familiar with the ways of Washington and FDA's bureaucracy than any of her predecessors since the last career bureaucrat to be appointed FDA commissioner, James L. Goddard (1966–1968). She earned her degree from the Indiana University School of Medicine and then spent three years in postgraduate medical training, including an oncology fellowship at M. D. Anderson Hospital and Tumor Institute (Houston). In 1976, she began nine years of federal service holding steadily more responsible administrative positions at the National Cancer Institute (NCI), where she built her reputation for fact-based, objective decision making and management. Now 51, Henney became deputy director of NCI at age 32 and later served seven years at the University of Kansas School of Medicine as interim dean, vice chancellor for health programs and policy, and acting director of its Mid America Cancer Center. She added two more years of federal service in 1992, when David Kessler tapped her to be deputy commissioner for operations at FDA. In 1994, Henney took a position as vice president of the University of New Mexico's Health Sciences Center.

Henney thus has more than 11 years of experience in the gargantuan Department of Health and Human Services, which houses FDA and NCI. The fact that she not only survived but thrived in that environment—to the point where she is eager for a third stint—speaks to her high likelihood of success as FDA's 17th commissioner and first woman at the helm.

FDA is, however, a different agency from the one Henney left. It has been straitened by successive budget cuts, sobered by a deep internal cultural change that makes it more of a partner to industry than it had been when she was there with Kessler, and convulsed under new directives from the FDA Modernization Act, which will continue to reshape the agency for years to come. As Biotechnology Industry Organization executive director Carl Feldbaum told the Washington Post on learning of Henney's nomination, "This is as important a nomination as the FDA has ever had in its history."

If confirmed, Henney will face a far tougher job than the one Kessler took. His nomination, the first decided by the Senate since the post became a presidential appointment, slipped easily through an uninterested chamber, literally in the middle of the night. But because his tenure later became so controversial, especially in industries like medical devices that resented his beefing-up of enforcement, the job and the agency as a whole are now under much more scrutiny.

The key expression of that scrutiny is the Modernization Act, which holds the commissioner and the agency more accountable, and requires more periodic performance reports to Congress, than ever before.

Although Henney was attacked in a Wall Street Journal article on June 26, 1998, by former FDA director of biotechnology Henry I. Miller as "the wrong choice" because she "showed no sign of perceiving the need for reform" (their tenures at FDA overlapped by one year), in June Henney informally told the lawmakers who will vote on her confirmation that implementing the Modernization Act is her highest priority.

Miller's article also accused Henney of being "unapproachable and intransigent" and "a true believer in arrogant, intrusive, damn-the-expenses government regulation." Others who know them both, however, say Miller may have had a chip on his shoulder about FDA management in general, if not Henney in particular. Although nobody in a government agency like FDA achieves much without drawing criticism from some quarter, even Henney's defenders acknowledge that she can be "reserved" and that she possesses "strong opinions." On the other hand, Linda Suydam, Henney's close confidante at the University of New Mexico, now FDA associate commissioner for strategic management, says Henney "is a person that people like working for." That jibes with Henney's philosophy of delegation. When she joined Kessler at the agency, she set about strengthening its five main program centers so they would operate with as much autonomy as possible.

Henney's views on enforcement are unknown. During her round of preliminary visits to senators and representatives in June, the subject never came up. According to an HHS official who accompanied Henney on her visits, the lack of interest in this topic was surprising. Questions were limited to her stance on Modernization Act implementation and the breast implant issue.

However, the question of enforcement is likely to be raised during the confirmation hearings to be convened by Senate Labor and Human Resources chair James Jeffords (R–VT). Jeffords indicated in a key speech to the Drug Information Association in June that he would have preferred the nomination of acting commissioner Michael Friedman. He declined to meet with Henney until he had carefully studied her record; his staff later let it be known that the confirmation hearing was not an urgent issue for Jeffords and might be months away.

The FDA enforcement issue that has grabbed congressional attention is postmarket surveillance, especially of drugs, following the recent crop of market withdrawals and warnings (Fen-Phen, Posicor, Duract, Propulsid) due to toxicities that were unsuspected when FDA approved the products. Postmarket surveillance, however, is also an issue for medical devices—especially since the latest Clinton administration budget for FDA cut device field activities by 12.2%, affecting, among other things, preapproval inspections and export certificates.

From industry's point of view, in an ideal world FDA's entire enforcement budget would be redirected to product approval–related activities. As a result, industry is not likely to press senators into asking Henney lots of hard questions about her enforcement intentions. Yet the senators will be sensitive to constituent worries that the reliability of food, drugs, and devices may have been compromised by diminished FDA surveillance and enforcement.

Perhaps June's meeting foreshadows a relatively smooth—if delayed—confirmation process, despite the administration's apprehensions and Jeffords's apparent skeptical disdain. If so, all signs indicate that there will be no surprises for medical device firms from Henney as FDA commissioner.

To further expedite the review of investigational device exemptions (IDE) and premarket approval (PMA) submissions, in June FDA's Center for Devices and Radiological Health proposed three new models for the development and review of Class III medical devices. The models are expedited reviews (for devices with a major public health effect), standard reviews (for most other devices), and streamlined reviews (for devices that are well understood by both the sponsor and the agency).

A major feature of the new Medical Device Development Process (MDDP) will be greater interaction between sponsor and agency earlier in the development process than is now customary, FDA said in a draft guidance. MDDP will also place greater reliance on up-front agreements on requirements and will ensure review flexibility by allowing product development to be customized to fit the device and the indication. The device's pre- and postmarket life cycle will be considered throughout the process. The process will be modular—the application and administrative review file will build over time as the major components of the application are reviewed and approved.

CDRH said it is giving special focus to PMA reviews under MDDP, with the objective of getting final review decisions made within 180 days.

The center defined each IDE/PMA review track as follows:

Expedited MDDP. The highest priority and highest level of interaction will be given to products intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions, that represent breakthrough technologies or technologies for which no approved alternatives exist, or that offer significant advantages over existing approved alternatives, or the availability of which is in the best interest of the patients (see PMA/ 510(k) Expedited Review Guidance for Industry and CDRH Staff at http://www.fda.gov/cdrh/modact/expedite.html).

Standard MDDP. Most PMA devices will proceed through the standard track, which will include early meetings to reach agreement on an overall development plan and determine milestones.

Streamlined MDDP. PMA devices that represent a mature technology and that are well understood by both the developer and the agency will be included in the streamlined track (http://www.fda.gov/cdrh/pmat/streampmat.html). These include product types for which there is either a review guidance or substantial prior FDA review history with prior panel review as appropriate. FDA will develop guidance for the format and content of these products' PMA applications and their labeling.

FDA said that for all PMA tracks, CDRH will also expand the use of real-time reviews (http://www.fda.gov/cdrh/ode/realtim2.html) and schedule PMA closure meetings with applicants to reach agreement on final labeling and resolve outstanding issues in a timely manner.

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