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An MD&DI  March 1998 Column

WASHINGTON WRAP-UP

Agency statistics indicate that FDA will refocus its enforcement activities in 1998.

James G. Dickinson

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FDA is likely to face its tightest budget ever in 1998, with a 12.2% reduction in money for medical device "field activities." This will most likely mean fewer routine GMP inspections and briefer inspections when they do occur, according to device compliance director Lillian Gill.

Ironically, the severe budgetary restrictions have come just as the agency was beginning to reverse its deregulatory trend of the past four years. Because of this, the 1998 budget is likely to bring only a pause as FDA refocuses itself and finds other, less traditional ways of increasing its pressure on industry to be in regulatory compliance.

The trend toward more enforcement is seen in agencywide statistics compiled by the Division of Compliance Management and Operations in FDA's Office of Enforcement. They show that although the number of overall plant inspections has declined 9% over the last 10 years—3473 establishments of all kinds were inspected in 1988, and inspections in intervening years have varied from a low of 2734 in 1990 to a high of 3602 in 1996—the number of warning letters increased in 1997 for the first time in five years, up 9% to 1140. Seizures increased from 36 to 46, and the number of prosecutions rose to two from FY 1996's 10-year low of one.

In comparison to the statistics for agency inspectional activities in all its areas of jurisdiction, inspections of violative medical device establishments rose by almost 9% during the last fiscal year to 1693, compared to FY 1996's record low of 1548.

FDA's total product recalls (including food) rose significantly in FY 1997—up nearly 17% to 3619 from the previous year's 3012, which in turn had risen from FY 1995's 3004. The 10-year graph of agencywide product recalls since FY 1988 shows substantial upward movement if intervening peaks and valleys are blended—FY 1997's 3619 is a 237% increase over FY 1988's 1526.

Medical device statistics fit the same pattern for the nine-year period through the end of FY 1996. Only in the 10th year, 1997, do the number of device recalls deviate from FDA's overall 10-year pattern. There were only 941 medical device recalls in 1997, compared to 1996's 1242, 1995's 1237, and 1994's 1443.

High-level FDA enforcement officials are disturbed by the overall rise in product recalls that has occurred at the same time that the number of plant inspections has declined. Since the agency's policy is to homogenize its programs as much as possible for consistency—despite indications from Congress in the FDA Modernization Act of 1997 that medical devices should be treated differently from other product categories—FDA's enforcement strategies will probably reflect this concern for the overall picture rather than CDRH's recent (and possibly aberrant) experience.

Device companies' ability to cite a product's FDA approval to escape liability in state courts came a step closer to being ended in December. The agency published a proposed final rule that significantly elaborates on the Supreme Court's decision last summer in Lohr v. Medtronic. FDA concludes that common law tort claims ought not to be preempted by a manufacturer's having received or followed 510(k) clearance, an investigational device exemption (IDE), premarket approval (PMA), an agency proposal of modifications to IDE or PMA submissions (which "do not relieve the applicant of its ultimate responsibility"), or general labeling and GMP regulations.

The preamble to the proposed rule suggests that even specific FDA requirements imposed on a particular device should not lead to preemption unless common law rules differ from or add to the FDA requirements. Lawyers suggest that juries be carefully instructed on the distinctions between FDA requirements and state or common law to obviate confusion when they hear such tort claims.

The Lohr decision applied only to 510(k)s, and several lower courts have since maintained that IDEs and PMAs preempt personal injury claims. On April 19, 1997, the Supreme Court asked the Office of the Solicitor General for the government's (i.e., FDA's) views on petitions for certiorari (requests for review) in some of these cases. FDA's proposed rule of December 12, 1997, firmly states that only in rare cases should FDA regulations or actions deprive an injured patient of full access to a court trial.

"FDA believes," the proposal says, "that its general regulatory review and approval processes provide a significant measure of protection against the marketing of dangerous or defective medical devices. FDA does not believe, however, that those processes can guarantee the safety of such devices. Accordingly, compliance with general FDA requirements should not broadly preempt state common law remedies, which provide an important (and frequently the only) mechanism for persons to seek redress for injuries resulting from defective medical devices."

The fewer cases FDA brings in court, the more likely it is to lose. At first glance, this is the message conveyed by different sets of statistics covering each end of the litigation pipeline—but a senior lawyer in FDA's Office of Chief Counsel, who wished to remain anonymous, maintains the impression is misleading.

The number of prosecutions brought by the agency has dropped sharply, from a high-water mark of 52 in FY 1992 to just 1 in FY 1996 and just 2 for FY 1997—numbers produced in the Division of Compliance Management and Operations, Office of Enforcement. In contrast, more parties are suing FDA. When combined, the two kinds of cases—fewer offensive and more defensive—seem to show a higher than customary number of FDA losses in court.

This picture is further muddied by the long lag times between close of argument and decisions handed down, not to mention any appeals. For example, of 34 clear-cut decisions handed down in FDA cases in FY 1997, many of which were several years or more in the making, FDA lost six (two are on appeal). This is an 18% failure rate, compared with 14% in FY 1996 and 15% in FY 1995, when there were about twice as many decisions and a much higher ratio of FDA "offensive," as opposed to "defensive," actions (FDA brought 36% of the cases in FY 1997's decisions, 52.5% in FY 1996's, and 54% in FY 1995's).

