Senator Grassley & FDA


 

Senator Grassley: http://grassley.senate.gov/webform.htm

The Government Accountability Project (http://www.whistleblower.org/template/index.cfm) which is assisting Dr. Hampshire legally accepts earmarked contributions through The Network for Good (http://www.networkforgood.org/donate/)

November 19, 2006 - Iowa senator a champion of whistle-blowers
Sen. Charles Grassley has become Congress’s expert on using whistle-blowers to ferret out waste and fraud.

October 31, 2006 - Grassley Continues to Press FDA on Handling of Hampshire Case

September 20, 2006 - Grassley outlines problems at FDA, urges reforms

June 15, 2006 Washington Post - Senator’s HHS Trip for Antibiotic Data Yields Only Ire

"...... “I’m tired of the runaround,” he said after leaving the HHS headquarters. He said that he told the agencies’ officials that “I know it’s probably not your intent to protect companies, to cover for companies.”

“But I said that every time that you stand in the way of information getting out that ought to be public, that’s the impression you give the American people.”

June 14, 2006 - Remarks of U.S. Sen. Chuck Grassley of Iowa at the U.S. Department of Health and Human Services

"I’m fed up with resistance from the bureaucracy. It’s been one excuse after another. Practices and policies have changed from one day to the next. Files available one day become “confidential” overnight. A line agent isn’t allowed to tell his story, even though line agents have been made available in other cases. The agency says its employees will not be prohibited from cooperating with Congress, then instructs its employees not to cooperate with Congress.
The agency won’t provide a background briefing on past regulatory decisions."

 

2006 --- GAP Creates Drug Fact Squad!

"According to polls, Americans no longer trust the pharmaceutical industry. Simultaneously, there is a crisis of confidence in the Food & Drug Administration (FDA) as an impartial arbiter of drug safety and effectiveness. More than half of the agency’s drug budget comes from industry user fees earmarked for speeding up the approval of drugs. As a result, the FDA, long established as the “gold standard” of consumer protection against industry’s dangerous drugs, now treats the industry as its primary client.

If we, the public, can’t rely on either industry or the FDA to tell it to us straight, then where can we turn for independent and reliable information about prescription drugs?"

 

Summer 2006 GAP "Bridging the Gap" newletter (page 4) Spotlight: A Conversation with GAP President Louis Clark and Victoria Hampshire

"GAP client Dr. Victoria Hampshire was a safety officer at the Food and Drug Administration’s Center for Veterinary Medicine (CVM) charged with reviewing the safety of a dog care product manufactured by Fort Dodge, a Wyeth subsidiary. She concluded that ProHeart 6 was not safe and may have contributed to some 500 dog deaths. Wyeth hired a private investigator to mischaracterize information about her, and was granted a private session with then-acting FDA Commissioner Lester Crawford – after which she was removed from review of the product. The FDA then launched a criminal investigation of her. Dr. Hampshire was totally exonerated and now Senator Grassley is investigating Wyeth and drug company efforts to target FDA safety officers whose findings disagree with their corporate plan."

 

May 16, 2006 Senator Says FDA Should Stop Citing a Fraudulent Ketek Study, Seeks Access to Information

"Sen. Chuck Grassley said it’s “mystifying” that the Food and Drug
Administration continues to provide information the agency knows is fraudulent about the safety of the antibiotic Ketek, and he’s keeping the pressure on for more information about the FDA’s initial approval and post-market surveillance of the drug."

 

May 1, 2006 Sen. Grassley Slams FDA for Citing Fraudulent Safety Study

"Sen. Chuck Grassley today released information about his ongoing
investigation of the Food and Drug Administration regarding the drug-safety agency’s initial approval and post-market surveillance of the antibiotic Ketek".

 
April 24, 2006 Senator Grassley’s Comments on the New GAO Report on the FDA and Post-market Drug Safety
 

Spring 2006 GAP "Bridging the Gap" newletter GAP Client Blows Whistle on Dangerous Dog Drug- Saving Our Pets

"FDA Veterinarian Dr. Victoria Hampshire found a big problem with a canine heartworm drug in 2004 – it was related to the deaths of over 500 patients. She recommended that the drug be immediately recalled from the market. Unfortunately for her, the profitable drug’s producer, Wyeth Pharmaceuticals, tried to counter Dr. Hampshire’s claim by attacking her character.
What followed is a twisted story about a secret FDA/drug-company meeting, a smear campaign, and an unjustified criminal investigation. Luckily for Dr. Hampshire, she found support and allies in GAP and a key U.S. Senator. In this edition’s Food & Drug Safety update, read the chilling story of a major pharmaceutical corporation’s underhanded campaign to discredit Dr. Hampshire and how the FDA initially caved under corporate pressure. Story on page 3."

