After Abbott, A Tougher FDA Is Emerging : Targeting Device CEOs Gets Their Attention—and a Fix : FDA Approvals Chief Departs : Why Don't Device Firms Use Innovative Reviews? : FDA Abandons Internet Promotion Guidance

James G. Dickinson

December 1, 1999

10 Min Read
After Abbott, A Tougher FDA Is Emerging : Targeting Device CEOs Gets Their Attention—and a Fix : FDA Approvals Chief

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI December 1999 Column



James G. Dickinson


  • Targeting device CEOs gets their attention and a fix

  • FDA approvals chief departs

  • Why don't device firms use innovative reviews

  • FDA abandons Internet promotion guidance

The warm and fuzzy climate of FDA's regulatory relationship with medical device manufacturers may be turning a bit chilly. Initiated by the Clinton Administration's "reinventing government" program and the agency's own complementary "reengineering" initiative at CDRH, and fostered by the FDA Modernization Act (FDAMA), the atmosphere of friendly cooperation is looking bleaker in the wake of November's record-setting consent decree with Abbott Laboratories.

The $100 million decree exceeds the previous record of $61 million—also against a device company—dating from the 1993 C.R. Bard settlement. Abbott announced it was taking a $168 million charge against its assets to allow for lost sales and administrative costs it will incur in implementing the manufacturing and personnel changes required by the decree—including FDA's costs for verifying corrections.

There's always a great temptation to view such events as isolated occurrences, confined to their own particular set of circumstances. But that's not the way FDA's highest management is viewing the Abbott consent decree, FDAMA or no FDAMA.

What they're saying—though not for attribution—is that this case sends a signal to industry as a whole about the seriousness with which FDA views promises made to it by manufacturers within the inspection setting.

A senior official close to the Abbott case has told this reporter that Abbott could have gotten out of its GMP problems five years earlier for about $20 million, but that its management decided instead to "play hardball" with the agency, making promises it had no intention of keeping. In successive inspections of Abbott's in vitro diagnostics facility, promised corrections were found not to have been carried out. Although this lack of response was not unique to Abbott, FDA officials say privately that the company's management was especially tough to deal with.

The Abbott consent decree prompted FDA commissioner Jane Henney to make the first public statement of her term on an enforcement matter. "This action underscores FDA's strong commitment to the enforcement of laws designed to protect patients and consumers," an agency statement quoted her as saying. "These violations do not necessarily mean that Abbott's diagnostic products will harm patients, but the firm's failure to follow good manufacturing requirements decreases the level of assurance," she added.

What Henney calls the "level of assurance" is what other firms besides Abbott have been taking lightly, agency leaders say. It isn't enough that no patients are being injured by a company's failure to dot regulatory i's or cross regulatory t's—FDA's investigators have to be happy with a company's quality system. This toughening attitude comes at an odd time in FDA's history, when the Republican Congress has once again ratcheted down the agency's enforcement budget while earmarking increased funds for product approvals.

Under the agreement, Abbott is allowed to continue manufacturing and distributing diagnostic products that FDA agrees are "medically necessary." These include assays for hepatitis, retrovirus, cardiovascular disease, cancer, thyroid disorders, fertility, drug monitoring, and congenital and respiratory conditions. The company said the decree "does not affect Abbott's MediSense, i-STAT, hematology, or Murex products; the clinical chemistry products Abbott Spectrum, Aeroset, and Alcyon; or any other Abbott divisions or products." All other Abbott in vitro diagnostic devices could remain available for 30 days, in order to "permit users to standardize and obtain alternate test methods," FDA said in a statement.

The agency also recommended the use of additional quality control material (reagents used to help verify the proper functioning of test kits) made by other firms to ensure that Abbott's tests function properly. After 30 days, Abbott won't be permitted to make or distribute non­medically necessary tests.

"Abbott has agreed to comply with FDA's quality systems regulation for these products according to a schedule approved by FDA," the agency's statement said. "The firm has also agreed to pay $15,000 per manufacturing process, per day (up to a $10 million cap), for failure to adhere to that schedule." In addition, if the medically necessary products are not in compliance within one year, Abbott has agreed to pay another fine equal to 16% of the noncompliant products' sales revenues.

The consent decree requires Abbott's corrections to be overseen by an outside expert who will certify to FDA that corrections have been made. FDA will also reinspect Abbott's facilities to verify that the products have been validated and that the manufacturing processes conform to the quality system regulation. If the inspection does not reveal any significant problems, the affected products will be allowed back on the market, FDA said.

The decree states that, "Once corrective action is complete and Abbott has been allowed to resume manufacturing and distribution, the company will hire an independent auditor to conduct audit inspections of its in-vitro diagnostic device manufacturing operations at least twice a year for at least four years." The decree will still allow Abbott to export affected products as long as they meet export requirements outlined by the Federal Food, Drug, and Cosmetic Act.

When CDRH upped the ante last year in its war against medical device industry inattention to the new QSR, it elicited an unusually synergistic reaction from the industry itself. FDA's move involved redirecting its QSR warning letters from the customary recipients in companies to the highest management authority of all—in most cases, the chief executive officer. Philosophically and legally this made good sense, since the new regulation's systems focus involves multiple layers of company structures and directly scrutinizes the corporate culture for which CEOs are ultimately responsible.

