Medical Device Daily Washington Editor

WASHINGTON – As promised, the FDA published the steps it will take to reduce the potential for conflicts of interest in advisory committee meetings for product reviews. At a July 24 meeting of the Center for Science in the Public Interest (CSPI; Washington), Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs, enumerated the new guidance that the agency hopes will quell public concerns that dangerous products are making it to the market through the influence of committee members with commercial ties to the applicants seeking approvals.

The guidance addresses both the transparency in the committee selection process and the way in which waivers are granted to committee members with potential conflicts of interest. The agency stated that it is “taking these steps to make sure that it continues to have rigorous approaches in place that enable it to continue to recruit advisory members through a process that places the quality of scientific input sought by the agency as a top criterion.”

Gottlieb insisted that the advisory committee process “is integral to examining the intersection between medical practice and clinical research, to spark debate about it and to subject scientific work to close public scrutiny.”

“Some of the most valuable input often comes from people who are active practitioners but also heavily engaged in clinical research and we need to make sure that we continue to have the ability to recruit top clinical trialists,” he said.

In the coming months, the agency will put in place procedures intended to clarify the rationale behind the issuance of waivers as well as whether to disclose the reason for the waivers. The guidance will also address the release of briefing materials for product review hearings. More widespread “public dissemination of advisory committee schedules through increased mailings to public groups” is also on the guidance agenda though these meetings are routinely listed in the agency's web site.

The agency's Center for Drugs will undertake a “comprehensive look at current advisory committee practices [that] will include, among other things, the processes for choosing members with expertise specific to the meeting topic” as well as the development of the meeting agenda, according to Gottlieb's statement.

Much of the criticism of the advisory committee process has arisen since the publication of an article appearing recently in the Journal of the American Medical Association by a team led by Peter Lurie, MD, director of the health research group at Public Citizen (Washington). The agency posted a response to Lurie's criticisms, including that the FDA's analysis of Lurie's data showed that “advisory committee members and voting consultants with financial ties to pharmaceutical companies tend to vote against the financial interests of those companies.” The agency said this suggests that “fears that disclosed conflicts of interest are leading to tainted, unreliable recommendations are unfounded.”

The agency bases its assertion on the fact that many panel members who obtained waivers have relationships not with the sponsor in question, but with competitor companies. According to the FDA, Lurie's interpretation of tainted votes “only holds for the sponsoring companies; for competitors, yes votes on the index drug opposes their interests and no votes favor their interests.”

The document also argues that the Monte Carlo statistical simulation outcome “is consistent with the relative risk; the predicted average of 8.2 votes . . . for the financial interest of the company exceeds the actual average of 6 favorable votes.” The participation of voters with reported financial ties apparently reduces the votes for the product being considered.

Many of the agency's critics agree that an outright ban on committee members with such ties is unnecessary. Lurie would favor allowing scientists to sit on advisory committees so long as the dollar value of their stock holdings does not exceed $25,000.

During the CSPI session, Steven Nissen, MD, director of the cardiac coordinating center at the Cleveland Clinic (Cleveland), also an FDA advisor, said that the agency faces “a crisis in public confidence after a series of revelations about drug and device safety unprecedented in the history of this previously respected agency.” And he pointed out that the budget for the Center for Drugs is “only about $500 million and relies extensively on user fees.” Consequently, he argued, “the FDA is financially indebted to the companies it must regulate. This is a fundamental conflict of interest.”

OIG: Medicare imaging abused by providers

Daniel Levinson, the inspector general at the Department of Health & Human Services (HHS) informed the Center for Medicare & Medicaid Services (CMS; Baltimore) this past June 30 that an HHS audit of claims filed by independent diagnostic testing facilities (IDTFs) for calendar year 2001 disclosed “a marked pattern of repetitive use of services.” Levinson said the analysis suggested that IDTFs “enrolled with 10 selected carriers received $71.5 million in Medicare payments . . . for services that did not comply with federal law, regulations and guidelines.”

Levinson's memo to CMS administrator Mark McClellan stated that providers for 80 of the 230 beneficiaries whose records were reviewed “received 1,231 services that did not comply” with regulations and that the 94 IDTFs involved took in nearly $165,000 for those services. These numbers were apparently extrapolated to the entire Medicare program to arrive at the figure of $71.5 million cited above.

The violations cited by Levinson's office include failure to “always comply with initial enrollment application and subsequent update requirements” and failure to report “operational changes such as the identity and number of technicians, supervising and interpreting physicians, type and model number of equipment, and tests performed.” Changes of location and ownership also made the list of violations uncovered in the audit.

A pie chart in the report disclosed that of the $165,000 cited in the audits, more than $75,000 were for 546 services deemed not reasonable or unnecessary. Insufficient documentation plagued 544 services which came to almost $70,000, and 102 services were performed but not ordered to the tune of more than $12,000.

The Office of Inspector General (OIG) recommended that CMS go after the identified overpayments and perform further audits to recover additional monies. Levinson's memo also recommended that CMS “consider performing site visits to monitor compliance.”

According to Levinson, CMS agreed to pursue the overpayments provided that doing so would not cost more than the amounts that would be recovered. However, CMS apparently will not perform site visits due to budgetary considerations.