FDA Action Plan to Improve Regulation of Biologic Devices

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An MD&DI July 1999 Column

WASHINGTON WRAP-UP

CBER will harmonize its policies with CDRH.

James G. Dickinson

FDA's Center for Biologics Evaluation and Research (CBER) in April announced a major "action plan" by which it intends to minimize or eliminate inconsistencies between itself and CDRH in the handling of devices that are also biologics.

A driving force for this is the FDA Modernization Act of 1997, which directed the agency to improve its relationships with regulated industries. Other factors motivating CBER are input it has received from its external constituencies and a desire to compare more favorably with CDRH, which is producing impressive results from its ongoing reengineering initiatives.

The action plan calls for implementation of a "transparent process" for consistently applying regulatory and administrative requirements to the review, inspection, and compliance follow-up of biologic devices. It sets a deadline of September 30 for identifying biologics that should have device inspection methods (e.g., tines, prefilled syringes, and injectors) and for determining if any deviations from CDRH policies can be justified. By October 31, the Team Biologics Operation Group is to implement agreed-upon recommendations and any necessary training of both FDA and state inspectors is to begin by April 1, 2000.

The action plan also demands improved communications, both between the center and industry and between CDRH and CBER. Stakeholder meetings were held in June to get outside input on achieving this objective, and an FDA assessment of progress made is slated for next April.

CBER's action plan also targets device-review performance within the biologics center, acknowledging that there have been "problems" in processing applications by their legal deadlines. The intent is to identify and implement workload-reduction measures such as guidance development and to harmonize the center's policies with CDRH by October 1.

They say there's no turning back the clock, but in a real sense that's what FDA commissioner Jane Henney is doing in her reorganization of the commissioner's office, which was announced to agency staff in April. Almost everything that David Kessler did in the office is now being undone, and the day-to-day operational power of the agency is being returned wherever possible to the various program centers and to the field organization. There is even a subtle restoration of the policy-guiding role of the Office of Chief Counsel, the downgrading of which is claimed by most former FDA chief counsels to be a factor in the recent, unprecedented run of courtroom losses suffered by the agency.

In addition, one Kessler innovation, the Office of Special Investigations, headed by Jack Mitchell, is being abolished. This office caused a good deal of managerial paranoia because its function was never clearly communicated; Kessler used it as a listening post for a time, trying to gather intelligence about employee perceptions of possible wrongs committed by other employees, but soon grew tired of its "interference" and stopped heeding its advice.

In the April 22 memo to affected employees, Henney said she approached the reorganization with four goals:

These goals come straight out of Henney's preappointment discussions on Capitol Hill and her confirmation hearing. They were parlayed to key lawmakers before being announced inside FDA, and reportedly met an enthusiastic response: "This is exactly what we hoped you'd do," one legislator reportedly said. In that one comment, Henney probably divined that there existed no great support for the Kessler legacy.

The most noticeable impact of the reorganization—which has just taken effect following negotiation with the FDA employees union and some budgetary reprogramming from Congress—will likely be the ascendancy of newly titled senior associate commissioner Linda Suydam, who has been given responsibility for coordinating all activities within the Office of the Commissioner. Suydam will also directly supervise the following entities: the Chief Mediator and Ombudsman staff, Office of the Executive Secretariat, Office of Public Affairs, Office of Orphan Products Development, the Internal Affairs staff, the Advisory Committee Oversight staff, and the Office of Tobacco Programs. During the Kessler years, Suydam played a key role in CDRH management.

Henney assumes direct line-reporting contact for all of the center directors, who previously reported through deputy commissioner Michael Friedman (who has no specific responsibilities in the reorganization other than being Henney's second-in-command). Newly appointed associate commissioner for regulatory affairs Dennis Baker, who heads field enforcement, will also report directly to Henney.

Additional personnel moves include the appointment of acting deputy commissioner for policy William Hubbard to the post of senior associate commissioner for legislation, policy, and program planning, where he will oversee the offices of policy coordination, legislative affairs, and planning and evaluation. Deputy commissioner for external affairs Sharon Smith Holston will have her title changed to deputy commissioner for international and constituent relations, and deputy commissioner for management and systems Robert Byrd will retain his present responsibilities. Holston's and Byrd's office titles will be eliminated when they leave those positions, which will be renamed "associate commissioners" instead of "deputy commissioners."

One effect of the reorganization will be to relocate some 130 positions out of the Office of the Commissioner—90 of them into the centers and the remainder elsewhere in the agency.

In April, FDA approved a new imaging device by TransScan Medical Inc. (Ramsey, NJ) that will help radiologists determine, when mammogram results are ambiguous, whether a woman should be evaluated further. The T-Scan 2000 "has the potential to reduce the number of negative biopsies," FDA says, "and increase the identification of women who should be referred for early biopsy."

In a talk paper, FDA said the T-Scan uses a handheld scan probe placed on the breast to evaluate certain suspicious areas detected on the mammogram. The probe is connected to a computer, which displays an image of the involved areas of the breast. The T-Scan images are based on differences in the electrical impedance between malignant tumor tissue and the surrounding normal tissues. The device measures impedance by passing a small electrical signal through the body and displaying on a computer the result from sensors in the probe contacting the breast. The computer image contains bright spots where the impedance values are consistent with a possible malignancy.

As a condition of approval, TransScan Medical is being required to conduct a postmarket study on the effects of hormonal changes during the menstrual cycle on the device's ability to detect and distinguish among breast abnormalities.

A just-updated, three-page FDA compliance policy guide (CPG160-800) on year 2000 (Y2K) computer compliance gives agency field investigators detailed instructions on what enforcement actions should be taken when Y2K noncompliance is encountered during inspections. Mere noncompliance is not to be listed on the FDA-483, the guide says, but "observations regarding specific process or product deficiencies related to the Y2K problem should be listed."

Likewise, for medical devices, if a firm initiates a correction or removal to address a Y2K problem and that action is intended to reduce a risk to health, "then the firm must report their action to FDA . . . regardless of whether or not there has been a malfunction related to Y2K," according to the guide. The document is available at http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg160-800.html.

Phillips Medical Systems of Shelton, CT, conducted a Class II recall (indicating serious but reversible health consequences) of 1086 Integris x-ray controls and generators on April 6 because they were found to be defective under their FDA performance standard. According to the April 21 FDA Weekly Enforcement Report, the defect occurs when the system is driven to a maximum entrance exposure rate and the source-to-image-receptor distance is reduced while exposures continue to be made. In this manner of operation, the output may exceed 10 rd/min because the software will not update the output until the exposure control is released.

FDA has posted its newest roster of accredited third parties authorized to review selected 510(k)s that would otherwise be submitted to the agency for review. Devices eligible for third-party review are limited to those listed on FDA's Web site.

The latest list of accredited reviewers, with contact information and device panel categories, is as follows:

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