[NVIC] FDA Plan To Shield Big Pharma

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

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BL Fisher Note:

Incrementally, federal health officials, in collusion with pharmaceutical

companies they are supposed to be regulating, are taking away what little

remains of judicial oversight on the drug and vaccine industry. " No

liability, no mandates " will be the mantra of the educated health care

consumer when it comes to vaccines and " Buyer beware " will be the mantra of

those considering drug therapy. Consumers may eventually come to the

conclusion that it is safer to " Just Say No " than take the risk of using

drugs and vaccines which are not subject to judicial review.

http://online.wsj.com/article/SB113720623594046758.html?mod=rss_whats_news_u

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WSJ

January 14, 2006; Page A1

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

Staff Reporter of THE WALL STREET JOURNAL

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across the country over its withdrawn painkiller Vioxx.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.

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