WASHINGTON WRAP-UP

When a medical device manufacturer appeals an adverse CDRH decision to FDA, that move won't stop the center from escalating the matter to a civil money penalty action before the appeal is considered. Indeed, it won't even guarantee that the appeal will be heard.

Such a bizarre scenario has actually taken place, and it came to a head in April. House Energy and Commerce Committee ranking minority member Joe Barton (R–TX) and colleague John Shimkus (R–IL) intervened in the nine-year battle between CDRH and the small Golden, CO–based manufacturer of temporomandibular joint prostheses, TMJ Implants Inc. (TMJI).

CDRH director Daniel Schultz told TMJI that it could use 21 CFR 10.75 to appeal his decision that CDRH was correct to demand medical device reports (MDRs) from the company on 17 contested postimplant events. But why did he tell that to the firm when, eight months later, that appeal was rejected without consideration just three days after the civil money penalties case was launched?

This action, the two lawmakers wrote FDA commissioner Andrew von Eschenbach, amounted to a practice of FDA using “the intervening time before responding to the appeal request to prepare the enforcement action. We do not believe there is ever a situation where FDA should be given a license to lie to regulated industry.”

This saga has been running so long that many of its observers, including pertinent FDA officials and their congressional overseers, no longer remember how it began. In 1999, an opinionated senior reviewer tried to remove the company from the temporomandibular joint (TMJ) prosthesis market and was eventually overruled by now-deceased Office of Device Evaluation director Bernard Statland, leaving resentments that the company's defenders call a “vendetta.”

In March, the Departmental Appeals Board of FDA's parent, HHS, upheld $340,000 of the $510,000 in civil money penalties levied last year against TMJI by FDA administrative law judge Daniel Davidson.

The board said Davidson had erred in assessing civil money penalties ($10,000 per unfiled MDR per defendant) against TMJI's regulatory manager, Maureen Mooney, but had not erred in the penalties assessed against the company itself and its president, Robert Christensen.

Christensen immediately vowed to appeal in federal court, even as both Barton and Shimkus vowed to publicly question von Eschenbach at an April 22 budget hearing on how his agency has behaved in the matter.

Apart from a February letter to Barton from FDA acting assistant commissioner for legislation Stephen Mason, FDA management has not addressed any of the company's complaints with third parties.

Mason's letter said the agency's “regrettable” mislaying of TMJI's appeal for eight months had not prejudiced the company's rights in any way. He stoutly defended launching the civil money penalties action instead of hearing the appeal. If appeals stayed enforcement actions, he said, companies “could use the 10.75 process to shield themselves from enforcement actions or potential adverse judgments.”

Barton and Shimkus faulted this reasoning in their response, saying it reflected a policy of allowing regulatory disputes to escalate because of a lack of early top-management intervention. The congressmen also said it showed a failure to engage in good-faith dispute resolution.

Interestingly, the Departmental Appeals Board's decision suggested that there are two pertinent standards that are irreconcilable.

In its 64-page final decision on Davidson's ruling, the three-member board said one of these standards was the medical judgment or clinical standard asserted by Christensen, and the other was the legal or regulatory standard asserted by FDA. The latter was upheld by both Davidson and the board as the supreme and controlling standard.

So the saga continues between two adversaries who seem destined to tell their stories in federal court.

FDA Urged to Regulate All Lab Tests

FDA should have some level of oversight for all laboratory tests, including the more than 1100 genetic tests now offered by hundreds of laboratories across the nation, according to an HHS advisory committee report.

The committee voted recently that the gap in oversight of the clinical validity of these tests should be closed as quickly as possible. The final report from the Secretary's Advisory Committee on Genetics, Health, and Society was written in response to a charge from HHS secretary Michael Leavitt to examine the need for genetic testing oversight. It calls for a number of actions in various HHS agencies to beef up information-gathering and regulation of the tests.

The recommended FDA oversight is a huge undertaking, committee members recognized, and it will require “commitment of significant resources” to avoid harming patients and to avoid stifling technological innovations. According to the committee's draft report, FDA has cleared or approved fewer than 100 genetic tests so far.

A key issue in committee discussions was whether there should be a difference in regulatory oversight for in vitro diagnostics (IVDs), which are developed by manufacturers for distribution to numerous labs after FDA clearance or approval, and oversight for laboratory-developed tests (LDTs), which are developed for use solely in the developer's laboratory. The report notes that only recently has FDA exercised regulatory authority over LDTs.

For the most part, LDT regulation has been left to regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the report says. Overseen by the Centers for Medicare and Medicaid Services (CMS), CLIA requires all clinical laboratories to be inspected for standards compliance. The secretary's committee says that is not enough, although some committee members did voice concern that it would slow innovation if laboratories were to go through the same level of FDA regulation as IVDs. The committee decided that from a patient's viewpoint, the question of whether a test is an LDT or IVD is not a priority.

Steven Gutman, CDRH's director of IVD device evaluation and safety and also an ex officio committee member, said that patients simply want a test to work. They also want someone other than the sponsor to be responsible for saying that it works.

