Janet's Conner

This Blog tell the Truth and will never not tell the Truth. Impeach Bush

Saturday, May 20, 2006

BUSH USES FDA TO SHIELD BIG PHARMA FROM LAWSUITS---PART I...................


In January 2006, the FDA announced the Bush administration's latest gift to Big Pharma in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.

"We think that if your company complies with the FDA procesess, if you bring forward the benefits and risks of your drugs, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.

To soften the blow, the agency's claim of federal preemption was included as a preamble to the long sought after new drug labeling guidelines. In response to the FDA's statement, Senator Edward Kennedy (D-MA) issued a statement of his own that said: "It's a typical abuse by the Bush Administration---take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."

The plot was already recognized by state lawmakers and trial lawyers as another ploy to reduce the public's ability to hold Big Pharma accountable. "Eliminating the rights of individuals to hold negligent companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America,

"The fact that the drug industry can get the FDA to rewrite the rules so that CEO's can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much contol these big corporations have over our political process," Mr. Suggs told the Washington Post.

According to Attorney Mark Labaton, a partner at the firm Kreindler & Kreindler, LLP, with offices in New York and LA, 'the Administration's recent efforts to misuse federal rulemaking in the pharmaceutical and other areas to eviserate consumer rights is a big step backward."

"The new FDA rules to limit consumers' rights," he says, "are part and parcel of a larger effort to deny persons injured by unsafe products---be they drugs, cigarettes or automobiles--- any form of redress."

"Clearly," Mr. Labaton notes, "this Administrtion and its supporters want to slam the courthouse doors on working men and women injured by unsafe products."

He says it's ironic the "an Administrative that calls itself "compassionate" and "conservative" consistently turns its back on "limited government" and "state's rights" when it comes to protecting the rights of seriously injured consumers."

Upon learning of the FDA's power grab, the National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have. The organization bases its opposition, in part on the following:

"FDA has usurped the authority of Congress, state legislatures and state courts. There is no statutory authority in the FDCA for FDA to preempt state product liability laws as they relate to prescription drugs.

"Instead of seeking valid congressional authority, unelected agency officials are seeking to preempt state product liability laws by writing this preemption into a final rule, thereby undermining state policy and judicial decision made in this area.

"State tort laws and civil justice systems serve as an important check on federal standards. Our civil justice system establishes a duty of care that protects citizens when the federal government is too slow to act or when federal standards are insufficient. States have the ability to achieve greater protections for their citizens through successful product liability lawsuits."

In an earlier gift delivered to Big Pharma in December 2005, Republicans leaders, and specifically Senator Bill Frist (R-TN), attached protective provisions to a Department of Defense appropriations report that gave the industry "unprecedented immunity," according to Democratic lawmakers who described the underhanded move as follows:

"Republican leaders added provisions to the conference report after cutting a back-room deal in the middle of the night. The conference report grants sweeping immunity to drug companies for injuries caused by vaccines and drugs and for the administration of those vaccine and drugs, even if they are made with flarant disregard for basic safety precautions.

"Moreover, the compensation program is a sham, leaving people who become injured from a drug or vaccine without recourse."

Since 2002, Senator Frist had tried numerous times to insert this rider in Homeland Security Bills after thousands of lawsuits were filed by parents who believe the mercury-based preservative thimerosal, contained in childhood vaccines until recently, caused autism and other neurologocal disorders in their kids.

The rider could save Big Pharma hundreds of millions, if not billions of dollars.


The latest revelation of this little stunt came on May 8, 2006 when the Tennessean reported that vaccine industy officials helped shape legislation behind the scenes that Frist secretly amended into a bill, according to e-mails obtained by Public Citizen, a public advocacy group.

The industry group, called the Biotechnology Industry Organization, wanted the vaccine liability language in the bill, the e-mails proves

"At Senator Frist's staff's request, this morning, BIO (Tom and I) participated in a meeting with three other industry represntatives (Sanofi and an outside counsel who works for both Pfizer and Roche, I believe), administration staff (HHS, DoJ and WH Leg Affairs), and Liz Hall to further discuss liability," BIO official Dave Boyer wrote in a November e-mail obtained by Public Citizen.

Other E-mails and documents show that BIO met privately with Frist's staff and the White House to figure out ways to give drug makers protection from people injured by vaccines.

"The lack of any restriction on jury trial is problematic," the BIO analysis said. "Where injured parties have no further avenue for relief, juries are likely to find ways to award damages."

In another e-mail, Boyer described a meeting in which Karl Rove said it was "important to the President that a bill move this year," and said "they have invited industry to discuss what they understood to be a few key remaining points" of contention.

Republican members of Congress had tried to on several occasions to enact similar legislation of its own, but with voters already so angry over soaring drug costs, they finally had to back off.

With less than 3 years left in office, and the Democrats positioned to take over Congress in the fall elections, Bush had to find a way to repay Big Pharma so he came up with the bright idea to utilize the FDA and kill 2 birds with one stone.

This route would spare Republicans the task of trying to pass pro-industry legislation in an election year and still reward Big Pharma for the more than $80M that Republicans received from drug makers over the past decade.

Since 2000, the top drug corporations, their trade group, and their employees gave more than $10M to 527 organizations, tax-exempt political committees which operate in the grey area between federal and state campaign finance laws, according to Drug Lobby Second to None, July 7, 2005, M. Asif Ismail.

Nearly $87M of the contributions went to federal politicians, with almost 69% going to the Republicans. Top recipients include Bush, with upwards of $1.5M, and members who sit on committees that have jurisdiction over pharmaceutical issues, reports Drug Lobby Second to None.

During Bush's campaign's, 21 pharmaceutical industry executives and lobbyists achieved "Ranger" or "Pioneer" status, which means they raised at least $200,000 or $100,000, respectively, during the 2000 and 2004 campaigns.

According to Public Citizen, the group included 5 executives from brand-name drug companies, 6 officials from HMO's, the CEO of a pharmacy services company that runs a PBM, the head of a direct-mail pharmacy, and 8 Washington lobbyists who represent drug companies and HMO's.

Frist is never shy when it comes to calling in markers from drug companies. In November 2004, when he wanted to take a victory tour celebrating the newly elected Republican senators, "A Gulfstream corporate jet owned by drug maker Schering-Plough was ready to zip the Senate majority leader to stops in Florida, Georgia and the Carolinas," according to the April 25, 2005 USA Today.

Frist's PAC reimbursed Schering $10,809, the equivlent of a commercial first-class fare, but that was only a fraction of the cost of a charter flight, which would have cost 3 times that much. Besides, the cost was almost a wash because Schering had donated $10,000 to Frist's committee in 2003-04, according to USA Today.

It was worth pointing out that Big Pharma was the largest contributor to the National Republican Senatorial Campaign Committee while Frist chaired the Committee.

The ever-growing number of lawsuits in state courts has created a nagging fear in drug makers. Local juries and elected judges in state courts are much more likely to go against drug giants than juries and appointed judges in federal courts which is a one of the main reasons why Big Pharma wants all cases moved to federal courts.

End of Part I...............................................


Source: OpEdNEWS
Story By: Evelyn Pringle
May 13, 2006

*Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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