In a bid to learn more about the experts who advise the US Food and Drug Administration, a consumer advocacy group has gone to court to force the agency to disclose more information about the people whose opinions help determine the fate of numerous drugs and devices.
At issue is an agency practice to redact portions of the resumes submitted by the scientific and medical experts who serve on FDA advisory committees, according to a lawsuit filed on Wednesday by Public Citizen in a federal court in Washington. The consumer group charged the redactions are “unlawful.”
The FDA taps these individuals to review marketing applications from companies, and for this reason their recommendations can hold great sway. Although the agency is not legally obligated to follow committee advice, FDA officials typically do so.
However, there are periodic concerns that one or more panel member may hold a bias reflecting a potential conflict of interest, even though the FDA several years ago stiffened conflict of interest rules for prospective panelists.
The resumes are publicly available because they are posted on the FDA web site prior to committee meetings. But Public Citizen charged that the FDA often makes it difficult to learn about possible bias or conflict because the agency redacts information from most resumes submitted by advisory committee members, according to its lawsuit.
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“Confidential information does not appear on documents crafted for the express purpose of sharing with other people,” stated Rachel Clattenburg, a Public Citizen attorney. “The redactions are unjustified and show that the FDA has wasted considerable time going through (resumes) to black out information. We worry that the FDA’s treatment of advisory committee member (resumes) is an indication that the agency favors secrecy over disclosure.”
An FDA spokeswoman declined to comment, citing pending litigation.
The consumer group filed the lawsuit after encountering difficulties with Freedom of Information Act requests to obtain redacted information. The group claimed it was stymied because the FDA responded with incomplete information or took so long to reply that some individuals were no longer serving on advisory committees.
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.
Similarly, of the resumes posted for the Center for Biologics Evaluation and Research committee members, 49 had redactions, or nearly 86 percent. And of the 128 resumes posted for members of Center for Devices and Radiological Health committees, 126 have redactions, or more than 98 percent, according to the lawsuit.
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.
As an example, Dr. Michael Carome, who heads Public Citizen’s Health Research Group, said he has served as an advisory committee member and told the FDA that his resume could be made public without any redactions. Yet when the FDA posted his resume, it had been redacted.
“The agency redacted my military awards and service and the amount of one National Kidney Foundation grant long since closed out,” he said. “The notion that releasing this information would be an invasion of privacy, or that it was confidential would be hard to understand, anyway. But after I specifically had stated that the (resume) could be posted in full, it is ridiculous.”
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Unfortunately, this shows how big corporations are allowed to suppress the rights of everyday citizens, and how the FDA may become the tool of the drug and medical device industry instead of protector of the public. First we saw Bush administration’s 2007 “fast tracking” drugs through the approval process – and we saw funding of the FDA processes by a Pharm/Device “use tax”. Now conflicts of interest of the approval committees are to remain hidden from public consumers. Result: now FDA drug/device approval has not just a fast track but its own Bullet Train, with medical company engineers at the wheel. For a spotlight on the honesty of the whole process, read the October 2012 Senate Finance Committee report on Medtronic/InFuse and medical researchers.
Couple this with Federal Preemption (viz., Riegel v Medtronic, Inc., 2008), and consumers who are injured by faulty products with hidden defects/risks have little chance to ever be made whole again. Once a product is approved by FDA as ‘safe and effective’ the manufacturer is shielded from products liability no matter how strong the evidence showing bad design, faulty research or fraudulently misrepresented data submitted to FDA.
Our only hope is to elect lawmakers who are honest and resolute enough to protect their constituents to impose standards and restraints, despite attempts by big money corporations to control lawmaking. We are grateful for the actions of Public Citizen, Dr. Sydney Wolff and for the continued spirit of Ralph Nader.
How many panel members relatives are paid by hedge funds that are shorting the drug company stock? We’ll never know.
Jaydee, with the history of insider trading going on at FDA maybe the more appropriate question is who in the agency is shorting the stock.
http://www.cbsnews.com/news/how-the-fda-brought-its-insider-trading-scandal-on-itself/
yeah, would like to meet the fools that gave the ‘OK’ for mesh to be put in anyone…..ALL MESH, started with hernia mesh and went from there…..different names so no lawsuit if you didn’t have the correct mesh, ’cause that mesh is a different mesh, there is no proof of what it does because there isn’t a DR to help a patient prove it…… :/
If anybody ever saw the voluminous forms experts have to complete even before they are vetted it’s a wonder anybody would want to serve at all. Bigger fish to fry, Sid.
If you are one of the ones who end up suffering because a drug/device company had someone on the board who had some sort of financial interest in that drug/device, I don’t think you’d feel the same.