POGO Calls for IG Investigation – FDA

From Project On Government Oversight          

 

FOR IMMEDIATE RELEASE

Contact: Danielle Brian , Executive Director, 202-347-1122 or Dr. Ned Feder, POGO Staff Scientist, 202-347-1122

POGO Calls for IG Investigation by FDA Commissioner Hamburg: Cozy Relationship with Manufacturers Blamed for Oversight Failures

The Project On Government Oversight (POGO) sent a letter to Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration on June 6, 2009, requesting she call for an investigation by the Department of Health and Human Services Inspector General. 

The issue is a specific instance of regulatory failure in the Center for Devices and Radiological Health (CDRH) at the FDA: the case of AM2PAT, Inc., a small company that manufactured and sold syringes. In December 2007, some of the syringes were found to have been contaminated by bacteria that caused deaths and serious illnesses. Two years later, two officials of AM2PAT were sentenced to prison after pleading guilty to crimes related to these events. At least four patients died and hundreds were harmed. Some suffered permanent, severe brain damage.

While senior officials of AM2PAT were clearly responsible for this tragedy, the FDA bears much of the blame for allowing it to happen.

“The role of the FDA in this case as a possible enabler of wrongdoing has not been publicly acknowledged either by the FDA or the Inspector General.   Accordingly, we ask that you request an investigation by the Inspector General of the Department of Health and Human Services. Such an investigation is long overdue,” said Danielle Brian , Executive Director in POGO’s letter.

As shown by its own records, the FDA had known for a long time about safety problems at AM2PAT. Repeatedly, for at least two years before it finally took decisive action, the FDA was given ample warning that AM2PAT was failing to ensure the safety of the company’s syringes. Months before the outbreak, a whistleblower working at the AM2PAT plant sent the FDA an email identifying herself and warning explicitly about unsuitable conditions in the plant.

In the letter to the Commissioner, POGO maintains that part of the reason for this failure is a culture within the FDA that habitually maintains a relationship with manufacturers that is too collegial and too tolerant. Too often, there is reluctance by the FDA to take corrective action stronger than a Warning Letter, even when stronger action is clearly indicated.  POGO acknowledges these failures also stem from the grossly inadequate resources available to the FDA for inspection and enforcement.

A thorough IG investigation of the AM2PAT failures will enable the IG to make recommend policy changes and reforms to the Secretary of HHS and the Congress necessary to ensure the public’s safety is protected against criminal misconduct and lax oversight by the FDA.  

Founded in 1981, the Project On Government Oversight (POGO) is an independent nonprofit that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open, and ethical federal government.

Supreme Court Restricts Right to Appeal Under the False Claims Act

FOR IMMEDIATE RELEASE

 

Supreme Court Restricts Right To Appeal Under The False Claims Act

Washington, D.C. June 8, 2009. Today the U.S. Supreme Court issued a decision which “chipped away” at the rights of whistleblowers to use the most important anti-fraud law in the United States, the False Claims Act.   The False Claims Act permits whistleblowers to file claims on behalf of the United States, and force corrupt government contractors to pay back to the government monies improperly obtained from taxpayers.  

The ruling was written by Justice Clarence Thomas in the case of U.S. ex rel. Eisenstein v. City of New York.  The Court applied a 30 day limitations for an appeal of a False Claims Act ruling when the Government declined to intervene in the case.   Generally a 60 day limitations period applies to cases in which the United States is a party, but Justice Thomas decided that if the Government does not formally intervene in the case it should be treated essentially like any other private party claim.  

The Eisenstein appeal was filed within 54 days of the lower court ruling and the harsh result of Justice Thomas’ holding is to dismiss the anti-fraud claim as being untimely.  
 
 The following statement was issued by Stephen Kohn, the President of the
 National Whistleblowers Center:
 
 ”The Supreme Court in Eisenstein has once again chipped away at the ability of whistleblowers to challenge corrupt contracting practices under the False Claims Act.  The ruling demonstrates a fundamental misconception of the purposes behind the False Claims Act, the most important anti-fraud law in the United States.  The Court ruled that FCA cases pursued by whistleblowers are similar to private lawsuits.  This is wrong.  Whistleblowers under the FCA have a powerful right to file cases on behalf of the United States, and the vast majority of any recovery in these cases is paid to the U.S. Treasury — not the whistleblower.  Taxpayers are the main beneficiaries of these cases — the rules concerning filing deadlines should reflect the intent of the law, and should also reflect the fact that the United States, recovers no less then 70% of all monies obtained in an FCA case.  In today’s environment, the Supreme Court should be strengthening anti-fraud laws, not continuously chipping away at the ability of whistleblowers to present their cases.”

