Scientists and doctors at the Food & Drug Administration wrote a letter April 2 to President Barack Obama to ask that he hold former and current senior officials at the federal watchdog agency accountable for their wrongdoing.
The letter details numerous instances in which FDA officials violated agency rules and, in some cases, federal law. It goes on to say that “sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long.”
“Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA,” according to the letter. “As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency. But the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.”
The letter cites numerous cases of malfeasance, including:
- FDA’s decision to restrict access to Plan B, the so-called “morning after drug,” which a federal judge deemed (PDF) tainted by improper ideological pressure;
- Distortions of the scientific review of medical devices by top officials at the agency’s Center for Devices and Radiological Health and retaliation (PDF) against whistleblowers who brought the distortions to light;
- “Improper political influence” driving Office of Device Evaluation director Donna-Bea Tillman to approve a medical device used for the detection of breast cancer, contrary to the recommendations of all of the FDA experts involved. “Dr. Tillman’s decision to overrule the FDA experts ‘followed a phone call from a Connecticut congressman [Christopher Shays],'” according to the letter, citing the New York Times;
- Allegations that FDA officials caved in to ReGen Biologics Inc.’s intensive lobbying effort to get fast-track 510(k) approval for its Menaflex knee implant and gave the company preferential treatment, despite objections by FDA experts;
- Then-acting commissioner Torti’s FDA-wide email “admonishing FDA employees that they ‘must comply with … obligations to keep certain information … confidential … [including] e-mail to and from employees within FDA [that document the] deliberative process’ and threatening that ‘violation … can result in disciplinary sanctions and/or individual criminal liability;'”
- Efforts by top officials, including von Eschenbach, Torti, CDRH director Daniel Schultz and assistant commissioner for accountability and integrity William McConagha, to “cover up (PDF) their attempts to improperly influence, obstruct, impede and distort the due and proper administration of the FDA scientific regulatory process involving a knee implant device”—Menaflex. That included attempts by Schultz and FDA lawyers to conceal the fact that two authors of a publication presented in support of the knee implant were affiliated with ReGen Biologics.
- Schultz’s approval of a medical device against the unanimous opinion of his scientific staff, which overruled more than 20 FDA scientists, medical officers and management staff, according to the letter, which cited a New York Times description of the episode as “the first time in the agency’s history that a director approved a device in the face of unanimous opposition from staff scientists and administrators beneath him.”
- Tillman’s approval of a medical device “that has failed to demonstrate any clinical benefit,” showed “trends toward higher risks of death” and bore “an eerie resemblance to another device, Intergel, an anti-scarring device intended for pelvic surgeries that also demonstrated reduced scarring without clinically validated outcomes. … Less than two years after Intergel was approved [by Dr. Schultz], the company removed the product from the market due to reports of post-operative pain, foreign body reactions and tissue scarring requiring repeat surgery, including three deaths among women who received it.”
The doctors and scientists who wrote the letter, whose signatures were redacted from the public version, said they hope Obama’s appointments of Margaret “Hamburg as FDA commissioner and Joshua Sharfstein as principal deputy commissioner heralds a new era of reform at the agency.
“FDA must carry out its work in a transparent manner based on sound science in order to improve the lives of all Americans, reduce health care costs, and expand health care access,” the letter stated. “The clearance/approval of medical devices that were not made in accordance with the laws, rules and regulations, need to be re-visited. Furthermore, those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly.”
All FDA employees who are committed to public integrity, who follow the laws, rules and regulations, who use science to promote public safety and health, and who have the courage and patriotism to speak out, must be protected and must have their professional lives restored. We ask that you accept nothing less.”