Grassley:  FDA legislation now better protects whistleblowers, charts path to posting of clinical trials.

Senate proposal also targets counterfeit drugs and requires electronic import records

 

WASHINGTON - Senators late yesterday agreed to add two provisions sponsored by Senator Chuck Grassley to legislation that will renew user fee agreements that fund the Food and Drug Administration.

 

The first addition is a whistleblower reform he authored based on congressional oversight of the FDA.  The second is a plan to see that clinical trial results are posted when the National Institutes of Health issues regulations, as it was called upon to do in a law enacted five years ago.

 

Grassley said more should be done to protect FDA whistleblowers, but the part of his reform proposal that's now been made part of the Senate FDA bill would expand protections for uniformed employees of the Public Health Service.  Earlier this year, Grassley was contacted by FDA whistleblowers after they were negatively targeted by FDA officials for communicating with his office about concerns regarding the FDA.  The FDA read messages on the employees' personal email accounts to learn about the communication.

 

"The situation was egregious for a number of reasons, including the fact that the FDA went after an employee who wasn't covered by the Whistleblower Protection Act," Grassley said.  "Whistleblowers identify fraud, waste and abuse, often when no one else will, and risk their professional careers to do so.  Those inside the federal government should feel comfortable expressing opinions both inside agencies and to those of us in Congress."

 

Grassley's proposal to push the National Institutes of Health to publish regulations on clinical trials as was required in the reauthorization of user fees five years ago will require a study by the Government Accountability Office two years after the regulations are final in order to make certain the posting of clinical trial results occurs as intended.

 

"The goal is to give patients, researchers and health care professionals access to valuable information that could help to build understanding of the efficacy and safety of drugs and medical devices," Grassley said.

 

Grassley's clinical trials provisions are supported by the Union of Concerned Scientists, the Consumer Federation of America, U.S. PIRG, Public Citizen, and NRC for Women & Families.

 

Separately, the overall FDA bill, the Prescription Drug User Fee Act, contains legislation authored by Grassley and Senator Patrick Leahy to increase penalties for counterfeiting drug products.  It also contains legislative language that will heighten the scrutiny of imported drugs through electronic records.  This language comes from legislation Grassley previously co-authored with the late Senator Ted Kennedy.

 

Grassley also offered an amendment to the FDA bill with Senator Kohl and Senator Blumenthal to try to combat excessive use of antipsychotics in nursing homes.  "Our effort would empower nursing home residents and their loved ones in decision-making about what drugs are prescribed for them," he said.

 

Otherwise, Grassley said he had hoped the 2012 reauthorization of the Prescription Drug User Fee Act would give the FDA its own subpoena authority so that it no longer would need to navigate a cumbersome process at the Department of Justice.  He said the FDA also should be given the FDA authority to destroy unsafe products that are refused admission to the United States.

 

In response to consumers, the drug industry and the FDA, Congress first enacted the Prescription Drug User Fee Act in 1992 to try to speed up the drug approval process.  The fees raise supplement federal appropriations instead of replacing them.

 

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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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Floor Statement of U.S. Senator Chuck Grassley

Celebrating the Life of Katie Beckett

Tuesday, May 22, 2012

Mr. President, I come to the floor today to celebrate the life of Katie Beckett.  Never has the word "inspiration" been used more appropriately in describing someone, and today, I am grateful to be able to recognize the inspirational life of Katie Beckett.

Mary Katherine "Katie" Beckett was born in Cedar Rapids, Iowa on March 9, 1978.  Five months after she was born, Katie contracted viral encephalitis followed by grand mal seizures.  The encephalitis caused damage to her central nervous system and her respiratory system, and she was attached to a ventilator.  She would be almost two years old before she could breathe on her own.

Under Medicaid law of the time, Katie could only receive care through Medicaid if she remained in the hospital even though she was able to receive care at home.  Iowa Congressman Tom Tauke heard of Katie's situation and realized that it made no sense to keep a child in the hospital who could be at home with her family.  He worked to convince the Administration that the system should be changed to allow states to provide Medicaid to children receiving care in their homes.

