Medical Device & Diagnostic Industry Magazine
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James G. Dickinson

Mid-March was the last chance for the medical device and biotechnology industries to steer FDA reform legislation in their favor and realistically expect passage this year.

The industries' Herculean efforts to avoid being jostled aside by Capitol Hill's higher priorities were aided by a promise from Senate majority leader Robert Dole (R­KS). If Senator Nancy Kassebaum (R­KS) could report her comprehensive reform bill (S. 1477) out of her Labor and Human Resources Committee during March, Dole told Health Industry Manufacturers Association (HIMA) president Alan Magazine, he would find floor time to discuss it in April.

Magazine and a few HIMA members met Dole in New Hampshire during presidential primary campaigning, and the Republican candidate "showed more understanding of device issues than I expected," Magazine said later. Despite gathering gloom about whether major FDA legislation could pass with so little time remaining in the congressional calendar, Magazine was heartened that medical device issues had such high visibility.

"It looks like it's picking up a head of steam," Magazine told this writer at the end of February, speaking of Kassebaum's bill. "There are indications that the congressional leadership wants to be able to show that it really can legislate, and this may be the bill it wants to move through."

Magazine's organization had a major role in reversing a movement that was developing against FDA reform among patient and disease organizations. HIMA had presented a 200-group petition to counter earlier criticism of Kassebaum's bill by the 57-member Patients' Coalition.

HIMA was not the only organization trying to push FDA reform through Congress. The Medical Device Manufacturers Association (MDMA; Washington, DC) joined these efforts, working mightily behind the scenes to sensitize both Republicans and Democrats to the industry's concerns about its very survival. In a departure from HIMA's strategy, the aggressive small-company-advocate MDMA emphasized single-issue legislation instead of overall reform, switching most of its attention to medical device reform on the House side, where four narrowly focused, separate FDA reform bills--devices, human drugs, veterinary drugs, and biologics--were incubating. While it was pushing FDA-knocking initiatives with the Republicans, MDMA was also pursuing a harder bipartisan course.

Even though the Republicans have working majorities in both chambers, they could not bulldoze over any minority objections; there would be no time to do so. Fastest passage could be achieved only by genuine, broad consensus, the only assurance of a presidential signature.

Even so, with time running out, there was much diversity in objectives, even among Republicans. For example, Kassebaum firmly maintained that FDA should not be forced to approve product applications that had been reviewed by outside contractors; she felt the agency should be allowed to elect to do so, and Senate minority leader Edward M. Kennedy (D­MA) strongly backed her. Was compromise possible? And, if so, could her bill's device provisions be blended with a device-specific House bill if pharmaceutical-sector dissent threatened to drag down the whole enterprise?

These and myriad other issues, large and small, were boiling as this column went to press. In February, Magazine said that, although the situation was changing hourly, device legislation had a good chance of reaching the president's desk this year, and put the odds somewhere between 60-40 against and 50-50. "It's a real shot," he insisted.

MDMA counterpart Jeff Kimbell initially agreed. But by the beginning of March, neither was sounding very optimistic.

Meanwhile, a 17-witness House Commerce health and environment subcommittee hearing was held on February 27 without even a bill to focus on, a move that cynics called empty posturing by lawmakers anxious to justify their industry PAC contributions. Witness after witness repeated well-aired criticisms--many voiced previously at a February 22 Kassebaum hearing--of FDA's past performance across a wide front of responsibilities.

However, it must be said that FDA's internal reform efforts have been impressive, especially with regard to the pharmaceutical industry, which has benefited from user fees. By adroitly networking these successes around Washington, FDA commissioner David Kessler blunted much of the earlier impetus for drastic overhaul of the agency.

Even National Medical De-vice Coalition president Wayne Barlow, CEO of Wescor, Inc. (Logan, UT), who had once been quite bitter in denouncing FDA's record, was thrown into a "yes, but" posture in a February news release, saying, "Though we have witnessed a change in recent months at the FDA because of increased congressional scrutiny, there is a fear in industry that without lawful change, circumstances may revert to the way things were done before 1995."