 

March 3, 2006 Grassley Urges More Teeth for FDA’s Post-market Drug Enforcement

“The FDA lacks the ability to effectively police drugs on the post-market side. The agency really needs more enforcement tools. The bill Sen. Dodd and I introduced to establish an independent office of drug safety at the agency will do just that. Companies that don’t comply with their postmarket commitments would face civil monetary penalties. Right now, the FDA has no teeth to enforce post-market drug safety studies. That has to change.”

 

March 2006: Drug Safety: Improvement needed in FDA's Postmarket Decision-making and Oversight Process

" What GAO Recommends
To improve the decision-making process for postmarket drug safety, GAO suggests that the Congress consider expanding FDA’s authority to require drug sponsors to conduct postmarket studies when needed. GAO also recommends that FDA systematically track postmarket drug safety issues, revise and implement its draft policy on major postmarket safety decisions, improve the dispute resolution process, and clarify ODS’s role in scientific advisory committees. In its comments on a draft of this report, FDA stated that GAO’s conclusions were reasonable. FDA did not comment on GAO’s recommendations."

 
February 1, 2006 - DVM Mag: Wyeth to comply with Senate investigation
 

February 2006 REVIEW OF THE FDA’S APPROVAL PROCESS FOR THE VAGUS NERVE STIMULATION THERAPYSYSTEM FOR TREATMENT-RESISTANT DEPRESSION

"As part of that mission, the FDA weighs the risks and benefits of a product, in this case a medical device, to determine if the productis reasonably safe and effective for use."

 
Topeka (KS) Drug company harasses honest regulator
 

GAP 12/20/05 -- U.N. Issues Groundbreaking Whistleblower Policy

"Washington, D.C. – The Government Accountability Project (GAP) praised the United Nations for issuing a new standard of whistleblower protection in an anti-retaliation policy released today as a Secretary General’s Bulletin. GAP, which was consulted directly regarding the policy, is hailing the protections as the benchmark for other Intergovernmental Organizations (IGOs). The new protections take effect on January 1, 2006. While these breakthroughs set the bar higher for whistleblower protection for all IGOs, the group cautioned that they must be viewed in the larger context of unfinished structural reform that awaits U.N. General Assembly action next year."

 

GAP 12/7/05 -- GAP Creates Drug 'Fact Squad'

"According to polls, Americans no longer trust the pharmaceutical industry. Simultaneously, there is a crisis of confidence in the Food & Drug Administration (FDA) as an impartial arbiter of drug safety and effectiveness. More than half of the agency’s drug budget comes from industry user fees earmarked for speeding up the approval of drugs. As a result, the FDA, long established as the “gold standard” of consumer protection against industry’s dangerous drugs, now treats the industry as its primary client."

 
Pharma Watch 12/7/05 -- Wyeth Witch hunt: $32 million vs $196
 

Medical and Science News 12/6/05 -- US FDA vet says agency probe harmed review process

"A U.S. Food and Drug Administration probe of a veterinarian studying the risks of a Wyeth heartworm drug has had a "chilling effect" on fellow government scientists and harmed their ability to protect the public, the researcher said on Monday."

 

Boston Globe 12/6/05 -- Dog-drug case renews scrutiny on FDA-- Agency transferred reviewer after Wyeth unit questioned her

"After a Food and Drug Administration reviewer alerted managers to a surge in safety problems with a veterinary drug, supervisors transferred her from the case and the agency began secretly to investigate her."

 

NYTimes 12/6/05 -- F.D.A. Official Chides Agency Over Treatment

"A federal drug safety official said that her career had been sidetracked after complaints from a drug maker led the F.D.A. to suspend her from reviewing a heartworm medicine for dogs."

 

NJ.com 12/6/05 -- Regulator opposed drug and Wyeth opposed her

" Last January, Victoria Hampshire was unexpectedly reassigned from her job at the Food and Drug Administration, where she was a safety officer overseeing veterinary medicines."

 

USA Today 12/5/05 -- Staffer's move sparks probe of FDA, Wyeth

"A Food and Drug Administration scientist said Monday that she was reassigned and, without her knowledge, subjected to a criminal investigation by the agency because of allegations brought by Wyeth (WYE), maker of a lucrative heartworm shot pulled off the market last year as a result of her work."

 

U.S. Senate/Fiance Committee 11/ 29/ 2005 -- Grassley seeks correction from the Food and Drug Administration

"Sen. Chuck Grassley is calling on the Food and Drug Administration
to correct its statement of last week that the agency conducted an investigation of one of its own scientists with her knowledge despite evidence to the contrary."

 
PharmaWatch Blog 11/24/05 -- Smears and censorship: Wyeth has gone to the dogs
 

FDANews 11/21/05 -- Grassley Uses Alleged Wyeth Dispute to Call for Change in FDA Leadership

"Sen. Chuck Grassley (R-Iowa), chairman of the Finance Committee and an increasingly vocal critic of the FDA, is using an alleged effort by Wyeth to discredit an agency investigator as ammunition in his campaign to reform the agency's relationship with the pharmaceutical industry and to bolster his call for a permanent, reform-minded commissioner."

