Product Safety, User Fees Top Issues in 2006

From enforcement actions to product seizures to holds on FDA’s acting commissioner’s confirmation, the past year has seen a focus on product safety and patient welfare.

James G. Dickinson

December 1, 2006

10 Min Read
Product Safety, User Fees Top Issues in 2006


Product safety and user-fee issues dominated Washington news for medical devices in 2006. Meanwhile, the search for a commissioner for FDA got bogged down in politics.

Other high-profile issues included major—and some controversial—enforcement actions against companies. The year also witnessed moves to require unique device identifiers (UDIs) and efforts by FDA to modify its culture.

User Fees

Of broad interest to manufacturers was the growing sense of malaise in the user-fee program. Both major industry trade associations, AdvaMed and the Medical Device Manufacturers Association (MDMA), supported some degree of restoration of congressional funding for FDA's product review activities, in lieu of increasing user fees. Industry uneasiness about this issue extends beyond medical devices. It prompted the launch of the FDA Alliance and the Coalition for a Stronger FDA. Both are broadly based lobbying efforts to boost congressional appropriations for the agency.

And, to top it off, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) must still be dealt with. If MDUFMA is not renewed by September 2007, the program will expire.

Even FDA itself is worried about its growing dependency on soaring user fees. It faces the very real prospect that industry resistance could pull the plug on essential agency resources. This September, the agency told Congress it would have to fire 264 employees if user fees were not reauthorized.

In April, FDA funded a study of industry opinion by the Lewin Group. Nearly 70% of the respondents said that MDUFMA performance goals have not resulted in meaningful improvements in review timeliness or predictability.

Lewin reported that many companies believe review times have remained “about the same” compared with pre-MDUFMA experiences. This may be owing to agency staffing and other operational constraints. As a result, respondents felt that MDUFMA had not translated into an improved return on investment of their user fees.

Bloomberg News reported in September that a key concern for device companies is that Congress will leave FDA funding levels unchanged. That would put more pressure on companies to make up for the funding with user fees.

Product Safety and FDA Culture

Product safety was at the heart of two CDRH internal culture initiatives in 2006. CDRH director Daniel Schultz announced both the culture of safety and the culture of collaboration in January. Both initiatives focused on internal reforms and external outreach through a series of public workshops. Three workshops were held, hosted by outside organizations with CDRH participation.

At the outset, industry representatives urged FDA to reconsider the term recall. They said it could be viewed as misleading when devices are modified or repaired and not necessarily removed from the market. They suggested FDA move to the term field corrective action instead of a recall in such situations.

In April, the Heart Rhythm Society joined this call via a set of recommendations. FDA accepted the recommendations in September, but not with respect to the retirement of the word recall.

FDA's Commissioner Search

Von Eschenbach's confirmation has been delayed, much to industry's dismay.

As the year drew to a close, the uncertainty of FDA's leadership dragged on. Acting commissioner Andrew von Eschenbach's confirmation is hostage to new holds placed on it by two senators. Earlier holds were lifted when he approved the morning-after emergency contraceptive Plan B for limited over-the-counter sale.

In June, von Eschenbach impressed medical device industry executives when he spoke at the MDMA annual meeting. He said that under his leadership, FDA “is committed to being strategically placed between discovery and development. We're not here just to regulate, but also to facilitate. The entire process from discovery to product development must become more integrative, more collaborative.”

In September, AdvaMed formally urged the U.S. Senate to confirm von Eschenbach, calling him “outstanding.” As a former director of the National Cancer Institute “and as a urologic surgeon and oncologist,” the association said, “he has a clear understanding of the value that medical technology brings not only to patient care but to the U.S. healthcare system as a whole.”

Guidant and Boston Scientific

Although FDA was impressed by Guidant's actions to address product safety during 2006, the firm was again embarrassed by a recall affecting its products, including the Ventak Prizm 2 ICDs.

FDA certainly considered product safety and the Heart Rhythm Society's recommendations during its long-running compliance issue with Guidant Corp. during 2006 as it was merging with Boston Scientific. In the end, the company agreed to incorporate the society's recommendations into an improved postmarket surveillance program. The company endured a sequence of CGMP violations and recalls affecting its implantable cardioverter-defibrillators (ICDs) and pacemakers.

In an innovative response that seemed to impress FDA, Guidant set up an independent panel of experts to review its handling of heart device adverse events. In March, the 11-member panel reported that the company needed to improve its communications with patients and physicians about device problems.

For its part, Boston Scientific began the year under an FDA cloud. It received an FDA warning letter complaining that corrections it had promised on GMP and quality system regulation (QSR) deficiencies were inadequate. The letter called them “spot fixes” and said the firm failed to comprehensively address violations at three facilities.

Possibly propelled by merger considerations, the company hastened to a lengthy meeting with CDRH director Daniel Schultz and top compliance officials in February. After the meeting, the agency said Boston Scientific had “acknowledged FDA's assessment of corporatewide quality system and device reporting deficiencies.” Boston Scientific vowed to work closely with the agency to resolve its issues.

In April, the firm also promised to implement all manufacturer recommendations in the Heart Rhythm Society's report on surveillance, analysis, and reporting of pacemakers and ICDs.

Two months later, the company was again embarrassed by a new set of recalls. The recalls affected its Insignia and Nexus pacemakers and Contak Renewal TR/TR2 cardiac resynchronization pacemakers. Also affected were its Ventak Prizm 2 and Vitality and Vitality 2 ICDs. The firm attributed the problems to a supplier's low-voltage capacitors not performing to specifications.