The committee discussed how to prioritize tests for oversight according to the risks they pose to patients—especially in light of the huge number of LDTs, many of which may be exotic and rare, according to Gutman. The panel finally recommended that HHS convene a multistakeholder group from the public and private sectors to determine the criteria for risk certification of tests. The group would also be tasked with developing a process for systematically applying such criteria.

In another major recommendation, the committee indicated that a yet-to-be-determined federal agency should create a mandatory, Web-based database of all tests. The committee discussed whether such a database should be at the Centers for Disease Control and Prevention, CMS, or FDA. However, in light of the practical and legal questions, the committee said HHS should appoint and fund a lead agency to develop the database, maintain it, and to work closely with its sister agencies on it.

FDA should engage other agencies and prepare a guidance document on its authority to regulate clinical support systems, the committee said. The guidance should “explain in particular which features of the system constitute a device” as the term is used under FDA authority.

Other Committee Recommendations

The recommendations also said that FDA, among other federal agencies, should strengthen its monitoring and enforcement efforts against labs and companies that make false and misleading claims about genetic tests.

In addition, the committee stated its concern about certain types of genetic tests that are marketed directly to consumers, especially about the insufficient oversight of the labs offering them. The committee said that CLIA's authority, along with FDA's risk-based regulatory authority and processes, should be expanded to encompass the full range of health-related genetic tests.

It also noted that although “FDA has asserted its authority over clinical decisions support systems, the extent to which the agency intends to regulate such systems is not clear. Given that [such] systems will be necessary to communicate information appropriately in the pre- and postanalytic period, and because these systems contain elements that involve the practice of medicine, clarification of the nature and scope of FDA oversight of such support systems is critical.”

Schultz: No Policy of Seeking More 510(k) Data

There has been no policy decision made at CDRH that would require more data to accompany 510(k) submissions, center director Daniel Schultz told a questioner at an FDLI annual meeting session in March.

“We need better data for more-complex 510(k) products,” he said. “We can't review very complex products, often with numerous software changes, in the same way as we would products with only two moving parts.” He said that CDRH will continue to take a risk-based approach to data requirements, asking for all necessary data to conduct adequate reviews.

Earlier, in a presentation on CDRH activities, Schultz said the center is now able to track every medical device postmarket study that has been required of sponsors, that is currently under way, or that has been completed. This was not the case in the past.

Moreover, Schultz said, CDRH has improved its postmarket monitoring ability with the creation of a surveillance matrix, or “network system.” It is designed around several device categories, including cardiac, orthopedic, and ophthalmic devices; radiological products; and neurology, anesthesia, and respiratory equipment.

Improvements have also been made to the MedSun surveillance system, Schultz said, enhancing CDRH's ability to gather and interpret information on adverse events associated with the use of medical devices. He indicated that adverse-event reports from hospital labs and other MedSun reporting sites are often received electronically, which has improved the center's ability to spot postmarket problems quickly and to analyze trends in device use.

Schultz also said that CDRH has started developing a unique-device identification system regulation, which will assist in identifying and, if necessary, recalling problematic devices, as mandated by the FDA Amendments Act of 2007.

Schultz said modernization of CDRH's information technology (IT) capabilities is well under way. He explained that the center is able to use a common FDA electronic portal, or gateway, for receiving adverse-event reports, with incoming reports automatically directed to the appropriate FDA centers for action or review. How important is robust IT? Just consider the volume of work flowing through the center. It receives more than 9000 premarket submissions each year, comprising more than 3 million pages. There are now 40 million pages residing in the center's computerized IMAGE system.

GHTF Releases Regulatory Audit Guidelines

FDA says that the Global Harmonization Task Force's Study Group 4 has released a document titled Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers—Part 3: Regulatory Audit Reports. It provides a structure for audit reports used in multiple jurisdictions, promotes consistency and uniformity, and assists auditors in preparing reports for use by multiple regulators or auditing organizations.

FDA says that having reports that are consistent in content should facilitate the review and exchange of audit reports. In addition, acceptance of audit reports by multiple evaluators should eventually reduce the number of audits for manufacturers.

The agency is making the document available so that industry and the public may express their opinions. View the document at www.fda.gov/OHRMS/DOCKETS/98fr/E8-5927.htm.

LASIK Task Force Formed

FDA has partnered with the American Society of Cataract and Refractive Surgery (ASCRS), the National Eye Institute, and the American Academy of Ophthalmology to form a LASIK task force. The panel will study LASIK vision correction and its effect on the quality of patients' daily lives.

“Quality of life refers to a patient's ability to perform the activities of daily living, everything from driving, daily routine, family life, career and sports performance, to personal appearance, after LASIK,” according to an ASCRS release announcing the task force.

The group estimates that between 1998 and 2006, FDA received about 140 comments relating to LASIK dissatisfaction, which represents less than one out of every 10,000 U.S. LASIK patients. “What we are looking to do is study people who are satisfied with their procedure versus people who aren't—even though this is a rare occasional patient,” said ASCRS task force cochair Kerry Solomon.

The Ophthalmic Device Panel within FDA's Medical Devices Advisory Committee was expected to discuss postmarket experience with both phakic intraocular lenses and LASIK at its regularly scheduled meeting in late April.

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