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FDA loses authority to investigate its workers’ alleged criminal acts
Growing public concerns about the validity of FDA’s role in a longstanding joint investigative relationship with the OIG prompted the action.
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On Nov. 30, the Office of Inspector General at the Department of Health and Human Services terminated an agreement that allowed the U.S. Food and Drug Administration to jointly investigate alleged criminal acts by FDA employees. By April, the FDA is expected to transfer all of its remaining cases to the OIG. This action should strengthen physicians’ confidence in the scientific process that they rely upon in delivering care to their patients.
FDA’s joint investigative role
The OIG’s action ended a process that existed for almost 10 years. In 1998, the FDA negotiated a memorandum of understanding with the OIG that established shared responsibility among the agencies for investigating any potential criminal wrongdoing by FDA employees. Before the memorandum of understanding existed, the FDA’s Office of Internal Affairs (OIA), established in 1995, addressed allegations of FDA employee misconduct.
 Alan E. Reider |  Allison Weber Shuren |
This joint investigative relationship was unparalleled. The FDA is the only entity within HHS that has ever been granted such authority. The OIG has investigated HHS employee conduct without the aid of any particular HHS agency, other than the FDA, because it has statutory independence, which allows it to handle sensitive investigations that could involve employees at all levels.
Under the memorandum of understanding, the FDA has an affirmative requirement to report nonfrivolous allegations of “criminal offenses,” which include conflicts of interest, to the OIG. In contrast, allegations involving improper conduct that does not involve criminal activity may be reported to OIG or investigated by the investigative division of the FDA.
OIG’s frustration
Likely, the most pressing reason for ending the memorandum of understanding came from the growing public sentiment that the FDA faces significant conflict-of-interest issues. Physicians, scientists and FDA employees have been among the most vocal in voicing their concerns that close relations with the pharmaceutical industry have led the FDA to suppress less than positive drug safety information. One of the best examples directly inciting physician skepticism is the 2-year lag that occurred before label changes were made to Vioxx (rofecoxib, Merck), even though the FDA, while negotiating label changes, was aware of findings in a Merck study that heart attacks were five times higher for Vioxx patients than for patients on another drug. During this time, physicians and their patients were unaware of the cardiovascular risks. When the risks came to light, physicians were concerned that their regulators became facilitators for the drug industry.
In 2007, the OIG received inquiries from Congress and saw reports in the press that employees at the FDA were not following proper administrative procedures, which required them to refer potential criminal violations to the OIG, but rather were handling them internally. As reported in an April memo, specific cases brought to the OIG’s attention included potential criminal conflict-of-interest violations.
In a Sept. 6 memo, Inspector General Daniel Levinson notified FDA Commissioner Andrew von Eschenbach, MD, that the OIG was nullifying the memorandum of understanding for several reasons. Some of the difficulties that the OIG mentioned have existed since the beginning of the memorandum of understanding.
Mr. Levinson mentioned in the memo that “increased congressional and media scrutiny regarding allegations of potential criminal violations of federal conflict-of-interest statutes and regulations involving FDA and other officials in the department has resulted in OIG’s devoting increased attention and resources to ethics issues. As a result, OIG investigators and attorneys have developed significant expertise in handling these complex cases.”
In addition to the OIG’s investigative experiences of late, Mr. Levinson also claimed that the OIG’s independence makes it uniquely qualified to handle sensitive investigations of allegations of potential criminal misconduct within HHS. He highlighted the OIG’s Special Investigations Unit’s ability to “independently investigate allegations concerning senior level FDA officials and thereby eliminate any conflict of interest – in fact or appearance – created when FDA [OIA] agents are asked to investigate allegations of misconduct against a supervisory official.”
Mr. Levinson said no other agency had shared investigative authority with the OIG, and that there should be consistency in the manner in which the OIG investigates all HHS employees. To achieve uniformity, Mr. Levinson said primary investigative authority in such situations should now rest with the OIG.
Without providing any particular examples, Mr. Levinson also said under the memorandum of understanding there has been a lack of consistency in applying the terms.
FDA’s response
In his response to the OIG’s memo, Dr. von Eschenbach defended the FDA’s handling of investigations and countered that the OIG had taken on few of the cases referred to it by the FDA.
Dr. von Eschenbach countered the OIG memo by stating that the FDA/OIA had achieved its goals and had “pursued nearly 1,000 criminal and administrative investigations covering a broad spectrum of alleged wrongdoing by FDA employees including, for example, theft, forgery of documents, misuse of government vehicles and computers, sexual harassment, and outright threats or problematic behavior that could result in potential workplace violence issues.”
In contrast, Dr. von Eschenbach said the OIG had chosen to participate in, or lead, the investigation in a few instances. Specifically, he stated that out of the 265 investigations opened by the FDA/OIA since 2004, the OIG had chosen to handle only 15. He also made specific mention of two conflict-of-interest referrals that the OIG had declined to accept, despite FDA’s persistent efforts to refer them. However, he did not refer to any other conflict-of-interest issues.
Congress’ reaction
Sen. Chuck Grassley, R-Iowa, ranking member of the Senate Finance Committee, praised the OIG for restoring independence to such investigations. As the key member of the Senate involved in FDA oversight, Sen. Grassley has become increasingly skeptical over the past 4 years about the FDA’s ability to investigate its own employees neutrally. In a press release issued Nov. 29, Sen. Grassley said “cutting the tie is good for the public. It strengthens the role of the Inspector General. And in our system, the Inspectors General are vitally important independent watchdogs within the federal bureaucracy.”
Culture of confidence
Regardless of the scope of the FDA’s conflict-of-interest issues, relocating primary investigative authority for internal criminal investigations back with the OIG should help to rebuild the FDA’s public image. The regulatory process for approving drugs will likely be more transparent. Knowing that without the memorandum of understanding, the FDA will be more accountable to the OIG, HHS’ independent watchdog, and to the public regarding its drug safety decisions should help physicians be fully informed as they strive to treat their patients with the best care possible.
For more information:
- Alana Wexler, JD, can be reached at Arent Fox LLP, 1050 Connecticut Ave., NW, Washington DC 20036-5339; 202-828-3463; fax: 202-857-6395; e-mail: wexler.alana@arentfox.com.
Reference:
- Copies of documents concerning the memorandum of understanding between the FDA and OIG are posted with Sen. Grassley’s press release at: http://finance.senate.gov.