FDA later endorsed a recommendation by Boston Scientific and Guidant for physicians to conduct follow-up exams on patients implanted with the affected devices. The agency also endorsed the companies' decision to retrieve unimplanted devices for analysis.

Utah Medical

Safety had nothing to do with FDA's doomed GMP/QSR assault on Utah Medical Products Inc. In 2006, the firm continued to wrestle with the agency in equally doomed efforts to get compensation.

In February, FDA's parent, HHS, formally denied an administrative claim by Utah Medical for tortious abuse of process by FDA employees. However, the company pressed ahead with a request for reconsideration and a partially successful demand for corrections to FDA statements about it on the agency's Web site.

The agency grudgingly agreed to add Utah Medical's court victory over FDA to the documents posted. However, it refused to delete other documents the company said were rendered erroneous and misleading by the judge's decision against FDA.

In September, Utah Medical protested a denial by FDA associate commissioner for regulatory affairs Margaret Glavin. She denied the firm's documented claim that the agency had lied about conducting an investigation into its complaints. Contrary to her statement that “We consider this matter closed,” Utah Medical's CEO Kevin Cornwell responded: “It cannot come to closure until the truth is acknowledged.”

TMJ Implants

An alleged six-year CDRH campaign against Golden, CO–based medical device maker TMJ Implants Inc. (TMJI) was expected to come to a head at the end of November. The company was scheduled to go before FDA administrative law judge Daniel Davidson to contest FDA civil monetary penalties totaling $630,000 for refusing to file 17 MDRs. TMJI says the underlying events at issue—which occurred between October 2002 and July 2003—are not reportable. It claims that its qualified experts determined the devices did not cause the events.

CDRH argued to the contrary in briefs filed with Davidson. “Consistent filing of MDRs, even where there is no definitive proof of causation, demonstrates to FDA, consumers, and the public that a manufacturer takes its regulatory obligations seriously,” it said. Furthermore, CDRH said, “it shows that firms place a high premium on the health and safety of patients who rely on their products to support or maintain their health.”

TMJI says it was “ambushed” by CDRH director Daniel Schultz when he advised it to file an appeal with Lester Crawford, then-acting commissioner. Crawford sat on the appeal for eight months while the civil monetary penalties case was prepared against the company. The appeal was rejected only after the civil case was issued, TMJI says. If TMJI had known that penalties were being considered, it says, it would never have appealed. Rather, it would have filed the contested MDRs under protest instead.

Baxter Healthcare

In June, FDA and Baxter Healthcare Corp. signed a penalty-free consent decree aimed at resolving GMP issues involving the company's Colleague and Syndeo infusion pumps. With this decree, FDA departed from its common practice of seeking a disgorgement of profits provision. Instead, it allowed the company to post a $20 million letter of credit, which will be canceled once Baxter reconditions or destroys previously seized devices. The company paid $70 million for remediation costs associated with the decree.

The settlement followed an October 2005 federal seizure of more than 4000 pumps. The seizure was prompted by inspections that revealed the company had not followed device manufacturing requirements, despite several warning letters.


In October, FDA announced that it had sought a permanent injunction against a Florida device maker that had been marketing an unapproved device since 2002. The agency filed in Central Florida District Court against Orlando-based Endotec Inc. The filing named Endotec president Michael Pappas, medical director Frederick Buechel, and former regulatory affairs director Jared Pappas. FDA is seeking to stop the firm's “illegal distribution of unapproved total joint replacement devices,” an agency release said.

Previously, a March 2002 FDA warning letter cited Endotec for distributing the devices while it was awaiting FDA approval. The firm had corresponded with CDRH's Office of Device Evaluation and contended that distribution was legal. The firm claimed that the devices were custom and therefore exempt from the requirements of premarket notification. FDA said at the time that Endotec's position represented a fundamental misunderstanding of the custom device provisions of the Federal Food, Drug, and Cosmetic Act.


The long-running saga of an Illinois medical device company pursued by FDA for selling faulty, unapproved sterilization equipment to hospitals came to an end in September. Chicago federal judge Ruben Castillo sentenced Ross Caputo, president and CEO of now-defunct Abtox Medical, to 10 years in federal prison. His vice president, Robert Riley, received a six-year sentence. Their devices were reported to have caused 18 people to lose sight in one eye.

They had been indicted on mail and wire fraud charges arising from their sale of sterilizers that deposited toxic copper and zinc salts on devices. Abtox sold 168 sterilizers to hospitals around the country from 1994 to 1998 for approximately $18 million.

Unique Device Identifiers

In August, CDRH officials ended their gestation of proposals made in October 2005 that they get behind a bar code–type unique device identification (UDI) system. However, the center also announced a new gestation period for the idea, starting with a Federal Register call for public comments.

The four-page notice said CDRH believes UDIs could reduce medical errors, improve adverse-event reporting, and facilitate device recalls. The stakeholders meeting held 10 months earlier by FDLI urged FDA to make UDIs mandatory. “The transmission and translation of critical data has vast potential for improving patient safety and supply-chain efficiency,” a communication from the meeting said. “A compelling patient safety interest lies in requiring identification technology for certain medical devices, including implantable items like hip and knee prosthetics, stents, and cardiac rhythm management pacers.”

From public comments, FDA said it expected information on such a system's feasibility, utility, and benefits, and the costs associated with developing and implementing it. In addition, the agency wants to learn about various automatic ID technologies (e.g., bar coding and radio frequency) that could be used with a UDI system.

Copyright ©2006 Medical Device & Diagnostic Industry

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