Alleged illegal practices at FDA’s medical device Office may be jeopardizing public safety

Armand Rossetti

Contributor

0 CommentsPrint ArticleSubscribe

The FDA directs the Center for Devices and Radiologic Health (CDRH), which is The Office in charge of regulating medical devices. Recently, a group of scientists who review device safety at the Office sent a troubling letter to US Representative John Dingell (D-MI), exposing alleged serious misconduct among several FDA and CDRH management personnel.

The letter highlighted the following alleged questionable practices, supported by extensive documentary evidence:

• CDRH managers with no clinical medical practice experience and no scientific or medical expertise have been ignoring safety and effectiveness concerns and scientific regulatory requirements;

• Managers have been violating the law by intimidating and coercing FDA scientific and medical experts to modify their technical reviews, conclusions and recommendations;

• FDA scientists were also coerced or intimidated to make safety and effectiveness determinations based on unsound evaluation methods, and to accept clinical and technical data that were not scientifically valid nor obtained in accordance with the law, e.g., data obtained without first seeking proper informed consent from human subjects;

• Managers are knowingly avoiding responsibility by failing to properly document their decisions in official Agency records;

• Managers have been refusing to permit scientists to revise flawed methods, and they have been demanding that scientists blindly follow protocol, by using past flawed conclusions as a basis for regulatory recommendations, for example:

• Employing invalid precedent that went against scientific and clinical evidence;
• Promulgating results based on repeatedly making the same regulatory and scientific mistakes; and
• Approving additional devices based on potentially unsafe predicate devices already on the market, rather that recalling those devices.

Reportedly, these illegal management activities are continuing, and they include 510(k) and PMA device approval policy violations as well. Moreover, the illegal practices under congressional investigation present an unwarranted and ongoing risk to public safety. According to the scientists who have exposed those CDRH management practices, it could take years before anyone might realize the nature and extent of the dangers involved with illegally approved medical devices.

Additional References with excerpts:

The Salt Lake Tribune

“The scientists said they reported their concerns to von Eschenbach in May. While the agency's assistant commissioner for integrity and accountability, William McConagha, found "convincing" evidence to support the allegations, no action has been taken, according to Dingell and Stupak. McConagha also may have recommended the removal of certain managers, the lawmakers said.”

Congressional Committee on Energy and Commerce News Release

“Our investigations have found that the FDA has allowed contaminated food and unsafe drugs to enter the market, and now serious allegations have been raised about the scientific integrity of the FDA medical device approval process,” Stupak said. “Although the FDA has launched its own investigation into this matter, no corrective action has been taken. The committee intends to learn what action the FDA plans to take to ensure the integrity of the medical device approval process and prevent retaliation against the scientists who blew the whistle on these activities…

In a letter sent today to FDA Commissioner Andrew C. von Eschenbach, Dingell and Stupak requested a briefing on what actions the Commissioner has taken to date and how the Commissioner intends to resolve all issues raised by the CDRH scientists and physicians.”

Click here to read the letter

FDA News Device Daily Bulletin

“Dingell and other lawmakers began an investigation into whether FDA managers ‘knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation of laws and regulations,’ according to a statement from the committee.”

ModernHealthcare.com

“Dingell and Stupak have sent a letter to FDA Commissioner Andrew von Eschenbach requesting a briefing on what actions the agency has taken to resolve issues raised by CDRH scientists and physicians. The inquiry broadens an ongoing investigation launched in early 2007 into the scientific integrity of the FDA approval process.”