4 replies to this topic

[bobdrake12]

http://news.yahoo.co...da_commissioner

Wed, Dec 11, 2002

FDA Says It Will Stop Misleading Drug Ads (excerpts)

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON (AP) - The new chief of the powerful Food and Drug Administration (news - web sites) promised faster action Wednesday to stop drug advertisements that mislead patients into thinking a medication is better or safer than it really is.

Expect more aggressive action against makers of dietary supplements that make unproven health claims, too, said FDA Commissioner Mark McClellan.

But McClellan will have to make a big change, said a consumer advocate who tallied FDA's attempts to stop untruthful drug ads — and found warning letters to the offending manufacturers have dropped by almost two-thirds in the last year alone.

"The bottom line is they're not doing enforcement," said Dr. Sidney Wolfe of the advocacy group Public Citizen. Misleading advertising "can make the difference between someone getting the right drug and the wrong drug. ... It's a health and safety issue."

The FDA is responsible for ensuring that the $2.7 billion worth of drug ads aimed at patients each year are fair and accurate. But critics argue that ads too often make the pills seem a panacea while downplaying side effects. Just last week, congressional investigators said misleading ads often are off the air by the time FDA gets around to chastising their makers.

One reason: A Bush administration policy change this year that required FDA's chief counsel to review every warning letter before it's mailed to drug companies.

So far this year, the FDA has issued only 27 letters ordering drug companies to stop a misleading ad, down from 73 such warnings last year and a high of 157 in 1998, Wolfe said.

This year's policy change "had a chilling effect" on an already weakening regulatatory process, Wolfe said. "If you're one of these companies, you can't help but notice."

McClellan, a physician-economist and longtime adviser to President Bush (news - web sites) on health policy, said drug ads in general can be helpful if they make people aware of treatments for an ailment they've been suffering in silence.

The warning letter review was an attempt to strengthen FDA's legal hand, and while it initially caused delays, the chief counsel hasn't blocked any attempt to stop a misleading ad, McClellan said Wednesday during his first meeting with reporters since becoming commissioner last month.

"Let me be clear," he said. "We are not backing off on our policy of enforcing the law here. ... We will not be afraid to go to court if necessary."

Another problem is repeat offenders. Last week's congressional report cited as an example Pfizer's cholesterol-lowering drug Lipitor (news - web sites). Four times over the last four years, the FDA cited Lipitor ads for giving the wrong impression that it can reduce heart disease and falsely claiming it's safer than competing drugs.

For repeat offenders, "issuing warning letters is not enough," McClellan stressed. "We will not be afraid to go further in cases of recurrent patterns of abuse."

But he wouldn't detail what additional steps FDA might take. Wolfe called the options unclear, saying FDA can't even fine companies over ads.

[bobdrake12]

http://seattlepi.nws.....slug=Drug Ads

Wednesday, December 4, 2002 · Last updated 2:03 p.m. PT

FDA Has Limitations in Policing Drug Ads (excerpts)

By JANELLE CARTER, ASSOCIATED PRESS WRITER


WASHINGTON -- It takes federal regulators so long to approve a letter aimed at stopping misleading drug advertisements that often the ad campaign is over before the drug company receives the letter, a report said Wednesday.

The report by the General Accounting Office, the investigative arm of Congress, detailed some limitations of the Food and Drug Administration's oversight of direct-to-consumer advertising by drug companies, which has tripled since the FDA loosened drug promotion rules in 1997.

Many drug companies promote their products to consumers through ads in magazines and broadcasts on radio and television. The industry spent $2.7 billion on consumer advertising in 2001, the report said.

The FDA is responsible for seeing that the ads are fair and accurate, but the report found a number of problems in getting misleading advertisements removed.

For instance, many pharmaceutical companies have run misleading advertisements for a particular drug again and again. Others did not submit new ads to the FDA in a timely manner for review. Under government regulations, drug companies must submit all ads to the FDA once they are disseminated to the public.

