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Dominant medical device issues for policymakers in the capital during 2007 included reform of FDA user fees, revived congressional oversight, and continuing turbulence over FDA compliance and enforcement.

It was also the first full year with a permanent commissioner at FDA since 2003, as Andrew von Eschenbach took charge and aimed to break the policy inertia that had settled over the agency. He repeatedly asserted a commitment to greater transparency, but progress was slow due to competing demands and scarce resources.

His public pronouncements on medical device issues were few, since unrelated controversies—such as contaminated imports and improper employee bonuses—seemed to engulf the agency. The problems were often propelled by the Bush administration’s foes on Capitol Hill.

Von Eschenbach’s only public utterances before a device audience were via satellite in March, when he addressed the AdvaMed annual meeting in Phoenix. His main focus then was the incubating reauthorization of user-fee legislation, which ultimately came to pass six months later when President Bush signed the FDA Amendments Act into law.

New User Fees

The new law set low, predictable user fees that increase the agency’s total take but reduce the fee for each individual application. It introduced a periodic report filing fee of $6475 and annual establishment fees of $1706. FDA predicts it will get 31% more in revenues while significantly reducing application fees. For example, a premarket approval (PMA) or biological license application will cost $185,000 each, which is a 34% reduction from the 2007 rate. A 510(k) will cost $3404, down 18%.

FDA accepted “aggressive performance goals” under the agreement. It promised to reach a decision on 50% of expedited PMA and supplement applications that go before an FDA advisory committee within 180 days, and to decide on 90% of the expedited applications within 280 days. FDA committed to reach a decision on 60% of conventional PMA and supplement applications that go before an advisory committee within 180 days, and 90% within 295 days. The agency also agreed to decide on 90% of 510(k) applications within 90 days, and 98% of the applications within 150 days.

Businesses with $100 million or less in annual sales or receipts had their fees reduced from 80% of the full fee in the first device user-fee program to 50% for 510(k) applications, and from 38% to 25% for PMA and related supplement fees.

The new law requires medical device companies to add their clinical trials to a public registry, as drug companies already do. It also incorporates the Pediatric Medical Device Safety and Improvement Act that requires device sponsors to include a description of pediatric populations in their product marketing applications to FDA.

A sleeper provision in the new law establishes the Reagan-Udall Foundation, a little-discussed private foundation within FDA. Its objectives include the “identification of unmet needs in the development, manufacture, and evaluation (including postmarket evaluation) of the safety and effectiveness of FDA-regulated products, and the establishment of scientific and other projects and programs to meet those needs.”

The foundation, which is to be directed by a 14-member board with four members drawn from regulated industry, quickly came under attack from liberal and consumer-oriented interests. For example, Center for Science in the Public Interest’s Merrill Goozner, declared that “the last thing you want is an industry-run board in which they create a science-sounding rationale before they put the FDA rubber stamp of approval on something that hasn’t been proven.” If industry gains too much influence on the foundation’s board, he said, the criteria that FDA establishes for evaluating products could be too industry-friendly for patients’ good.

Capitol Hill Oversight

The new Democratic majority on Capitol Hill lost no time in reviving FDA oversight, which had become all but moribund under the old Republican majority. One noteworthy exception was Senator Charles Grassley (R–IA), but he had garnered little support from his colleagues until the Democrats took over.

Numerous investigations of FDA were initiated, notably under John Dingell (D–MI), who was restored to chairmanship of the House Energy and Commerce Committee. Dingell and his subordinate Oversight and Investigations Subcommittee, chaired by Bart Stupak (D–MI), tackled several device issues. These included whether FDA had gone too easy on Johnson & Johnson’s Cordis Corp. in 2004, when the agency found serious adulteration issues with its Cypher stents.

The minority staff of the subcommittee, energized by a new bipartisanship, challenged the fairness of FDA’s legal tactics concerning TMJ Implants (Golden, CO). FDA came under fire for demanding civil monetary penalties from the small device firm before dealing with the company’s appeal to the FDA commissioner on its failure to file 17 medical device reports (MDRs). At press time, the subcommittee’s efforts had yielded little.

Most of the increased attention to FDA on Capitol Hill involved issues not specific to medical devices, although there was some overlap. One topic was the disclosure to Dingell’s committee, which is investigating allegedly improper bonuses paid to FDA managers, that three CDRH managers had received large bonuses in 2006. The CDRH officials are former CDRH deputy director Linda Kahan ($34,000), compliance director Tim Ulatowski ($21,000), and senior associate director Lillian Gill ($20,000).

