Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Resumed

Floor Speech

BREAK IN TRANSCRIPT

Mr. GRASSLEY. Mr. President, today we will be considering and are considering a vital piece of legislation that not only includes all four user fee agreements but also includes policy proposals to improve the Food and Drug Administration review and approval of medical products, particularly in the pharmaceutical supply chain.

In 2008, when Senator Kennedy was still in the Senate, he and I introduced the Drug and Device Accountability Act. This legislation was largely in response to the extensive oversight I conducted on the Food and Drug Administration. During these investigations, I identified serious problems at the FDA that included severe weaknesses in the inspection process, delays in informing the public of emerging safety problems, and lack of enforcement authority.

Based on these findings, the Kennedy-Grassley legislation included provisions to ensure the safety of drugs, including foreign-manufactured drugs. It would have expanded FDA's authority to inspect foreign manufacturers and importers on a risk-based schedule. It would have required all manufacturers to register with the agency so they can properly identify the number of manufacturers and where they are located. This would have ensured that when a crisis occurs, we can quickly locate the questionable facility. And it would have increased civil and criminal penalties with respect to violations.

Unfortunately, Senator Kennedy and I never had an opportunity to debate this legislation, let alone cast a vote on it. However, roughly a year ago Senators Harkin and Enzi forged a bipartisan working group to address these challenges. The group has worked tirelessly to produce a bipartisan bill that modernizes FDA's authority to ensure that drug products coming into the United States are safe for American patients.

This bill incorporates many provisions in the Drug and Device Accountability Act Senator Kennedy and I introduced. It increases penalties for knowingly and intentionally counterfeiting drug products. It requires electronic submission of certain key information by a drug importer as a condition to grant entry.

I would like to have seen additional enforcement tools included in the legislation. For example, granting FDA the authority to destroy unsafe products that are refused admission into our country would enhance FDA's ability to protect the public from tainted products.

Likewise, I think FDA should have been granted subpoena authority and have it on a par with other Federal law enforcement authorities because currently FDA lacks subpoena authority and has to go through the Department of Justice, which is time-consuming and burdensome.

Ultimately, this legislation is a needed step in the right direction toward securing our supply chain. This legislation did not address a top priority of mine; that is, ensuring whistleblowers have adequate protections. Four months ago, my office learned of an abusive treatment by the Food and Drug Administration toward whistleblowers due to their protected communications with Congress, more specifically with the office of this Senator. Once the agency learned of the communications, it began actively monitoring and observing employees' personal e-mail accounts for 2 years until the agency was able to have the employee fired.

Regrettably, I was not shocked to learn that the FDA was mistreating whistleblowers within this agency as it has done on more than the one occasion in the past that I have identified. What makes the example different and worse is that the FDA intentionally went after an employee because they knew that employee had no protection under the Whistleblower Protection Act.

The employee in question happened to be a member of the Public Health Service--the title is the Public Health Service Commissioned Corps. Because of the decision from the Court of Federal Claims, those employees are, in the Public Health Service, along with other members of the uniformed services, not covered by Federal employee whistleblower protections.

In 2009, the Court of Federal Claims held in Verbeck v. United States that an officer in the Public Health Service Commissioned Corps is a member of the uniformed services and as such is not covered under the Civilian Whistleblower Protection Act nor the Military Whistleblower Protection Act. This same logic extends to the commissioned corps of NOAA. So under this precedent, officers of the Public Health Service and NOAA currently have no whistleblower protection under Federal law.

This is particularly problematic when we consider that the Public Health Service and NOAA officers can be detailed to agencies such as the Food and Drug Administration or the Centers for Disease Control. That is the case here where that Public Health Service officer was working with FDA. At FDA they have to work side by side with civilian employees doing critical work to review and approve drugs, oversee medical devices, and even work on infectious diseases. However, unlike their civilian colleagues sitting right beside them, if these employees uncover wrongdoing, waste, fraud, and abuse, they can be retaliated against by the agency and have no recourse for it.

This is wrong and needs to be fixed. Whistleblowers point out waste, fraud, and abuse when no one else will. They do so while risking their professional careers. Whistleblowers have played a critical role in exposing government failures, and retaliation against whistleblowers should never be tolerated whether they are in the Public Health Service or otherwise.

For this reason, I will offer an amendment that expands whistleblower protection for uniformed employees of the Public Health Service. It corrects the anomaly pointed out in the Court of Federal Claims and ensures that officers in the Public Health Service have some baseline whistleblower protection. It expressly includes the commissioned corps of the Public Health Service within the protections of the Military Whistleblower Protection Act. This is consistent with the structure of the commissioned corps functioning like a military organization and matches the fact that these officers receive military-like benefits and retirement.

All Federal employees should feel comfortable expressing their opinion both inside the agency and to those of us in Congress. The inclusion of this language will ensure those opinions receive appropriate protections. I want to take this opportunity to express my appreciation to Senator Harkin and Senator Enzi for their commitment and effort over the years to reform and improve the Food and Drug Administration.

We have to do what we can to protect whistleblowers. They know where the skeletons are buried. They and enterprising journalists come to us in Congress so we can investigate. We need those sources of information.

BREAK IN TRANSCRIPT

Source