FDA Plan Would Aid Drug Makers in Liability Suits

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FDA Plan Would Aid Drug Makers in Liability Suits

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

Consumers beware!

FDA politicial appointees have embarked on a plan to divest the

American consumer of the right to seek compensation for defective

prescription drugs.

The Wall Street Journal reports that the agency's plan for revamping

drug labeling rules would carve in stone the agency's former chief

counsel, Troy''s pre-emption argument.

The pre-emption argument holds that the authority of the FDA (and

other federal regulatory agencies) pre-empts any state consumer

protection laws.

In the case of drugs companies like Merck would be free from

liability even as the body count from its pain killer, Vioxx, reaches

tens of thounsands.

The White House, pharmaceutical giants, lobbyists and sycophants are

attempting to frame the argument in terms " tort reform " falsely

creating the impression that the only ones who would lose would be

plaintff attorneys.

In truth, the FDA, whose legal mandate is to protect the public from

drugs that have not been scientifically proven safe and effective, is

proposing a rule to protect the manufacturers of hazardous drugs

instead.

Indeed, FDA's plan would encourage Big Pharma to continue to use

corrupt marketing practices--including flooding the airwaves with

misleading advertisemtns for prescription drugs-- instead of

enforcing truth in advertising laws.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://online.wsj.com/public/article/SB113720623594046758-

2WU_h2bweo8Wdurc2Sbuca_2_yw_20070114.html?mod=tff_main_tff_top

THE WALL STREET JOURNAL

FDA Plan Would Aid Drug Makers in Liability Suits

Agency's Approved Labels Would Pre-empt State Law; Plaintiffs'

Lawyers Object

By ANNA WILDE MATHEWS

January 14, 2006; Page A1

The Food and Drug Administration is preparing to declare that

federally approved medication labels pre-empt state law, a move that

could strengthen pharmaceutical makers' defenses against lawsuits

claiming injury by the companies' products.

The policy could help companies argue they weren't required to warn

consumers about a potential risk when the FDA had determined that the

safety issue didn't warrant inclusion on a medicine's label. The new

policy, which would address state liability statutes, has been

written into a broad new drug-labeling rule that is likely to be

issued shortly, according to people with knowledge of the matter,

though the rule has been repeatedly delayed.

Product-liability suits have become a huge problem for drug makers.

In one of the more high-profile cases lately, Merck & Co. faces

dozens of lawsuits across the country over its withdrawn painkiller

Vioxx. Merck pulled that hugely popular drug from the market in 2004

following a study that linked the drug to an increased risk of heart

attacks and strokes in patients taking it for 18 months or longer.

Merck and other companies have often struggled to explain the

scientific nuances of their drug-safety defenses to juries. As yet,

it isn't clear whether the new FDA policy would affect the Merck

cases.

Kent Jarrell, a spokesperson for Merck, said, " We really can't get

into discussing language of a proposed rule that we have not seen. " A

spokesman for drug maker Pfizer Inc. declined to comment.

Plaintiffs' lawyers, however, oppose the policy. " If the proposed

changes were to be enacted, drug-product safety in the U.S. would

suffer a major setback at a time when the conduct of pharmaceutical

companies and the FDA have been called into question, " said R.

Kline, a plaintiffs' attorney with Kline & Specter and a key player

in Vioxx litigation.

The controversial policy has been written into the preamble of an

important FDA rule that is supposed to reform how drugs are labeled,

according to people with knowledge of the matter. It could still be

toned down or even removed before the rule becomes public, though it

has already survived years of internal debate. The FDA has asserted

similar arguments in briefs filed in legal cases, but the federal

rule would be broader and likely have more impact on individual

judges' decisions. Courts may still choose to reject the reasoning,

however.

The policy would mesh with the White House's focus on tort reform.

Indeed, other federal agencies have made similar moves toward helping

to shield businesses from certain forms of legal action. The National

Highway Traffic Safety Administration last August proposed a new rule

on car-roof strength that would grant legal protection to car makers

that adhere to the safety standard. The U.S. Office of the

Comptroller of the Currency issued a sweeping regulation in early

2004 that said federal banking laws take precedence over a number of

state consumer-protection statutes when applied to national banks.

The agency challenged an investigation of potentially discriminatory

lending practices by New York Attorney General Elliot Spitzer,

arguing that his probe impinged on federal enforcement turf.

Inclusion of the new FDA policy in the long-awaited drug-labeling

rule has sparked disagreements between FDA career officials and Bush

administration appointees, according to people with knowledge of the

matter. Some FDA career staffers have argued internally that it isn't

relevant to the rule's focus on drug-labeling reform, and may draw

controversy to an important regulatory improvement that isn't itself

politically divisive. In addition, career officials believe debate

over the matter has helped delay the labeling change from taking

effect.

The new rule is expected to specify circumstances under which the

legal shield would apply, though it may not limit the protections

solely to those situations, according to people with knowledge of the

matter. The drug company must have provided all its data to the FDA,

these people said.

The drug-labeling rule's language pertaining to the new policy is

likely to contribute to the growing clash over the proper bounds of

state and federal regulatory authority. Big companies have long

fought patchworks of laws that differ from state to state, and

federal efforts to assert authority in various regulatory areas have

drawn testy responses from state officials.

In the case of the new FDA rule, states argue that they weren't

adequately informed that it was coming. Yesterday, the National

Conference of State Legislatures protested the move in a letter to

Health and Human Services Secretary Leavitt, calling it

a " thinly-veiled attempt on the part of FDA to confer upon itself

authority it does not have by statute " and an " abuse of agency

process. "

Past FDA briefs arguing that agency guidelines pre-empt state law

haven't always been accepted by courts. Last July, a federal judge in

Minnesota turned down a Pfizer request to bar a suit over the

antidepressant Zoloft, writing that " federal labeling laws are

minimum standards; they do not necessarily shield manufacturers from

state law liability. ... state-law protections reinforce and enhance "

federal efforts to protect the public.

Defenders of the FDA's pre-emption briefs have argued that they

simply articulate a stance that is implicit in federal law. If state

lawmakers and courts can second-guess the FDA, some drug-industry

officials say, it could lead to a morass of conflicting rules and

undermine the decisions of the government's most qualified

experts. " You want the FDA to have the last word if you believe in

the FDA's expertise, " said Troy, the former FDA chief counsel

who filed several of the briefs and who represents industry clients

in private practice.

The new drug-labeling rule, a major regulation that has been in

development for years, will update the format of the FDA-approved

documents that provide the definitive account of each medicine's uses

and risks. They can stretch for dozens of pages, and even doctors

often find them difficult to navigate. The new layout is expected to

clarify the most important information at the top of the label in a

standardized " facts box " format. It is the centerpiece of a broader

FDA initiative to make drug information more accessible.

-- Won Tesoriero and Barbara ez contributed to this

article.

Write to Wilde Mathews at anna.mathews@...

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