***

KBR Sues The United States of America

From Ms. Sparky:

 

Yes, you read that right. KBR has filed suit against The United States of America (the taxpayer). Apparently they got audited over the Tamimi charges for the Camp Anaconda dining facilities (DFAC) and payment was withheld in the amount of $41 million. I have a feeling this is just the first of the KBR lawsuits against the US Government. I suspect every time they get caught violating the contact and funds are withheld, they will sue.If you are on a non KBR computer (they still have me blocked for the most part) and have access to Ms Sparky click HERE to read all about it. I have also downloaded and linked to the complaint filed. If not keep and eye out on the news. I have forwarded the docs to EVERYONE!! Yes, KBR is terminating people. Tensions seem to be running high and tempers are flaring in some camps. Please keep in mind if you assault someone the Iraqi’s take over. So don’t try to take revenge out on your manager. If you want revenge, come home and tell your story to Congress or the countless investigators investigating KBR. Don’t be stupid!! Email me and let me know how terminations are going at your camp. Don’t think for a minute that it won’t be you. Get your stuff packed. They are giving some people only ONE days notice. And, my personal opinion on turning in your CAC card while you are stuck in country is…..I wouldn’t. That is basically your passport/visa for the military bases. That gives you permission to be there, to eat at the DFAC’s and go to the PX. Click HERE for a link to the Senate DPC site to view the entire hearing video, read the statements and view some very interesting supporting documents. The Senate DPC staff did a great job on this hearing! Do you know who these people are from Camp Harper/Camp Adder? Person on the left is possibly a plumber, center is security, right is security.  I know KBR is going to put on the pressure with threats and intimidation. That is their MO. Just be smart! If you have questions you can email me by replying to this Update. Be safe!! Ms Sparky (aka Debbie Crawford)

Senate Subcommittee Hearing on S.372, Whistleblower Protection Enhancement Act of 2009

Dear MISC Members,
 
June 11th, TOMORROW, the Senate Homeland Security and Governmental Affairs Oversight of Government Management Subcommittee will hold a hearing on S. 372, the Whistleblower Protection Enhancement Act of 2009.
 
Time: 2:30pm
 
Location: Dirksen Senate Office Building, Room 342
 
The hearing will consist of the following 5 witnesses–3 of which are whistleblower advocates
 
 
Danielle Brian, POGO
Bill Branford, Senior Executive Association
Rajesh De, Dept. of Justice
Tom Devine, GAP
Robert Vaughn, Professor at AU School of Law
 
 
Please come and support our members as they help build a written record, at the request of Senator Collins (R-ME), to demonstrate why the WPEA of 2009 must include access to jury trials and coverage of all federal employees to be a credible whistleblower law in practice. If you cannot attend in person, live coverage should be available at the following link; http://hsgac. senate.gov/ public/index. cfm?Fuseaction= Hearings. Detail&HearingID=f657db46- 9461-43ba- 99de-2ac25593c89 9 .
 
The Congressional Quarterly wrote the following on the upcoming hearing;
 
Beefed-up protections for federal whistle-blowers, a top priority for many watchdog groups, will be considered Thursday by the Senate Homeland Security and Governmental Affairs Oversight of Government Management Subcommittee. Whistle-blower advocates favor the House’s version of the bill, which specifically insulates national security whistle-blowers and mandates jury trials for cases tangled in the bureaucratic queue, over legislation introduced by Homeland Security and Governmental Affairs ranking member Susan Collins and Oversight of Government Management Subcommittee Chairman Daniel Akaka, D-Hawaii. Rajesh De of the Justice Department’s Office of Legal Counsel will make a repeat appearance on Capitol Hill to present the viewpoint of the administration. But some outside groups privately grumble that the president has yet to make good on a campaign promise to construct the tallest of fences between federal whistle-blowers and their superiors.
 
 

Shanna Devine
Legislative Campaign Coordinator
Government Accountability Project
<?xml:namespace prefix = ns0 ns = “urn:schemas- microsoft- com:office: smarttags” /><?xml:namespace prefix = st1 ns = “urn:schemas- microsoft- com:office: smarttags” />1612 K St NW, Suite 1100
Washington, DC 20006
(202) 457-0034  ext. 132 (voice)
(202) 457-0059 (fax)
Email: shannad@whistleblow er.org
Website: www.whistleblower. org <?xml:namespace prefix = o ns = “urn:schemas- microsoft- com:office: office” />

Rewarding Failure: Contractor Bonuses for Faulty Work in Iraq

Rewarding Failure:
Contractor Bonuses for Faulty Work in Iraq

Wednesday, May 20, 2009
9:30 a.m. to 11:00 a.m.
628 Dirksen Senate Office Building

Senator Robert Casey, Senator Byron Dorgan, Senator Kay Hagan, Senator Amy Klobuchar, Senator Frank Lautenberg, Senator Mark Udall, and Senator Sheldon Whitehouse attending.

