Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mr. GRASSLEY. Mr. President, first of all, I congratulate my colleague from Iowa and my colleague from Wyoming for the bipartisanship of this legislation.

The FDA amendments of 2007 mandated basic public results reporting for all clinical trials supporting FDA-approved drugs and devices. Clinical trials results help both patients and doctors understand the benefits and efficacy of a particular medical product.

Moreover, a July 2011 FDA report stated:

Understanding variable characteristics in clinical trial sites is becoming increasingly important because of the international nature of current clinical trials. The sources of differences in efficacy results between the U.S. and foreign clinical trials sites have yet to be determined, but differences rooted in the conduct of the clinical trial should be evaluated.

It has been 5 years since the passage of the FDA Amendments Act, and the National Institutes of Health is still in the process of writing proposed regulations. The clinicaltrials.gov program and title VIII of the FDA Amendments Act were considered major reforms and helped science information advances. If they are not being implemented well or adequately enforced, society will fail to reap the full benefits of the billions of dollars in good medical science research.

This amendment before the Senate will impose a deadline by which the NIH will finalize both the proposed and final regulations. Further, 2 years after the regulation has been in place, the Government Accountability Office will conduct a study on compliance with regulations and will look at, among other things, whether the applicable clinical trial is conducted domestically, in foreign sites, or in a combination of sites.

The rapid increase in trials being run overseas makes it imperative that the Government Accountability Office investigate this matter.

Currently, ``80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.'' The ``FDA inspected 1.9 percent of domestic clinical trial sites and 0.7 percent of foreign clinical trial sites.'' We need stronger reporting requirements to ensure we understand what the implications are of this move to having so many trials conducted overseas. I encourage my colleagues to support this important amendment.

Before I move on, I wish to talk about another amendment I am a cosponsor of, which is an amendment offered by Senator Portman that will make dangerous synthetic drugs such as K2 and bath salts schedule I narcotics. I have worked for over a year now to get this legislation passed through the Senate after a constituent of mine named David Rozga committed suicide shortly after smoking K2 with some friends nearly 2 years ago.

I introduced the David Mitchell Rozga Act in March of 2011, and the Senate Judiciary Committee unanimously passed it out of committee along with two other related bills sponsored by Senator Schumer and Senator Klobuchar last July. Since that time, the use of synthetic drugs has grown very rapidly, with the number of calls into poison control centers going from as few as 19 in the year 2009 to over 6,000 in the year 2011.

The House passed their version of this bill last December on a strong bipartisan vote, but one Senator has blocked consideration of this legislation in this Chamber up to now.

So I am grateful we are finally able to have a vote on this issue, and I urge passage of the Portman amendment as well.

Madam President, I wish to go to another amendment, if that would be appropriate at this time.

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Mr. GRASSLEY. Madam President, the bill before us, S. 3187, did not address a top priority of mine, and that is ensuring whistleblowers have adequate protections.

Four months ago my office learned of a very abusive treatment by the FDA on certain whistleblowers due to those whistleblowers' protected communications with Congress and, more specifically, with this Senator's office. Once the agency learned of the communication, even though they were on personal e-mail, it began actively monitoring and observing employees' personal e-mail, as one might expect, and they observed those e-mail accounts for 2 years--for a whole 2 years--until the agency was able to have the employee fired.

Whistleblowers shouldn't be fired for doing what is patriotic; that is, reporting wrongdoing to Congress. Regrettably, I was not shocked to learn that the FDA was mistreating whistleblowers within its agency, as it has done on more than one occasion, and as I have pointed out to my colleagues. I have been reporting those things ever since the Vioxx situation of 2004, I believe.

What makes this example different, though--and even worse--is the FDA intentionally went after an employee because it knew this employee was not covered by the Whistleblower Protection Act. Now, it might surprise some of my colleagues that all employees aren't covered by the Whistleblower Protection Act. This 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--meaning the Public Health Service along with other members of the uniformed services--are not covered by the Federal employee whistleblower protections.

I think the court case was wrong, but anyway, that is the way the Court of Federal Claims ruled. That ruling came as a result of the Verbeck v. United States case, and the Court of Federal Claims held that an officer in the Public Health Service Commissioned Corps is a member of the uniformed service and as such is not covered by the civilian Whistleblower Protection Act, nor even the Military Whistleblower Protection Act. This same logic extends to the commissioned corps of the National Oceanic and Atmospheric Administration as well. So under the precedent of this Verbeck case, the officers of both 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 FDC or the Centers for Disease Control. There, these officers, working in another agency, happen to work side-by-side with civilian employees of that agency doing very critical work to review and approve drugs, oversee medical devices, and even work on infectious diseases. However, unlike their civilian colleagues who are employees of that agency and who are sitting right next to them, if these employees uncover wrongdoing, waste, fraud, and abuse, they can be retaliated against by the agency and have no recourse for it. That is exactly what happened to this Public Health Service employee working in the Food and Drug Administration when they reported wrongdoing at that agency to Congress. They did it by personal e-mail, and the FDA got on to it and then fired the one employee who was reporting to Congress but did not fire the employees who were protected by the Whistleblower Protection Act. So that is why I say this is wrong, and it needs to be fixed. This amendment will fix it.

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 protection 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 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 in 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' concern that is not related to the underlying bill. So I hope to be able to address that 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 opinions both inside the agency they work for as well as to Congress. The inclusion of this language will ensure those opinions receive appropriate protections.

I wish to take this opportunity, as I did in my opening comments on these two amendments, to express my appreciation to Senators HARKIN and ENZI and their commitment and efforts over the years to reform and improve the FDA.

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