That's at least a tacit admission of tolerable improvement. And FDA is promising more to come.

National Medical Care, Inc. (NMC; Rockleigh, NJ), is staring at a federal indictment based on events that began in Ireland in 1990. Parent company W. R. Grace & Co. (Boca Raton, FL) announced in February that its dialysis device subsidiary had received a target letter from the U.S. attorney in New Jersey in connection with a grand jury probe.

The long-standing criminal investigation appears to be centered on NMC's submissions to FDA after the company obtained release, in January 1992, of an agency import detention order issued a year earlier against machines from its Dublin factory. Agency inspectors had found good manufacturing practice (GMP) violations during a routine investigation. These underlying deficiencies were described by Center for Devices and Radiological Health deputy director of compliance Philip Frappaolo as Situation I (most serious).

Ed Berger, NMC government affairs vice president, acknowledged that "the only place to look is at the integrity of our documentation." The company had already responded to a number of subpoenas demanding its files, he said. A target letter indicates the serious likelihood that an indictment will be handed up.

Berger, however, said that the letter was based on "a very old, very stale incident." The company has not decided exactly how to convince prosecutors to drop the case, he said, but "we're going to keep going till we've set them right."

NMC has had plenty of other regulatory problems, but W. R. Grace spokesman Chuck Suits said that the GMP issues seemed totally resolved when the company received a letter from FDA in December 1995 indicating that all of its manufacturing facilities were cleared. FDA had made a multisite inspection sweep earlier in the year because, as Frappaolo explained later, the agency had looked at NMC's corporate philosophy and decided that it was fostering a "band-aid" approach; this called for compliance scrutiny companywide. In 1993 and 1994, NMC had serious deficiencies at plants in Texas and Mexico. Even now, other federal grand juries in Massachusetts and Virginia are hearing about company matters unrelated to its device manufacturing.

The prosecution comes at a sensitive time for W. R. Grace, which just announced an agreement to sell NMC and its liabilities to a European company, Fresenius A.G. (Oberursel, Germany), for around $4 billion. However, Suits said the probe was disclosed earlier and the deal is unaffected. FDA, on the other hand, may be hoping that the Department of Justice will give it a fresh corporate scalp to take to congressional discussions about the advisability of deregulation and third-party review.

The case follows other, unrelated prosecutions in which C. R. Bard, Inc. (Mentor, OH), paid $62 million in fines for illegal conduct with cardiac catheters; Warner Lambert Co. (Morris Plains, NJ) was forced to pay out $10 million after admitting that stability failures were left unreported; and Ortho Pharmaceutical Corp. (Raritan, NJ) paid $7.5 million while pleading guilty to obstruction of justice.

Although FDA participates enthusiastically in international harmonization discussions with the European Union (EU), it foresees a long "confidence-building" phase before it will sign a mutual recognition agreement (MRA) that would give full credit to EU product approvals and GMP enforcement, Mid-Atlantic Region deputy director Joe Phillips told an industry meeting in Scottsdale, AZ, in February.

MRAs differ from memoranda of understanding (MOUs), which FDA has with many governments, in that MRAs cede agency authority to the other government, while MOUs allow FDA to reserve that authority; bothencourage the parties to work together.

FDA wants to find the answers to many questions about EU procedures before determining whether regulatory equivalence exists to a sufficient degree to permit an MRA, Phillips said. For example: Does the EU regimen provide the ability to cover inspections of regulated facilities, enforce laws and regulations, remove violative products, collect and analyze samples, avoid conflicts of interest, and conduct postmarket surveillance? And what if a firm refuses an inspection?

Phillips said that both the EU and Japan have requested MRAs with FDA, and that these requests have attracted the interest of both the State and Commerce departments. "We need an assurance that an MRA would provide the same protections we have now," Phillips told the meeting.

An unresolved issue is FDA's focus on the current GMPs, which "keep ratcheting up," and process validation, while "some foreign regimes think finished-product testing is the way to go."

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.