HIMA, FDA Converge on Third-Party Reviews : Industry Respondents Say FDA Reviewers "Lack Expertise" : Center Plans High-Tech Exchanges : Consensus Standards: Normally, FDA Won't Look : New FDA Ombudsman Is Activist

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published May 2000

FDA was once opposed to outside reviews of product submissions. Now industry is scrambling to catch up with the agency's aggressive plans to support the concept.

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Astrange alliance developed in March between FDA and the Health Industry Manufacturers Association on an issue that has divided them for at least 15 years—paying for medical device approvals. Until the mid-1980s, FDA used to sit in appreciative silence as HIMA went to bat on Capitol Hill for bigger FDA device-approval appropriations. Then FDA got the idea that user fees were the way to go. About the same time, HIMA realized that even when its pleas for more agency funding were heeded, FDA didn't seem to approve new devices any faster. Next, a rival industry trade association, the Medical Device Manufacturers Association (MDMA), sprang up, specifically to oppose user fees. MDMA rallied behind the European alternative of third-party, or non-FDA, approvals.

FDA did not like the third-party idea. Nobody likes to lose turf, particularly not government bureaucrats. So FDA dug in with annual pleas to Congress for user fees. MDMA dug in with annual pleas for third-party approvals instead. HIMA wavered, one year backing user fees, then beating a hasty retreat to the other side in response to the outcry from its members. Nobody was getting anywhere with these standoffs until 1997, when MDMA won some ground with the provisions in the FDA Modernization Act (FDAMA) ordering FDA to cooperate with third-party reviews.

FDA had already started third-party reviews rather grudgingly on its own, and had anointed some reviewing organizations to do them. However, the only devices the agency offered for outside review were the simplest ones that it was already reviewing quickly and at no charge to sponsors.

Unsurprisingly, the third-party review program went nowhere. Even the booster of FDAMA seemed unable to lift it off the launch pad. FDA broadened the list of eligible devices, but few third-party reviews resulted.

Events in the background, however, would change everything. A Republican-controlled Congress, never a friend to FDA, had been tightening the purse strings year after year, and the agency was starting to starve. Turf began to matter less than survival. The bureaucrats were ready to get really, really serious about third-party review.

The agency's new fervor came out at HIMA's annual meeting in Phoenix in March. There, device center deputy director for science Elizabeth Jacobson announced that FDA foot-dragging on third-party review was over.

"We have decided that we intend to expand the program," she told HIMA. "In fact, we would like to expand the eligible list as far as the law allows. We will be working with the third parties on how to get them up to speed on all these new device types. We have to deal with how we do this where there is no guidance document. We'll do that, and we hope to have the extension document out for comment in April."

Pointedly, Jacobson added that "CDRH has put an incredible amount of investment into making this thing work. So far, we seem to be the only ones at the party." HIMA hastened to disabuse Jacobson of that idea. Its board met that very afternoon; the next day, the association issued a news release saying the board had voted to encourage the use of FDA's third-party review program and to commit larger firms to use it for at least two to three products each. The release described the board's action as "a sign of increasing cooperation between industry and FDA on implementation of the FDA Modernization Act." It said the HIMA board's resolution "also calls for creation of an industry/FDA group to work on expanding the existing third-party review program and educating manufacturers on how to use the program."

In her presentation, Jacobson said there were "incredible possibilities" for the third-party review program, which is already open to about 25% of all 510(k)s received—about 1200. But last year, only 32 applications came through third parties, she said. "For those 32, the average review time was 57 days, compared with 105 days for the other 1100 or so. Our final decisions matched the third parties' recommendations 100% of the time, and 90% of the time we got to that decision on the first cycle."

It's interesting to see how differently FDA's two main regulated industries, human drugs and medical devices, have come to the same cooperative posture toward the agency, each nudged by acts of Congress. In the case of drugs, legislation enabling user fees for internal FDA reviews brought the two sides together. In the case of devices, it's a combination of FDAMA's provision for external reviews and niggardly congressional appropriations that's forcing both sides into this novel partnership.

FDA's CDRH may have improved its relationship with industry, but respondents to a recent industry survey found fault with the technical expertise of FDA reviewers and their lack of clarity in making data requests. The biennial survey, Improving America's Health, was conducted jointly by the University of California at San Diego's Technology and Entrepreneurship Program and PricewaterhouseCoopers. Similar surveys were conducted in 1995 and 1997.