– James G. Dickinson

 

FDA has taken several steps to improve its advisory committee process, including asking the question, “Is it possible to have advisory panels with no financial conflicts?” The agency has released a report that highlights the difficulty in finding qualified panel members who have no such conflicts. The report suggests that attempting to find experts with no conflicts would “represent an uncertain and potentially substantial additional burden on the cost and timeliness of advisory panel operations.” The bottom line is that no one is free from conflict.

FDA was interested in whether it is possible to assemble advisory committee meetings composed of highly qualified individuals, none of whom require a waiver for potential conflict of interest. FDA commissioned Eastern Research Group (ERG) Inc. of Lexington, MA, to conduct the study. The study had the following four objectives:

• Measure conflicts of interest for a sample of standing committee members and summarize financial conflicts.
• Measure overall expertise for a sample of standing members.
• Estimate the relationship between expertise and conflict of interest.
• Create hypothetical meeting rosters by identifying individuals who would not require a waiver but would match the overall expertise of a standing member.

The 55-page report, “Measuring Conflict of Interest and Expertise on FDA Advisory Committees,” found that other candidates might exist, but that many of these would also require the waivers granted to existing panel members. The report found that those with waivers tend to have higher levels of expertise than those without waivers.

According to the report, FDA is concerned that by excluding members who require waivers, the agency will lose the most qualified experts, and thus “diminish the quality of scientific advice regarding important public health decisions.”

The report notes that putting together a committee with no financial ties to industry would require starting with a much larger pool of candidates than FDA now uses. Additional screening would certainly take more time and could adversely affect not only the logistics of putting a panel together, but also the panel’s ultimate responsiveness. The additional time “could significantly delay committee meetings and related FDA actions on major public health issues,” the report says.

“We conclude that the ability to create a ­conflict-free panel is speculative, and that, even if possible, recruiting and screening costs would be much higher than current expenditures,” ERG says. “Furthermore, the additional time required to screen candidates could significantly delay FDA decisions on major public health issues.”

The report makes another important point: A conflict of interest is a condition—not a behavior—and does not imply that a person will act in a biased manner. Many in mainstream media are quick to believe that conflicts of interest on FDA panels lead to inherent biases on the part of panel members.

In addition to the report, FDA has issued two new draft guidances and has formalized its operating procedures. These steps will surely help it avoid the appearance of conflict of interest. The report, however, should make the doubters take notice. Conflicts are clearly inevitable. It is up to FDA to ensure that going forward the process is transparent and consistent.

– Sherrie Conroy

FDA is experiencing a serious challenge in the face of a wave of imported product recalls, especially those coming from China. “We have to get a handle on it,” said Gail Costello, acting director of FDA’s New England District Office. Costello, who spoke at MassMEDIC’s annual FDA Update event on Friday, implied that resources have been part of the issue when dealing with imported products. About 28% of FDA-regulated imports are medical devices and radiological health products. Product recalls, including those beyond medical devices, put a strain on FDA district offices. For example, there are normally about 5000 consumer compliants per year. During the pet recall last summer, FDA received 19,000 compliants in a three month period. More than half of the New England district staff had to work on the recall, thus pulling resources away from other areas. According to Costello, part of the government’s efforts to address the problem is to “prevent, intervene, and respond.” The Import Safety Plan consists of an interagency working group that is roadmapping an action plan to improve the safety of imported products. Costello says this plan is a major focus of FDA’s Office of Regulatory Affairs in both the short and long term.

– From MD&DI’s blog.

A subcommittee of the Science Board, an FDA advisory panel, issued a report that says what FDA observers have probably gathered for a while: that FDA lacks enough funds to perform its mission, and American lives are at risk as a result. The report says the agency suffers “serious scientific deficiencies,” reports Bloomberg News. It says the agency needs more money, better computer systems, and a restructuring at the top to include a scientific leader.

One place to start would be to move FDA’s appropriation out of the Agriculture group and into where the group that covers the rest of the Department of Health and Human Services. This archaic structure dates back to the earliest days of food and drug regulation, when HHS didn’t exist and the office that became FDA operated out of the Agriculture Department. But under the current system, the members of Congress who have oversight of the agency are not the ones who decide its appropriation. This results in a lot of saber-rattling about the agency’s deficiencies, but not a lot of action when it comes to budgeting to fix them.

– From MD&DI’s blog.