FDA’s Drug Label Rule Fails to Guarantee Access to Vital Information and Include

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http://www.publiccitizen.org/pressroom/release.cfm?ID=2114

 

Jan. 18, 2006

 

 

 

FDA's Drug Label Rule Fails to Guarantee Access to Vital Information

and Includes `Sneak Attack' on Patients' Legal Rights

 

Bush Administration Abuses Executive Powers in Attempt to Override

State Liability Laws

 

 

 

 

WASHINGTON, D.C. – The U.S. Food and Drug Administration, though it

has improved a drug labeling regulation through revisions announced

today, continues to ignore the fact that its rule will not guarantee

patients the most accurate, up-to-date information about their

medications, Public Citizen said today.

 

Further, in an end-run around Congress, the FDA has added to the rule

a preamble designed to preempt lawsuits filed by patients under state

law, potentially leaving victims of FDA-approved drugs with no remedy

for any harm caused by the approved drug.

 

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,

said revisions in the final version of the rule released today will

simplify and prioritize the labeling information that doctors receive.

But the vast majority of patients will not get that information unless

they specifically request it. Instead, they commonly receive patient

information leaflets (PILs) that are commercially produced but whose

content is not scrutinized by the FDA.

 

The FDA's own study has shown that the content of unregulated leaflets

gets a failing grade (average 50 out of 100) in conveying the most

important information to patients, Wolfe said. The agency has the

authority to require agency-approved " medication guides " for each new

prescription and refill but has done so for only about 75 drugs.

 

" It is time to end the double standard where doctors and other health

professionals are informed by FDA-approved labeling, but patients are

treated like second-class citizens, receiving whatever the

out-of-control purveyors of patient information leaflets choose to

dispense, " Wolfe said. " This is a dangerous situation, made worse by

the FDA's poor record of approving harmful drugs based on limited, and

even fraudulent, clinical trials performed by the drug companies. "

 

In a further blow to consumers, the final rule now contains a preamble

aimed at preempting the rights of patients to sue drug manufacturers

if a drug is approved by the FDA. The Bush administration has

previously failed to persuade Congress and, with a few exceptions, the

courts (where it has filed amicus briefs) to shield drug makers from

liability. The new tactic of writing preemption language into federal

regulation notices is an attempt to bypass Congress and override

consumer protection liability laws, said Public Citizen President Joan

Claybrook. The administration has also used such language in recently

proposed automobile safety rules.

 

" This is a sneak attack on consumer rights, " Claybrook said.

" President Bush is once again abusing his executive powers, this time

in his attempt to protect the big pharmaceutical companies from the

consequences of their actions. Thousands of people in this country

have died or been seriously injured by drugs approved by the FDA, and

this administration is saying it doesn't think people should have any

recourse. "

 

It remains unclear what impact the language will have on liability cases.

 

" Ultimately, we are confident that the courts will not defer to the

FDA's opinion on preemption, which is not based on any authority given

to the FDA by Congress, " said Brian Wolfman, director of the Public

Citizen Litigation Group and an expert on preemption law. " In the

meantime, however, the drug companies will be emboldened by this

preemption statement, and use it to complicate injury cases and deter

victims from seeking justice in the courts. "

 

Drug labeling has been a problem for decades.

 

In 1981, the Reagan administration cancelled a proposed regulation

requiring FDA-approved leaflets to be dispensed with prescriptions

just before the rule was to go into effect. The abrupt reversal came

at the behest of drug companies, pharmacy organizations and some

physician groups. Private sector-designed leaflets, not approved by

the FDA, thereby continued to be the norm.

 

Several years ago, shortly after Dr. Mark B. McClellan became FDA

commissioner, he listed as one of his top five priorities helping

consumers obtain truthful information about products they use so they

can make informed decisions. The FDA could go a long way toward

achieving this priority by immediately moving forward with a

long-overdue initiative to require the mandatory distribution of

FDA-approved written drug information with each new and refill

prescription, Wolfe said.

 

In a study conducted several years ago by the University of Wisconsin

for the FDA, although 89 percent of consumers were receiving some sort

of information(unregulated PILs) when a prescription was filled, none

of the approximately 1,300 leaflets studied for four common drugs

achieved minimum goals for useful, scientifically accurate drug

information. As measured by eight objective criteria, the overall

usefulness of information was about 50 percent. According to the

authors, " a majority of leaflets did not include adequate information

about contraindications, precautions, and how to avoid harm. "

 

" The notion that consumer drug information can be 50 percent useful is

unfathomable, " Wolfe said. " Drug information that communicates only

half of what it should is misleading, and misleading drug information

is potentially dangerous. "

 

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