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FAQs on Debarments/Disqualifications

Questions and Answers on Debarments and Disqualifications

Q1: What is a “disqualification” or a “debarment,” and what is FDA’s authority to perform these actions?

A: The FDA has the authority to “disqualify,” or remove, researchers from conducting clinical testing of new drugs and devices, when the agency determines that the researcher has repeatedly or deliberately not followed the rules intended to protect study subjects and ensure data integrity. Further, the FDA can disqualify a clinical investigator who has repeatedly or deliberately submitted false information to the agency or study sponsor in a required report.

Under its statutory debarment authority, the agency may also ban, or “debar” from the drug industry individuals and companies convicted of certain felonies or misdemeanors related to drug products. Once individuals have been subjected to “debarment,” they may no longer work for anyone with an approved or pending drug product application at FDA. Debarred companies may no longer submit abbreviated drug applications.

Q:2 How frequently are clinical investigators disqualified or debarred? How many disqualifications or debarments have been done or are pending at any given time?

A: FDA began disqualifying clinical investigators in the early 1960’s. Since then, the agency has disqualified approximately 190 clinical investigators. From 2006 to present, FDA initiated 21 disqualification actions. Of these, 18 actions have been completed, and three are currently pending further action.

Since FDA received its debarment authority in 1992, FDA has debarred 75 individuals convicted of crimes related to drug products. Until this year, the agency has averaged two or three debarment proceedings per year over the past decade. Since October 2008, FDA has formally initiated debarment proceedings against five individuals and debarred two others. We have also begun internally processing nine additional debarment actions.

Q3: What are the timeframes for disqualification and debarments under the recently issued procedures, and how successful has FDA been in meeting them?

A: FDA finalized new procedures for disqualification actions in June 2008. Since 2008, the agency initiated ten disqualification actions, and of those, only the two initiated in 2009 are still pending. These timeframes are consistent with the targeted timeframes under the new disqualification procedures.

Over the past decade, FDA has typically taken three or four years from the date of conviction to debar individuals. The timeframes under the new procedures will usually result in debarment within a year of the individual’s or company’s conviction. The agency is still addressing a backlog of potential debarment actions, but the rate at which the agency has started and finished debarment actions since late last year is consistent with the other timeframes in the new debarment procedures.

Q4: How will the new procedures speed up disqualifications and debarments?

A: FDA’s new procedures are aimed at ensuring effective oversight, efficiency, and uniformity in the agency’s handling of disqualification and debarment matters. Making both processes more uniform throughout FDA and adding targeted time frames for the various steps in the process will facilitate timely resolution of disqualification and debarment actions. In addition, for the disqualification process, FDA has designated an administrative law judge to serve as a presiding officer and has assigned one office, the Good Clinical Practice Program, to oversee the disqualification process. For debarment proceedings, there will now be dedicated staff assigned to both starting and continuing debarment actions and a specific office will be charged with ruling on particular procedural matters.

Q5: Some disqualifications and debarments appear to have taken years. How can that be?

A: FDA’s disqualification and debarment processes strive to balance timeliness with honoring the rights of the individual to contest the allegations and argue against disqualification and debarment. Because of this, even under the revised procedures, both processes can be complex and time-consuming. Extensions may be requested by either FDA or the individual, or it may be necessary to collect additional information. In all cases, FDA works to ensure a fair process while also ensuring timely resolution.

Q6: Some House members concerned about these actions suggest that patients are put at unnecessary risk. What is the likelihood that a researcher in the process of being disqualified or debarred is actually carrying out clinical trials while FDA is going through their legal process?

A: The likelihood that a researcher is actually carrying out clinical trials while FDA is pursuing disqualification is very small. The chances that an individual subject to debarment is carrying out clinical trials are even lower. In the case of a pending debarment, the individual, if not in prison, has been convicted of crimes that make employment in the drug industry difficult. In the case of a pending disqualification, if the researcher is still involved in a clinical trial, FDA has the authority to put the clinical trial site on hold, or the agency may work with the study sponsor to arrange for another investigator to take over that particular site, thereby removing the researcher from the study.

Q7: FDA proposes to publicly disclose the names of those facing disqualification or debarment. Isn’t this some sort of violation of their privacy? Aren’t they deemed innocent until proven guilty?

A: FDA receives multiple requests for information about both pending and completed disqualification and debarment actions under the Freedom of Information Act (FOIA). Therefore, the agency posts on its website lists of investigators who have been disqualified or for whom such action has been initiated. FDA also posts similar information for debarment actions. This information is made public so that sponsors, among others, are alerted to the alleged misconduct. (See Q12 below for links to this important information.)

Q8: Is a sponsor testing a new drug or medical device at risk if they use one of these suspect clinical investigators? Can you explain what their vulnerability is?

A: If a clinical investigator is disqualified, FDA’s review staff evaluates the researcher’s data to determine if his/her data should be excluded from the study analysis. For example, if a researcher had multiple protocol violations and/or failed to report adverse events, the data generated at that study site may not be considered reliable and could therefore be excluded from consideration as part of the application. FDA would use a similar process for clinical studies conducted by debarred individuals. Therefore, for study sponsors, having data generated by a clinical investigator who is subject to disqualification or debarment could mean that this data would be called into question and possibly removed from the final analysis.
Q9: Some House members have requested a GAO study. What has GAO found and when will that report be released?

A: Some members of the House Energy and Commerce Committee have expressed concern over FDA's use of its debarment and disqualification authorities. They have asked the GAO to study this matter. GAO has not yet released a report.

Q10: What is the process FDA goes through for disqualifying or debarring someone?

A: For both disqualifications and debarments, the process begins with written notification to the individual that he or she may be subject to an administrative action. An individual then has an opportunity to explain the conduct at issue and/or challenge FDA’s basis for the administrative action.

If an individual disputes the facts the agency relies on for disqualification or debarment, there may be a hearing. If an individual disagrees with factual and legal findings made at lower levels of the agency, he or she may request review of the findings by the Office of the Commissioner and, ultimately, a federal court.

Q11: What exactly is the scope of FDA’s debarment authority with respect to drug products?

A: FDA has the authority to prohibit certain individuals and companies from participating in certain aspects of the drug industry. If an individual is convicted of certain felonies or misdemeanors, such as those related to the drug approval process or FDA’s regulation of drugs in general, FDA may debar that individual. Debarment means that the individual may no longer work for a firm holding a pending or approved drug product application at FDA. Moreover, FDA will not accept or review abbreviated drug applications submitted by debarred individuals. Companies are also subject to debarment for felonies and some misdemeanors if the offenses are related to the development or approval of an abbreviated drug product application, which related to generic drugs. A debarred company cannot submit, or assist others in submitting, future abbreviated drug product applications.

Q12: Where can I find more information about FDA’s debarments and disqualifications?

A: FDA maintains a public listing of disqualification actions at www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/ucm131681.htm. This listing includes both pending and completed disqualification actions based on the stage of the proceeding. Information regarding completed debarment actions can be found at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm. FDA is planning to expand the listing to include pending debarment actions in the near future.