Of the six cases FDA lost in FY 1997, the agency brought only two of them; similarly, of the eight lost in FY 1996, FDA brought only two, and they were essentially the same matter (U.S. v. Burzinski, the Texas oncologist who dosed his patients with an FDA-unapproved drug he developed himself). Of the seven cases lost in FY 1995, none were brought by FDA.

CDRH reengineering, bolstered by its codification in the Modernization Act, is on a fast track, especially in the PMA/IDE and 510(k) processes, CDRH officials told a FDLI conference on December 9 in Washington, DC. Among the innovations about to be unveiled is a new PMA review process for high-impact, high-risk products that will cut PMA decision time, said Kimber Richter, deputy director of the Office for Device Evaluation. This new product development protocol process involves having FDA and the sponsor meet before the review begins and commit to a design and manufacturing plan and a design and testing process. Summaries are to be reviewed by FDA within 30 days and protocols within 120. Progress reports are to be turned around within 30 days of submission.

A modular review process is also being considered, Richter said, so that as each preclinical piece of information or each clinical study is completed, it can be submitted for review. The reviewed components would fall into an overall "PMA shell" so, when final clinical trials are completed, most of the PMA review is already finished.

Another PMA process improvement CDRH is working on is an interactive final labeling review. Under this process, CDRH would work with manufacturers either in meetings or conference calls to reach final labeling agreement as quickly as possible. Richter also plans to eliminate many of the rereviews now conducted on labeling after it has already been printed. PMA reviews for some of the more routine devices can also be streamlined to cut review time, she added.

CDRH improvements under its proposed 510(k) paradigm were expected to be ready by February 20, said Phil Phillips, CDRH science and regulatory policy deputy director. These included developing a special 510(k) for modifications to marketed Class I and Class II devices using FDA's earlier guidance flowchart in "When to Submit a 510(k)."

This special 510(k) does have limitations, Phillips admitted—it can't be used if the change affects the intended use of the product or changes its basic scientific technology. Under the special 510(k), firms will assess the modification in accordance with design control provisions and, if it conforms, a declaration of conformity can be submitted. The agency expects to review these submissions within 30 days of receipt, Phillips said.

The new paradigm will also allow manufacturers to submit an abbreviated 510(k) if they intend to market a new Class II device (or a reserved Class I device subject to review as outlined in the Modernization Act). In this scheme the device will be subject to special controls or recognized standards. Use of summary information and declarations of conformity will lead to thinner submissions, Phillips said, and faster review of the abbreviated 510(k)s.

Device sponsors will still bear the burden of convincing FDA that the "least burdensome means of evaluating effectiveness" are adequate, CDRH director Bruce Burlington stated in December during a satellite-TV session on this and selected other provisions of the Modernization Act. Cosponsored by FDA and FDLI, the TV presentation's panels were organized to spread the center's views on several subjects needing immediate attention according to the Modernization Act.

At the presubmission conferences made available by the new law, Burlington said, industry can expect ODE reviewers to ask to be shown why the advance agreement on each IDE and PMA application should not subject the proposed product to the strictest, most scientific approach. Burlington noted that this will usually mean that clinical trials with the device will be required.

U.S. Surgical Corp.'s vice president Lou Mazzarese was anxious to point out from the studio audience that the alternative allowed by the statute is not "low-quality science" but rather some type of research different from costly clinical trials. However, Medtronic vice president Charles Swanson, who was on the panel with Burlington, agreed that the sponsor must justify the method of evaluation. The other industry representative on the panel, Cook Group vice president Stephen Ferguson, noted that even apart from that issue, sponsors will have to be well prepared if they are to use the meetings with FDA to achieve any sort of binding agreements on the form and substance of device submissions.

A viewer sent a faxed query about an awkward possibility, namely, what happens if an advisory committee concludes that the preparation and negotiation have led to a flawed sponsor-FDA agreement. This is not an idle scenario, since one panel did just that in February 1996, rejecting a statistical method that FDA and the manufacturer had found adequate. ODE director Susan Alpert responded that the meetings will offer "advice, and we'll have to weigh it."

Gerry Prud'homme of the law firm Hogan & Hartson (Washington, DC) asked whether the Modernization Act's demands will be disruptive. Burlington said that Congress "gave us a lot to do, and very clearly expects us to do it in a tight time frame." His most sanguine analysis, though, described the statute as "cementing changes we've made in the last couple of years and encouraging more."

CDRH policy deputy Joe Levitt implied that he foresees no problems in complying with the act, asserting that nothing in it conflicts with CDRH's reengineering initiative and that in large areas the law and the initiative are complementary.

Levitt and ODE's Phil Phillips reported brisk movement on several of the statute's other mandates. FDA was required by Congress to release a list by January 20 identifying which Class I and II device categories would be exempted from the 510(k) requirements—although none of them, Levitt was quick to point out, is or will be exempt from GMP regulations.

The center planned to publish by February a list of the consensus standards that FDA will recognize in 510(k) reviews—a "living list," interjected Don Marlow, director of the Office of Science and Technology, to be revised regularly and to follow the thinking of the American National Standards Institute.

Asked by Mazzarese about the new law's compromise section on limiting review to labeled indications, Phillips intimated that the center director would be sparing in using his authority to modify labels with statements about unapproved indications.

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