Respondents to the 1999 survey were U.S. companies that had a drug, device, or biologic in clinical trials under FDA supervision between January 1, 1998, and June 30, 1999. It was the first survey conducted since enactment of the FDA Modernization Act in November 1997.

The respondents indicated that there has been improvement in the overall communications between FDA and product sponsors, particularly in response time and ease of contact. Overall, 48% of the respondents characterized their communications with the agency as excellent, up from 41% in 1997 and 34% in 1995. In addition, 64% said they received a response to their inquiries in an average of five days, up from 45% in 1995 and 52% in 1997. And 64% said it was easy or very easy to contact the reviewer, up from 52% in 1995.

But those surveyed said that several factors, including turnover of FDA staff, continue to delay the approval process unnecessarily. An increasing number of companies (42%, versus 27% in 1997) indicated that a change of key reviewers impeded the approval process. In addition, 27% said that a lack of technical expertise on the part of a reviewer unduly delayed the approval process, up from 21% in 1997 and 18% in 1995. Some 30% of respondents in all three surveys pointed to a lack of clarity in FDA's requests for more data as a factor impeding the review process.

HIMA president Pamela Bailey said her members "applaud the agency's work to improve communications with sponsors, respond more quickly to their inquiries, and facilitate contacts between FDA reviewers and product sponsors." Although he had not been able to study this survey's results, CDRH director David Feigal questioned the representativeness of the opinions sampled, noting that a similar survey had only a 23% response rate covering only 2% of the industry. Feigal commented that CDRH is at a 10-year low in staffing, and "we will shrink some more" if this year's request for budget increases is turned down again. "As you probably know," he told this writer in an e-mail, "FDA has lost nearly 1000 non-PDUFA [drug user-fee] positions in the last eight years. [These] figures suggest that the effects are beginning to show."

CDRH promises more high-tech exchanges of information with its various constituencies as part of a performance plan unveiled on its Web site at the end of March. According to the FY 2001 performance plan, "FDA will be able to improve its ability to receive and distribute device-related scientific information into, around, and out of the organization in an efficient manner."

It says the center will encourage scientific exchange and the dissemination of information by using standardized computer systems, integrated technologies, and enhanced Web sites on the Internet. "These improvements will allow for greater information sharing between FDA and its stakeholders and among the FDA centers," the plan says. Other components of the performance plan on leveraging CDRH communications include

The performance plan also outlines many review and inspection goals for fiscal year 2000. The plan may be seen at http://www.fda.gov/ope/fy01plan/devices01.html.

FDA won't ordinarily expect manufacturers citing conformance with consensus standards to show proof of that conformance. So CDRH says in a new guidance document that outlines ways in which standards can be used by manufacturers in 510(k) submissions.

This reliance on sponsor declarations conforms with both the declaration section (514[c]) of the FDA Modernization Act and the act's "least burdensome" provisions in section 513(i)(l)(D), the guidance says. The document expands upon earlier guidance by discussing "the use of FDA-recognized standards in 510(k)s that do not contain a declaration of conformity, and the use of nonrecognized standards." The guidance, "Use of Standards in Substantial Equivalence Determinations," may be seen at http://www.fda.gov/cdrh/ode/guidance/1131.pdf.

CDRH has appointed its first ombudsman and quality assurance manager. "I intend to be an activist, problem-solving ombudsman," attorney Les Weinstein told attendees at the annual HIMA meeting in March. The center's existing dispute-resolution mechanism requires an official decision to have been made—something that won't be necessary in matters he deals with, Weinstein said. "I will have a lot of flexibility to solve problems at any stage.... As QA manager, I'll be looking at the quality and consistency of the decisions that the center makes." Weinstein holds degrees in law and public administration. He joined the Department of Health and Human Services in 1971, conducting studies of state Medicaid programs. He then moved to the Office of the Assistant Secretary for Health, supervising HMOs. He joined FDA in 1980, working with the regulations staff, international affairs, and the Freedom of Information Office, where he most recently was its denials and appeals officer.

CDRH deputy director for science Elizabeth Jacobson told HIMA the ombudsman's job as defined by CDRH director David Feigal involves "actively seeking out problems, visiting manufacturers, going to meetings. David does not see this as a sit-in-the-office, wait-for-problems-to-come-in-the-door type of position. He really wants the ombudsman to get out there and talk to people, to find out what's going on."

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

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