 

ScienceDaily 11/18/05 -- Grassley renews calls for FDA reform

"Problems exist not only within the Center for drugs, but extend to the Centers for devices, biologics and even to veterinary medicines," Grassley, R-Iowa, said in remarks delivered on the Senate floor late Thursday.

"I am concerned and every other member of this Senate should also be concerned," he said."

 
GAP: 11/18/05 -- Senator Grassley Investigates charges of FDA and Wyeth misconduct

"Yesterday on the Senate floor, Senate Fiance Committee Chairman Charles Grassley (R-Iowa) announced that he is investigating charges that Wyeth Pharmaceuticals smeared an FDA safety officer who negatively reviewed one of Wyeth's animal care products, and that the FDA subsequently removed her from that product's review. Dr. Victoria Hampshire , the safety officer, "concluded that Wyeth's drug (Proheart6) was killing hundreds of dogs," according to Sen. Grassley. Dr. Hampshire is represented by the GAP."

Click here to read Sen. Grassley's floor speech

Click here to read Sen. Grassley's letter to Wyeth

Click here to read letter sent to FDA's Dr. Sundlof from veterinarian

 

ABC News 11/17/05 -- Senator says Wyeth targeted FDA reviewer

(same article can be found at: http://www.fen-phen-eresource.com/dog.cfm)

"Drug maker Wyeth tried to discredit a Food and Drug Administration scientist who linked the company's withdrawn heartworm treatment to the deaths of hundreds of dogs, a U.S. Republican senator charged on Thursday."

 

GAP: 11/17/05 -- GAP Praises new MDB Whistleblower Policies

"The Government Accountability Project (GAP) today praised breakthroughs in whistleblower protection included as part of greater accountability and transparency standards signed into law Monday, November 14."

 

GAP: 9/29/2005 --GAP Coalition Praises Committee's Decision to Strengthen Whistleblower Rights

"In a letter to House Government Reform Committee Chair Tom Davis (R.-Va.), a coalition of 20 good-government organizations from across the partisan and ideological spectrum praised his committee for a vote scheduled today to give jury trial rights to government whistleblowers. The bill, H.R. 1317, would amend the Whistleblower Protection Act (WPA) to give federal government workers access to courts, akin to the free speech breakthrough for corporate whistleblowers in the 2002 Sarbanes-Oxley Act. UPDATE: The bill passed through committee, 34-1."

 

PRNewswire 8/4/05 -- FDA Ignores its Whistleblowers, New Report Says

"For over two weeks, the news service has been publishing the whistleblowers' allegations that an FDA computer containing trade secret data was lent by an FDA device review manager to an outside candidate for a division director vacancy. The candidate allegedly used the laptop to promote his candidacy in front of an internal employee panel, who complained about the secrets' exposure, according to the whistleblowers."

 

AHRP 6/8/05 -- Grassley Pushes FDA: Transparency, Accountability & Independence / Whistleblowers are essential Witnesses

"WASHINGTON - Sen. Chuck Grassley is questioning the make-up of the new drug and safety board set up by the Food and Drug Administration to provide independent review of FDA-approved medicines.

In a letter sent to the acting commissioner of the nation's drug safety agency, Grassley asked for assurances that the board could act in an unbiased way given its composition and said the deliberations of the panel should be more transparent in order to improve accountability at the Food and Drug Administration."

 

GAP: 6/6/05 -- Watching the Office of Special Counsel

"The Office of Special Counsel (OSC) is the government agency in charge of protecting whistleblowers working within the federal government. Scott Bloch, the current Special Counsel, has come under heavy scrutiny by GAP and other watchdog groups regarding disturbing allegations of purging the OSC of internal critics and arbitrarily dismissing personnel complaints to reduce heavy backlogs. He has also refused to protect workers fired or harassed due to sexual orientation, reversing a long standing OSC practice. Find out about steps GAP has taken to raise awareness of this issue by clicking on our Office of Special Counsel page."

 
Medical community blames Dr. David Graham for warning about prescription drugs; medical McCarthyism now in full swing
 

GAP 5/31/05 -- Medical Whistleblowers Speak out

"..... One of the lessons, says Lenzer, is that "ties between drug regulators and industry may influence new drug approval." Graham said at the roundtable that the FDA was in "a collaborative relationship" with industry, and that the FDA gets money from drug companies through the Prescription Drug User Fee Act "to approve new drugs and approve them more quickly." A senior official at the FDA, said Graham, had told him, "industry is our client."

"The pharma-FDA complex has to be dismantled," he said, "and the American people have to insist on that, otherwise we're going to have disasters like Vioxx that happen in the future."