Protection of FDA Whistleblowers

By: John Jordan, CIS Senior Compliance Associate
johnjordan@cis-partners.com

A whistleblower is someone who reports the misconduct of a certain entity. The misconduct could be a violation of a law, rule, regulation, and/or a direct threat to public interest, such as fraud, health/safety violations, and corruption. Senator Chuck Grassley, Republican of Iowa, has been a vocal advocate in the protection of FDA Whistleblowers. Grassley is a longtime advocate of whistleblower protections for federal employees. He co-authored the Whistleblower Protection Act of 1989, and has since co-sponsored legislation to update the law. Grassley also conducts extensive congressional oversight. He has sought administrative and legislative reforms to address problems he has revealed at the Food and Drug Administration (FDA) during the last five years.

Last month, Senator Grassley protested a signing statement President Obama attached to the American Recovery and Reinvestment Act, the $410 billion spending bill that was issued as a stimulus to our nation's economy, for the way it contradicts the protection of whistleblowers. President Obama’s signing statement says,

“I do not interpret this provision to detract from my authority to direct the
heads of executive departments to supervise, control and correct employees’
communications with the Congress in cases where such communications would be
unlawful or would reveal information that is properly privileged or otherwise
confidential.”(1)

The senator thinks the signing statement sends a message from the President that will prevent whistleblowers from coming out to report misconduct. Senator Grassley also stated last month that employees of the FDA deserve clarification from their Acting Commissioner about their ability to communicate with Congress and the Inspector General, following a memo issued last week, warning employees about releasing information.

Grassley further goes on about the protection of whistleblowers by stating,

"Federal laws protect whistleblowers and allow people who work in the federal
bureaucracy to discuss what's happening inside an agency with other officials.
Attempts to silence whistleblowers are illegal. If the memo sent last week
was intended to have a chilling effect on FDA employees who want to speak up
about problems, then that memo is contrary to the President's call for open and
transparent government, and the Acting Commissioner needs to set the record
straight."(2)

In a letter to Dr. Frank Torti, Acting Commissioner of the FDA, Grassley states his feelings towards the protection of whistleblowers by saying, “The right of employees, individually or collectively, to petition Congress or a Member of Congress, or to furnish information to either House of Congress, or to a committee or Member thereof, may not be interfered with or denied.”(2) He asks for additional clarification of protection for whistleblowers, and outlines successful changes that whistleblowers have brought about.

Whistleblowers provide a check and balance that our organizations need. Without them companies could, knowingly or unknowingly, get away with violations that could have been prevented. Whistleblowers cause more organizations to be proactive in making sure they are compliant with the laws, rules, and regulations set in place for them. They also help the government in finding the organizations that cross the line of misconduct and must be punished for their actions. As Senator Grassely states, "FDA employees...have the right to be free from fear of retaliation or reprisal."(2)

Sources:
1. Obama Undercuts Whistle-Blowers, Senator Says:
http://www.nytimes.com/2009/03/17/us/politics/17signing.html?_r=1

2. Grassley Works to Protect FDA Whistleblowers: http://www.pharmaceuticalonline.com/article.mvc/Grassley-Works-To-Protect-FDA-Whistleblowers-0001