Drug manufacturer Pfizer, for instance, was issued four letters over the last four years about broadcast and print advertisements for its cholesterol-lowering drug Lipitor. The agency said the ads gave the false impression that Lipitor can reduce heart disease and falsely claimed that Lipitor is safer than competing drugs.

[bobdrake12]

http://my.webmd.com/...icle/1691.51295

Misleading Drug Ads Persist (excerpts)

Federal Report Calls for Speedier FDA Review, Action

By Jennifer Warner, WebMD Medical News

Reviewed By Michael Smith, MD

Dec. 4, 2002 -- Pharmaceutical companies continue to deliver misleading drug ads to consumers, according to a new government report. And delays in the FDA's review process and repeated violations by some drug companies are largely to blame, say officials.

According to the report released by the U.S. General Accounting Office (GAO), spending on direct-to-consumer advertising of prescription medicines has tripled in recent years. And prescription drug spending is the fastest growing component of healthcare spending.

Under current government regulations, pharmaceutical companies are required to submit all drug ads to the FDA when they are first released to the public. If the FDA finds the advertisement to be misleading or otherwise fails to fairly represent both the benefits and risks of the advertised drug, it may issue a regulatory letter requesting that the company either withdraw or revise the ad or a warning letter for more serious violations.

The FDA issued 88 regulatory letters and four warning letters between August 1997 and August 2002 for advertisements that violated its standards. FDA officials told GAO researchers that companies that received these letters have invariably stopped the misleading advertisement.

But the report found that a letter from the FDA isn't always enough to make pharmaceutical companies change their ways.

In fact, between 1997 and 2002 the report says the "FDA has issued repeated regulatory letters to several pharmaceutical companies, including 14 to GlaxoSmithKline, six to Schering Corporation and five to Merck & Co." Some companies have received multiple letters for new ads with misleading claims about the same drug.

"For example," the report states, "FDA issued four separate regulatory letters, one of which was a warning letter, to stop misleading advertisements for the allergy drug Flonase marketed by Glaxo Wellcome in 1999 and 2000." The letters cited a lack of balance, unsubstantiated claims about efficacy, and failure to provide risk information about major side effects.

[bobdrake12]

http://www.roanoke.c...tory141028.html




Sunday, December 08, 2002

Remove deception from drug advertisements (excerpts)


Congress should check the Bush administration's effort to obstruct enforcement of fairness and accuracy in marketing.


HEALTH CARE policymakers advise Americans to be self-educated consumers - active partners, with their doctors, in preventing and treating illnesses. Such advice is hollow when drug manufacturers can hoodwink the public with near impunity.

Drugmakers can, too easily. And they do, too frequently, thanks to bureaucratic roadblocks that the Bush administration has thrown in the path of Food and Drug Administration regulators.

The process should be streamlined, even if it takes an act of Congress. And it might.

Federal investigators told lawmakers last week that procedural changes ordered by Bush's Department of Health and Human Services delay FDA enforcement of federal standards that are supposed to ensure the accuracy and fairness of ads for prescription drugs.

The delays amount, at worst, to only two or three months, according to the study by the General Accounting Office. But even a few weeks is time enough to allow deceptive ads to reach a receptive public. Advertisements frequently run only a month or two anyway.

And they can be just what the doctor ordered - for the health of drug industry profits, if not always the health of patients.

Reassuringly, investigators found that - contrary to the assertions of industry critics - drugmakers do not spend more on advertising than on research and development. But they do spend huge sums: close to $20 billion on promoting their products, $2.7 billion of which is spent on direct pitches to consumers, compared to about $30 billion on developing new drugs.

Spending on consumer advertising has risen about 150 percent since the FDA eased restrictions in 1997. And all that spending has had an effect.

[Mind]

Direct to consumer drug ads losing their appeal.

Could be another blow to traditional media outlets if Drug companies stop advertising. Amazing that with all the drug commercials on the air, only 3.5% of patients ever ask for the brand name drugs and apparently the rate was never over 10%. I mostly ignore the ads, but I don't see a big problem with it.