Sen. Chuck Grassley (R-Iowa) launched an investigation into whistleblowers’ claims that the FDA systematically persecuted and spied on employees who voiced concerns over certain medical devices cleared for the U.S. market.
The plaintiffs are accusing the agency of ordering FDA physicians and scientists to ignore guidance documents, permitted managers to issue written threats of disciplinary action if employees didn’t change their opinions and recommendations to conform with management, made false statements in government documents and allowed manufacturers to market devices never approved by the FDA.
Grassley, the senior GOP lawmaker on the Senate Judiciary Committee, began looking into the allegations after a clutch of current and former FDA scientists filed a lawsuit accusing the agency of violating the 1st, 4th and 5th amendments in secretly monitoring communications and persecuting whistleblowers.
"The FDA has a poor track record of retaliating against whistleblowers," Grassley said in prepared remarks. "This situation appears to be more of the same."
In a 5-page letter to FDA commissioner Margaret Hamburg, Grassley expressed concerns over the agency’s mishandling of whistleblowers, including concerns that the agency used scathing employee evaluations to punish scientists who were exposed as part of the group.
While the FDA declined to comment on pending litigation, the agency responded to Sen. Grassley’s concerns, telling MassDevice in an email:
"We encourage staff to debate the scientific issues underlying the agency’s decision-making process and to voice disagreement when a decision is in conflict with their views," FDA spokeswoman Erica Jefferson told us. "However, at the same time, we want to emphasize that we take very seriously our responsibility to protect the confidential commercial information, including, for example, information concerning unapproved devices applications and the safety and effectiveness data in such applications, entrusted to the Agency by the companies we regulate."
The agency does have the right to monitor employee communications, and it is a crime for FDA employees to reveal confidential information about companies seeking approval for medical devices.
"The FDA follows the Federal Information Security Management Act (FISMA) of 2002 to ensure that sensitive agency information is protected against unauthorized access, use, disclosure, and other security threats," Jefferson told us. "As part of our public health mandate, FDA deals with sensitive information that is directly tied to the critical role we play in protecting the nation’s food supply and ensuring the safety and effectiveness of our medical products. FDA’s monitoring was designed to determine whether confidential information had been in appropriately released."
"The FDA went far beyond ‘routine monitoring,’" executive director of the National Whistleblowers Center and attorney for the whistleblowers Stephen Kohn said in prepared remarks. "They unconstitutionally targeted one group of employees simply because they had the guts to speak up about misconduct."
Last week, a group of 6 former and current FDA employees filed a lawsuit charging the agency with spying on private emails without due process or just compensation in violation of the 5th Amendment, conducting illegal search and seizure in order to create a chilling effect on the employees’ free speech in violation of the 1st and 4th Amendments and violating the plaintiff’s right to representation.
The lawsuit names agency leadership, including Hamburg and medical devices chief Jeffrey Shuren, as well as the U.S. Public Health Service, the Dept. of Health & Human Services and the federal government, according to court documents.
Grassley initially wrote to the FDA about allegations of whistleblower persecution in January 2009, after a group of scientists dubbed the "FDA 9" sent a letter complaining that employees were spied on and persecuted for raising concerns that the agency "ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions and recommendation in violation of the law."
In his latest letter, Grassley sent the FDA commissioner 10 questions that he’d like answered by mid-month in February, namely to identify who authorized the surveillance measures, the circumstances of each of the FDA 9’s employment with the agency, whether the agency obtained email passwords that allowed them to intercept messages that did not pass through government networks and whether the agency is currently monitoring any other employee email accounts, among other queries.
"Whistleblowers point out fraud, waste, and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic," Grassley wrote.
"It is not general agency practice to monitor its employees’ computers beyond the monitoring necessary for compliance with FISMA," Jefferson told MassDevice. "Whenever an individual logs onto the FDA computer system they are warned that their use of the system may be monitored, intercepted, or recorded in any manner and disclosed by and to authorized personnel. Before proceeding to use the system, they are required to affirmatively consent to such monitoring. Also, all FDA personnel are required to complete an annual computer system security awareness training module, during which this warning is reiterated.”
The lawsuit was filed last week in the U.S. District Court for the District of Colombia. Summons have been issued to federal agencies and employees, and answers are due by March 26.