The US Food and Drug Administration has been sued by consumer advocacy group Public Citizen to force the agency to disclose more information about the people whose opinions help determine the fate of numerous drugs and devices. These individuals are on what is called the Center for Drug Evaluation and Research Advisory committee.The FDA uses these researchers and physicians to review marketing applications from companies reason their recommendations are generally followed.Ā However, panel members may be biased based on their relationship with a pharmaceutical company.
The resumes of the advisory scientists are publicly available because they are posted on the FDA web site prior to committee meetings. However, Public Citizen says that the FDA redacts information from most resumes submitted by advisory committee members.
In its lawsuit, Public Citizen contended that of the 150 resumes posted for members of Center for Drug Evaluation and Research advisory committees as of April 6, 2016, 138 had redactions, or 92 percent. The CDER is the division that decides approvals, provides suggestions about clinical trials to be conducted, and regulates product labeling for medicines.
In its lawsuit, the consumer group said that at one point, the FDA sent a letter saying its practice is to “categorically redact” certain information from resumes, including nongovernment funded grants; pending clinical trials; pending publications; dates degrees were conferred; medical board and professional association certification numbers; names of graduate or doctoral students supervised; military service; and information related to hobbies and outside activities.
Jeffrey Newman represents whistleblowers.
