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Senate debate on the FDA user fees bill

Floor Statement of U.S. Senator Chuck Grassley
Prescription Drug User Fee Act Reauthorization
Wednesday, May 23, 2012

Mr. President, today we will be 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’s (FDA) review and approval of medical products, particularly in the pharmaceutical supply chain.

In 2008, Senator Kennedy and I introduced the Drug and Device Accountability Act.   This legislation was largely in response to the extensive oversight I conducted of the FDA.  During these investigations, I identified serious problems at the FDA that included:
•           Severe weaknesses in the inspection process;
•           Delays of informing the public of emerging safety problems; and
•           Lack of enforcement authority

Based on these findings, our 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 we 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, we 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 bi-partisan working group to address these challenges.

The group has worked tirelessly to produce a bi-partisan 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 introduced in the Drug and Device Accountability Act Senator Kennedy and I introduced.
•           It increases penalties for knowingly and intentionally counterfeiting drug products; and
•           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 the United States would enhance FDA’s ability to protect the public from tainted products.

Likewise, granting FDA subpoena authority would bring FDA up to par with all other federal agencies’ enforcement authorities.  Currently, FDA lacks subpoena authority and as such must 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, ensuring whistleblowers have adequate protections.

Four months ago my office learned of the abusive treatment by the FDA on whistleblowers due to protected communications with Congress, more specifically, with my office.   Once the agency learned of the communication, it began actively monitoring and observing employees personal email accounts for two years until the agency was able to have the employee fired.

Regrettably, I was not shocked to learn that FDA was mistreating whistleblowers within its agency, as it has done so on more than one occasion in the past.

What makes this example different and worse is that FDA intentionally went after an employee because it knew that employee was not covered by the Whistleblower Protection Act (WPA).  The employee in question was a member of the Public Health Service Commissioned Corps and because of a decision from the Court of Federal Claims, these employees, along with other members of the uniformed services, are 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’s commissioned corps is a member of the uniformed service and as such, is not covered under the civilian Whistleblower Protection Act (WPA) or the Military Whistleblower Protection Act.  This same logic extends to the commissioned corps of the National Oceanic and Atmospheric Administration.  So, under this precedent, the officers of both the PHS and NOAA currently have no whistleblower protections under federal law.

This is particularly problematic when you consider that PHS and NOAA officers can be detailed to agencies like the FDA or CDC.  There, they 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 next to them, if these employees uncover wrongdoing, waste, fraud or 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 fraud, waste and abuse when no one else will, and 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.

For this reason, I offered an amendment that expands whistleblower protections for uniformed employees of the Public Health Service.  It corrects the anomaly pointed out by the Court of Federal Claims and ensures that Officers in the Public Health Service have some baseline whistleblower protections.  It expressly includes the commissioned corps of the PHS 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.

Unfortunately, this amendment, which I was able to get into this legislation, only covers employees of the Public Health Service.  It does not address the commissioned corps of NOAA because of other senators’ concerns that it is not related to the underlying bill.   I hope that we can address this remaining gap in whistleblower protections in the near future so that all employees of the federal government are covered.

All federal employees should feel comfortable expressing their opinion, both inside the Agency and to Congress.   The inclusion of this language will ensure those opinions receive appropriate protections.

I want to take this opportunity to express my appreciation for Senators Harkin and Enzi and their commitment and efforts over the years to reform and improve the FDA.

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