The first of the new-style warning letters caught the eye of Nancy Singer, special counsel at the Health Industry Manufacturers Association (HIMA), who re- cognized the trouble they could cause.

Singer set about organizing an industrywide, self-help response that would capture and hold the commitment of highest management while advancing FDA's goal of establishing an effective systems approach to quality assurance and quality control. FDA was significantly motivated, Singer knew, by its resource limitations. The days of nit-picking, "gotcha" enforcement on a violation-by-violation scorecard approach had necessarily yielded to a partnership strategy under QSR—as embodied in the QSIT program, which practically dragoons industry management into active participation.

However, as FDA's flurry of warning letters showed, industry was not yet on board. Despite plenty of FDA letters, notices, and meeting presentations, the word had not permeated up all corporate structures.

Assembling a panel of 30 industry representatives in addition to HIMA's Bernie Leibler, Singer and Guidant Corp.'s Michael Gropp put together, with FDA input, a 14-page document titled Points to Consider When Preparing for an FDA Inspection under the QSIT Management Controls Subsystem. It was posted on HIMA's Web site in mid-September.

The document provides a brief history of the new QSR regulatory landscape and then focuses on FDA's primary concern and the source of its main current frustration: management responsibility. (During the first QSR inspections in late 1998/early 1999, 57 of 200 FDA-483 observations had involved management deficiencies or outright failures.) Of the top 10 deviations noted by FDA investigators, HIMA's document points out, management controls subsystems accounted for 40%.

The HIMA document stresses that responsibility belongs with top management, naming criminal-case examples that cited CEOs, presidents, executive vice presidents, QA vice presidents, production VPs, corporate regulatory affairs VPs, and general counsels. It also presents ways in which company managements should respond to FDA QSIT inspections. The document can be found on HIMA's Web site at

After six years at CDRH, director of device evaluation Susan Alpert, MD, moved to FDA's Center for Food Safety and Applied Nutrition (CFSAN) in October as director for food safety, joining another CDRH alumnus, former deputy center director Joe Levitt, who is CFSAN's director. In a statement, Levitt said Alpert's appointment "means FDA will be bringing a clinical perspective to all facets of its public health mission of ensuring that Americans continue to enjoy a safe food supply."

A successor to Alpert at CDRH had not been named as this issue went to press.

A panel of senior CDRH officials say they need to hear from industry on why more use isn't being made of innovative programs designed to speed reviews and free CDRH staff for more focused work. "We probably have the largest menu of options for submission we've ever had in the device program," outgoing Office of Device Evaluation director Susan Alpert told attendees at the Regulatory Affairs Professionals Society (RAPS) annual conference in Washington, DC. "We don't understand the reasons why people aren't taking advantage of the options available. Maybe we're not telling industry enough about how we think the programs work, about their benefits."

CDRH director David Feigal said one example of the problem is in third-party reviews. Although some 1200 devices are eligible for such reviews, he said, only 32 have been submitted for them, even though the process takes only half the time of a standard review. "You need to tell us what we can do," Alpert exhorted the RAPS attendees. "Why don't you use third-party reviews? We need you to communicate to us what we can do to make these programs more useful to you."

Expanded use of the alternative programs is important, said Alpert, because in the last fiscal year CDRH was essentially unable to further reduce review times. Preliminary figures, she said, indicate a reduction in 510(k) submissions along with a reduction in the amount of FDA review time and total review time. A total of 44 premarket approval (PMA) applications were approved, with FDA requiring an average of 9 months out of a total review time of 12 months. Alpert indicated that the agency is working on PMAs submitted in late 1998 and 1999, and that there were four modular submissions in the last fiscal year.

"We're proud of these numbers," Alpert said, "but they are flat from last year." With CDRH committed to meeting the FDAMA mandates of 90-day reviews for 510(k)s and 180-day reviews for PMAs, she said, it's necessary that the number of each coming to the agency be reduced through greater use of available options.

During a question-and-answer period after the formal presentations, one attendee said the special 510(k) has worked well in his experience, but the abbreviated 510(k) has been "a mess" because there are consensus standards that are in conflict with older guidances, and companies find that reviewers continue to turn to the guidances. In response, Alpert said the agency does not have the resources to read every guidance looking for conflicts with the consensus standards, and she asked for industry's help in pointing them out.

In other comments, Alpert said the Office of Device Evaluation recognizes industry's interest in reimbursement issues and would like to help the parties involved communicate with each other. She suggested that representatives of the Health Care Financing Administration be invited to meetings at which clinical trials are discussed so the trials can be designed to meet the needs of all parties and interests.

Office of Compliance director Lillian Gill told the group that her priorities for next year include evaluation of the QSIT and MRA programs, various grassroots initiatives, Y2K, HACCP, and more advertising and promotion guidance.

FDA has abandoned its efforts to develop an agencywide Internet advertising and promotion guidance because of the Web's "constantly evolving nature," Center for Biologics Evaluation and Research labeling policy associate director Toni Stifano told an industry meeting in Washington, DC. Speaking at the RAPS annual conference, Stifano indicated that the agency still holds a "significant interest in the multifaceted utility of the Internet." She said the agency's top management decided to continue to apply existing laws and regulations with regard to enforcement actions on a case-by-case basis.

According to Stifano, FDA will now focus its Internet enforcement on three areas: unapproved products, health fraud, and prescription drugs sold without a prescription.

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