Ultimately, President Reagan took up Katie's cause intervening so that Katie could receive treatment at home and still be covered under Medicaid.  This change in policy became known as "Katie Beckett waivers" and, to date, more than a half million disabled children have been able to receive care in their homes with their families rather than being forced into hospitals and institutions.

But Katie's story doesn't end there.  As Katie grew up, as she battled to establish her own place in society as a young American with disabilities, she realized she had an opportunity to serve others who faced similar challenges.  In her own words, this is from a piece Katie wrote in 2002 titled "Whatever happened to Katie Beckett?"

"I started my advocacy career at age ten.  It was not my choice but rather a path chosen for me. It was not until I was twelve or thirteen that I realized the important work I was able to do because I was who I was and how much this work helped other kids."

Katie graduated with a degree in English from Mount Mercy College in Cedar Rapids.  She lived in the community.  She wanted to be a teacher and write novels for young people.  She was fiercely independent, sometimes to the consternation of her mother, Julie.  She was quick witted and funny and loved a good cup of coffee.  She lived her life as a tireless advocate for the disabled.  She testified before Congress several times and was a contributing voice on numerous groups dedicated to disability policy.  When we took up policy proposals like the Family Opportunity Act and Money Follows the Person, we wanted Katie's perspective, and we depended on her advocacy in the community to get those laws passed.

Katie was the living embodiment of a person with disabilities participating and contributing in society.  Mr. President, on Friday, May 18, Katie went home to be with the Lord.

She leaves behind thousands of lives touched by her presence.  A light may go out, but a light lives on in those of us fortunate to have known Katie Beckett.  We remain inspired to work every day to create opportunities for the disabled to participate and contribute and live the life of service and dedication that Katie did.  Katie remains an inspiration.

Monday, May 21, 2012

Here is information about Senator Grassley's schedule this week.  The Senate is in session.

Senator Grassley will meet with Iowans from Iowa Citizens for Community Improvement, the Iowa Telecommunications Association, the Leukemia and Lymphoma Society, the American College of Emergency Physicians, the Iowa Rural Letter Carriers, the Appraisal Institute, and the Paper Recycling Coalition.

Senator Grassley also will meet with Iowa families visiting Washington from Johnston, Des Moines, Ankeny, and Iowa City.

Senator Grassley will be a guest this week on public affairs programs hosted by Ryan Schlader of WMT Radio in Cedar Rapids and Mike Adams of AgriTalk, which airs on 13 Iowa radio stations.

On Monday, May 21, at 2:30 p.m. (ET), in Dirksen 226, Senator Grassley will speak to the Whistleblower, Civil and Human Rights Summit.

Senator Grassley will answer questions and respond to comments via Skype with fourth graders at MOC-Floyd Valley Community Schools in Hospers on Tuesday, May 22, at 1:30 p.m. (CT), and with students in the contemporary issues class at Marshalltown High School on Thursday, May 24, at 8:30 a.m. (CT).

On Wednesday, May 23, at 10 a.m. (ET), in Dirksen 226, Senator Grassley will participate in a hearing of the Judiciary Subcommittee on Administrative Oversight and the courts titled "Protecting Our Children:  The Importance of Training Child Protection Professionals."

On Wednesday, May 23, at 1:15 p.m. (ET), in the Capitol Visitors Center, SVC-215, Senator Grassley will speak about the impact of intellectual property laws on jobs at an event of the U.S. Chamber of Commerce's Global Intellectual Property Center.  The Center will be releasing a new study.

On Wednesday, May 23, at 2:30 p.m. (ET), in Dirksen 226, Senator Grassley will participate in a hearing of the Judiciary Committee to consider nominations to the federal judiciary.

On Thursday, May 24, at 10 a.m. (ET), in Dirksen 226, Senator Grassley will participate in the weekly executive business meeting of the Judiciary Committee.  Two legislative proposals may be considered:  S.2076, the Local Courthouse Safety Act of 2012, sponsored by Senators Al Franken, Lindsay Graham, Amy Klobuchar, John Cornyn, Sheldon Whitehouse and Richard Blumenthal, and S.2370, the Small Business Reorganization Efficiency and Clarity Act, sponsored by Senators Grassley and Sheldon Whitehouse.