March 24,2009

Grassley works to protect FDA whistleblowers

WASHINGTON – Senator Chuck Grassley today said that employees of the Food and
Drug Administration deserve clarification from the Acting Commissioner about their ability to
communicate with Congress and the Inspector General following a memo issued last week that
warned employees about releasing information.

“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,” Grassley said. “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.”

Grassley is a longtime advocate for whistleblower protections for federal employees. He
co-authored the Whistleblower Protection Act of 1989, and has 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 during the last five years.

Last month, Grassley urged President Obama to have a Rose Garden ceremony honoring
federal whistleblowers to send a message from the top of the executive branch to the bottom that
“speaking the truth” deserves rewards not reprisals for exposing mismanagement and fraud,
waste and abuse of tax dollars. This month, Grassley sharply protested the President’s signing
statement on the American Recovery and Reinvestment Act, the economic stimulus bill, for the
way it contradicts campaign pledges and promises to protect whistleblowers.

The text of the letter Grassley sent today to the Acting Commissioner of the Food and
Drug Administration is below.

March 24, 2009

Frank M. Torti, MD, MPH
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Torti:

As a senior member of the United States Senate and the Ranking Member of the
Committee on Finance (Committee), I have a duty under the Constitution to conduct oversight
into the actions of executive branch agencies, including the activities of the Food and Drug
Administration (FDA/Agency). In this capacity, I work to ensure that FDA is completing its
mission to protect the public’s health and makes responsible use of the public funding provided
for medical studies. Decisions made by FDA often form the basis for action taken by the
Medicaid and Medicare programs which fall under the exclusive jurisdiction of the Committee.

I am concerned about a recent memorandum you sent to FDA employees warning them
of their obligations to keep certain information confidential. While I appreciate the fact that
some information, including certain business trade secrets, needs to be protected from
unauthorized disclosures, I have serious concerns that your memorandum goes beyond legitimate
privacy concerns and appears to run contrary to many statutes protecting executive branch
communications with members of Congress.

Specifically, your memorandum notes that certain information acquired from businesses
and industry is protected as confidential and may only be disclosed in limited circumstances.
Your memorandum cited the Food, Drug, and Cosmetic Act, the Freedom of Information Act
(FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations as the
controlling authority for determining when a document or information may be disclosed. You
added that FDA employees who violate these provisions may face disciplinary sanctions and
criminal liability.

I appreciate your concerns with protecting confidential information from unauthorized
disclosures. These protections play an important role in allowing business and industry to work
cooperatively with regulatory agencies. However, I am concerned with the timing of your
memorandum, given some recent high profile matters concerning your Agency and the release of
information that has shown failures in FDA’s regulatory mission. My concern is that this recent
memorandum could be viewed by some as an effort to chill and/or prevent FDA employees from
exercising their rights under whistleblower protection laws to communicate with Congress.

Fox example, internal FDA documents released recently seem to suggest that lobbying
may have influenced the decision in a device approval.[1] Another internal document shows that
a physician was removed for inappropriate reasons from a recent safety panel.[2] In both, cases, I
do not believe that Congress would be notified unless whistleblowers spoke up.

Dr. Torti, I have been an outspoken advocate for whistleblowers and have authored
numerous whistleblower protection provisions. Whistleblowers are some of the most patriotic
people I know—men and women who labor, often anonymously, to let Congress and the
American people know when the Government isn’t working so we can fix it. As such, it would
have been prudent for you to include a section in your memorandum that outlines the interplay
between protected confidential and trade secret information and making protected disclosures to
Congress and/or Inspectors General in accordance with the whistleblower protection laws.
Absent such a discussion, many FDA employees could take this memo to mean that they could
be criminally sanctioned for providing information to Congress.

As you may be aware, 18 U.S.C. § 1505 states, in pertinent part:

Whoever corruptly, or by threats or force, or by any threatening letter or
communication influences, obstructs, or impedes or endeavors to
influence, obstruct, or impede the due and proper administration of the law
under which any pending proceeding is being had before any department
or agency of the United States, or the due and proper exercise of the power
of inquiry under which any inquiry or investigation is being had by either
House, or any committee of either House or any joint committee of the

Shall be fined under this title, imprisoned not more than 5 years or, if the
offense involves international or domestic terrorism (as defined in section
2331), imprisoned not more than 8 years, or both.

Additionally, denying or interfering with employees' rights to furnish information to
Congress is also against the law. I have attached another copy of 5 U.S.C. § 7211 to this letter
for your reference. That law states:

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.

Finally, federal officials who deny or interfere with employees' rights to furnish
information to Congress are not entitled to have their salaries paid by taxpayers' dollars. I have
attached a copy of P.L. 111-5 § 714 to this letter for your reference, which states:

No part of any appropriation contained in this or any other Act shall be
available for the payment of the salary of any officer or employee of the
Federal Government, who -

(1) prohibits or prevents, or attempts or threatens to prohibit or prevent, any
other officer or employee of the Federal Government from having any
direct oral or written communication or contact with any Member,
committee, or subcommittee of the Congress in connection with any
matter pertaining to the employment of such other officer or employee or
pertaining to the department or agency of such other officer or employee
in any way, irrespective of whether such communication or contact is at
the initiative of such other officer or employee or in response to the
request or inquiry of such Member, committee, or subcommittee; or

(2) removes, suspends from duty without pay, demotes, reduces in rank,
seniority, stats, pay, or performance of efficiency rating, denies promotion
to, relocates, reassigns, transfers, disciplines, or discriminates in regard to
any employment right, entitlement, or benefit, or any term or condition of
employment of, any other officer or employee of the Federal Government,
or attempts or threatens to commit any of the foregoing actions with
respect to such other officer or employee, by reason of any communication
or contact of such other officer or employee with any Member, committee,
or subcommittee of the Congress as described in paragraph (1).

FDA employees have the right to talk to Congress and to provide Congress with
information free and clear of Agency influence. Further, these employees have the right to be
free from fear of retaliation or reprisal. You should review these important statutes and
reevaluate the message sent by your memorandum. I believe that you should take the further
step of issuing a second memorandum to FDA employees outlining their rights and
whistleblower protections, as well as outlining the FDA’s responsibilities for respecting those
protected disclosures. Such a memorandum would go a long way toward ensuring that the FDA
remains “committed to the principles of open Government and transparency” as you stated in
your memorandum.


Charles E. Grassley
Ranking Member

[1] Mundy, Alicia, “Political Lobbying Drove FDA Process,” The Wall Street Journal, 6 March 2009.
[2] Russel, John, “Lilly faces inquiries over drugs Alimta, Effient,”, 28 Feb 2009.