invincible summers

in the middle of winter I at last discovered that there was in me an invincible summer. (albert camus)

The FDA on drug ads April 20, 2009

Filed under: big pharma,FDA — clementine @ 5:42 pm
Tags: , ,

This story at the NY Times just infuriates me. The FDA should not be warning Big Pharma that their online ads must start including risk information about each drug. This is ridiculous. The solution is much simpler: BAN THE ADS COMPLETELY.

A quick note to the FDA: Wake up! Whose side are you on? The patients or Big Pharma? I think we know the answer.

WHEN the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.

Just how the companies were supposed to comply was not so clear. In the 95 characters that Google allowed for search ads, there was no way to include all the required information, the companies argued.

Now, as the companies change their search ads to comply with the letters, industry executives say the solution is worse than the problem: their ads are even more confusing and misleading now, they say. And they worry that regulators will enforce standards that were created for magazines and television, rather than making new rules that acknowledge how Internet ads have evolved.

The letters were sent to almost all of the major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Merck and Eli Lilly. The letters said ads for widely prescribed drugs, including Celebrex, Propecia and Yaz, did not include the paragraphs of precautions the agency required.

Though the texts of the ads varied, the agency’s objections to each ad were similar. One such ad was for Merck’s allergy drug Singulair. The ad read, “Allergy Medication Relief of Allergy Symptoms: Learn About a Treatment Option. http://www.SINGULAIR.com.”

The ad omitted “the most serious and frequently occurring risks associated with the drugs promoted in the links above,” the agency wrote in its letter to Merck, and the links “misleadingly suggest” that the drug was “safer than has been demonstrated.”

Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule, said Arnie Friede, counsel at the corporate law firm McDermott, Will & Emery: as long as pharmaceutical companies provided risk information within one click of their search ads — on the page that the ad linked to — they assumed they were in compliance. These letters made clear that was not the case.

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2 Responses to “The FDA on drug ads”

  1. Stan Says:

    Dearest Clementine:

    I believe ending drug ads would be a good thing and a small step toward regaining a shattered public confidence problem with the whole industry and government.

    Though the direct marketing and off label marketing to Doctor’s across the board is really what needs to stop.

    A huge area where progress needs to start is Pharma can pay the a new independent and uninfluenced FDA to do totally independent studies and clinical trials at Phama’s cost before any drug can come to market or be approved for use; but direct industry sponsored or financed drug studies and trials should be completely off limits and illegal.

    Then to take it one step further, an independent body of true citizen advocates should be involved in the process each step of the way to ensure integrity.

    Studies need to be designed to factor in all extenuating circumstances including adverse side effects, weigh other less intrusive methods of treatment, how it stacks up against treatment already in use, and complete withdrawal and discontinuation procedures for any drug or treatment before it comes to market.

    The last important factor above all; is the process should be made completely open and transparent; so no data, studies, protocol breaches, or doctors information is withheld from the public scrutiny.

    Pharma, the FDA, and Psychiatry have proven they can not be trusted with mountains of evidence against them and continued catosophic results.

    So in the interest of public safety and patient well being everything, and I mean everything should be out in the open for all to judge.

    Hope your having a good week at work, and are slowing down and stopping to smell those Spring flowers whenever you can.

    Yours Truly
    Secret Penguin Man

  2. Van Santos Says:

    Oh, I remember the time when Pharma could not play adverts on TV… then the law was lifted and next thing you know you can’t get away from them..

    I doubt we are going back to the days of complete banning.


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