Washington, DCPeople everywhere are writing, blogging and tweeting about the corruption letter penned by the US Food and Drug Administration (FDA). The FDA has now "certified" this letter, which comes as good news to lawyers and plaintiffs. But inquiring minds want to know who penned the letter—a secret FDA whistleblower?
According to the Wall Street Journal, it's no secret. The Journal reported in January 2009 that nine FDA scientists sent a letter to John Podesta, the transition team head of then President-elect Barack Obama, pleading that the agency be restructured due to FDA managers who "ordered, intimidated and coerced scientists to manipulate data in violation of the law." The agency, they wrote, is "fundamentally broken."
A similar letter was sent in October to the House Energy and Commerce Committee, but didn't provide as much detail regarding allegations about problems at the agency, including the threat of disciplinary action against scientists who dissent from management. The Journal further reported that FDA spokeswoman Judy Leon said the agency is "actively engaged in a process to explore the staff members' concerns and take appropriate action."
In November the Energy and Commerce Committee's Democratic and Republican leaders sent a letter regarding apparent conflicts of interest to the head of the FDA, Dr. Andrew von Eschenbach, who helmed the agency from 2006 until 2009. During that time, von Eschenbach was also director of the National Cancer Institute and founder of anti-cancer forum C-Change. One FDA report indicated that von Eschenbach was moved by political pressure in the drug approvals process, which is typically handled by scientific staff.
Back in 2005 a senior Republican senator told former President Bush that he should cancel his plan to allow von Eschenbach, a longtime friend of the Bush family and the director of the National Cancer Institute, to serve simultaneously as acting commissioner of food and drugs.
Much of the incentive for this corruption letter stems from a medical device. In 2009 the FDA said that former commissioner von Eschenbach and four New Jersey congressmen unduly influenced the approval for Menaflex, a medical device made by ReGen Biologics Inc., even though the agency's scientific reviewers deemed the device unsafe. One senator reportedly received $2,300 in 2008 from a ReGen executive.
This was the first time the FDA publicly questioned the process behind one of its approvals, admitted that a regulatory decision was influenced by politics and accused a former commissioner of questionable conduct.
Now that the FDA has certified the corruption letter, it will likely make plaintiffs' lawyers's jobs easier, as they won't have to go through numerous discovery demands. Instead, they can wave this letter in court. As for lawyers who defend drug companies, they can no longer rely on the FDA to say the product was "good to go."