 

Opening Statement

Senator Byron L. Dorgan
Chairman, Senate Democratic Policy Committee

Witness Statements

Jim Childs
Master Electrician, former Subject Matter Expert for Task Force SAFE

Eric Peters
Former KBR Master Electrician

Charles Smith
Former Chief of HQ, Army Field Support Command
Field Support Contracting Division

Additional Materials

2007 DCMA Memo on Electrical Hazards Created by KBR

2008 DCMA Letter to KBR on Corrective Action Report

KBR Level III Corrective Action Request

KBR Level III Corrective Action Request (without attachments)

Additional Areas Cited for Poor Performance Under Task Order 139

Electrical Hazards Assessment — Iraq

KBR Electrical Fire Report

KBR Fire Inspection Report

KBR DCMA Citations for Poor Performance in a Variety of Jobs and Multiple Areas (Excel spreadsheet)

 ***********************************************************************

 

Senate Whistleblower Hearing Today! Take Action!     Dear Action Alert Member, The Senate is holding a hearing on the Whistleblower Protection Enhancement Act today.  The public hearing will be held in the Dirksen Senate Office Building, Room 342 at 2:30 PM.  Please attend if you are in the DC area or you can watch live online by clicking here. Now is the time to make your voice heard!  If you have not sent an email to Congress send it now!  Call Senators Daniel Akaka (202) 224-6361 and Susan Collins (202) 224-2523, the Chairman and Ranking Member of the Senate Committee on Homeland Security and Government Affairs, and tell them that all federal employees, including those who report misconduct in national security and defense, must have whistleblower protection with full court access. During the campaign, President Obama pledged to support effective legislation that would protect all federal employees with a guaranteed right to federal court access.  Please urge the Senate to back up this promise. Today is the day to send an action alert.  Today it is imperative to pass this alert on to a friend or co-worker so the Senate can hear form the public while they are debating the scope of the law. Thank you for your continued support. Sincerely, Stephen M. Kohn President National Whistleblowers Center P.S. Once again, please pass this alert on to a friend or co-worker.  Thank you!

You can help whistleblowers…go here.

From: Stephen Buckley <sbuckley@igc. org>
Subject: See WBer idea posted on the WhiteHouse.gov website

Dear Community of Whistleblowers,

I thought you might like to vote “thumbs-up” at the WhiteHouse.gov website for my “Safe Whistleblowing” idea (although I do not call it that).  Feel free to vote for the other ones, too.

Here’s the message (below) that I’m sending out for general distribution.

vr,
Stephen Buckley
http://www.UStransp arency.com
Whistleblower – U.S. Dept. of Energy

———— ——— ——— ——

Dear All,

I humbly ask that you review and vote on my four ideas that I posted on the White House’s brainstorming session on “open government”.  (Note: The website – and voting – will close sometime this Thursday.)

The idea descriptions (below) are the short versions.

And, if you DO like any of them, please forward this email, with an endorsement, as you see fit.

 

1. “MyGov.gov” –> Customized to What Affects YOU

The government should be trying to engage YOU (not vice-versa). For example, an email-notice can reach out and engage you, but an obscure website does not. “MyGov.gov” would let you fill out a profile, so that you will get email-notices ONLY about those things that affect YOU. (This is how USAjobs.gov already works.)

Give that idea a “thumbs-up” here:
http://opengov. ideascale. com/akira/ dtd/2929- 4049

============ ========= ========= ========= ====

2. Make It Safe for Govt. Workers to Innovate to Save Money

I’m a former federal employee who worked at five different agencies, and I know from experience that the only way for to make it safe for government workers to talk about saving money with innovative ideas (or simply pointing out waste) is to have an online system that allows them to raise the idea BUT hides their true identity. (FYI: The existing Inspector-General system does NOT do this.)

Give that idea a “thumbs-up” here:
http://opengov. ideascale. com/akira/ dtd/2481- 4049

============ ========= ========= ========= ===

3. Give Citizens a Simple Checklist for Rating “Public Engagement“

Citizens should have a simple checklist that they can take when they attend a public meeting so that they can rate how “open” the meeting was (i.e., with respect to Transparency, Participation, and Collaboration) .

This simple checklist could be the standard tool for citizens to provide feedback to government agencies about the quality of their public engagement activities. In fact, the requirement for federal department and agencies to “solicit public feedback” about their public engagement is mentioned three (3) times in President Obama’s Memorandum on Transparent and Open Government. (BTW: The League of Women Voters has something similar to this.)

Give that idea a “thumbs-up” here:
http://opengov. ideascale. com/akira/ dtd/2789- 4049

============ ========= ========= ========= ===

4. Let’s Be Clear on the Terminology about “Public Engagement”

We need to better define the terms that we are using in order to have a better discussion about how we achieve Open Government. For example: If a “town-hall meeting” can be a political speech followed by couple questions, then does that qualify as “public engagement” (or is it just a photo-op)?

If we all have different ideas about what is (and is not) “public engagement” or “transparency” or (insert buzzword here), then we will have a very hard time reaching consensus about how to go forward. (This, of course, is one lesson from “The Tower of Babel“).

Give that idea a “thumbs-up” here:
http://opengov. ideascale. com/akira/ dtd/2693- 4049

============ ========= ========= ========= ===

Thank you for taking the time to give this your consideration.

sincerely,

Stephen Buckley
Chatham, Mass.
H/O: 508-945-0518
http://www.UStransp arency.com

P.S.  The language above is taken from my blog.   The direct web-address to that specific posting is:
http://tinyurl. com/p4yueq