August 4th, 2005
Pharma Chief Says Drug Ad Limits Are “Human Rights Abuse”
By Gary Ruskin
In an expansive notion of the status of corporations as persons, MediaWeek reports that Billy Tauzin, the president of the Pharmaceutical Research Manufacturers of America (PhRMA), is claiming that restricting the advertising speech of pharmaceutical companies is a “human rights abuse.”
MediaWeek reports: “In June he [Tauzin] told Brandweek that he was skeptical about creating an enforcement mechanism to require companies to stay within the rules [PhRMA’s new advertising guidelines]. ‘We’re in a free speech area…to me that’s a human rights abuse’ if the rules were to prohibit companies from certain types of communications, he said.”
Tauzin’s idea of human rights is especially ironic given PhRMA’s opposition to compulsory licensing and parallel importation of essential drugs, which would help cure the diseases of real people.Since Tauzin is such a human rights visionary, maybe Amnesty International should give him a special award. How about the Tauzin Award for defending the “human rights” of non-humans?
And what’s next? Jail time for people who restrict the commercial speech of corporations?
Following is the whole MediaWeek article.
PhRMA Unveils New Guidelines
August 02, 2005
By Jim Edwards
New DTC advertising guidelines published by the Pharmaceutical Research Manufacturers of America (PhRMA) today contain few requirements that will add to marketers’ ethical and legal burdens in creating drug ads.
And PhRMA’s announcement will likely be eclipsed by a DTC ad review by the Food & Drug Administration that could start as soon as today, according to the Wall Street Journal.
The PhRMA guidelines do little to go beyond a press release PhRMA issued on July 21, which merely “encouraged” the industry to better target its audience.
The voluntary guidelines contain no penalties for transgressing the guidelines and no mandatory ad-free time period between a drug’s approval by the FDA and its consumer launch.
Those were two key issues that had been floated during the discussion period prior to the new guidelines being written.
The guidelines were spurred by recognition that inappropriate DTC advertising was giving the drug industry a bad name. “Some of it is well deserved,” said Bill Weldon, ceo of Johnson & Johnson, of the criticism.
The voluntary rules issued today call for companies to educate patients about diseases, act responsibly in targeting and promoting their medicines, and encourage them to highlight risks and preventative measures such as diet and exercise. The guidelines also encourage companies to spend an “appropriate” period of time telling doctors about new drugs before DTC advertising starts.
But they do not lay down any bright lines that the industry might fear to cross, beyond those already promulgated by the FDA.
The new rules appear to indicate that new PhRMA president Billy Tauzin, the former GOP congressman from Louisiana, has gotten his way in the industry’s internal, private debate about what the rules should say.
In June he told Brandweek that he was skeptical about creating an enforcement mechanism to require companies to stay within the rules. “We’re in a free speech area…to me that’s a human rights abuse” if the rules were to prohibit companies from certain types of communications, he said.
Tauzin said he favored “Some enforcement mechanism that’s reasonable that doesn’t necessarily impinge upon free speech.” That mechanism appears to have fallen by the wayside. Back in June, Tauzin said a third-party enforcement process “would be unacceptable” but he left the door open for a “third-party seal of approval, possibly some complaint review mechanism with a requirement to publish the complaints at the end of the year.”
In the end, the PhRMA guidelines contain only two rules with a hard-and-fast, no-fudge requirement. One ends so-called “reminder ads,” in which only the brand name is mentioned and no information about diseases or risks are mentioned, and the second states that companies should submit all new DTC ads to the FDA before broadcasting them.
The vast majority of drug companies already do that. About 50,000 pieces of promotional material are received each year by the FDA. Thomas Abrams, the director of the Food and Drug Administration’s Division of Drug Marketing, Advertising and Communications, said in May that there was no way the FDA could look at all of them.
A review board will also monitor the industry and periodically forward comments to the FDA, Tauzin said today at a press conference in Dallas. The board will hold “accountable” any of the 23 companies that have signed the new rules but transgressed them. But the rules contain no details of what power PhRMA intends to wield to ensure that accountability.
Tauzin said “the American public will judge them in the marketplace….[but] I don’t think PhRMA would ever expel a member. I think we would have some discussions about what it means to sign up to a code of conduct.”
Commercial Alert, a longtime PhRMA critic, was first out of the gate with its objections: “PhRMA’s new ‘guiding principles’ are utterly lacking in principle,” said a statement by Gary Ruskin, the pressure group’s executive director. “They are a public relations exercise that cloaks doing nothing in a stream of verbiage that sounds like doing something. They will cause no inconvenience for the drug industry and no real change of behavior.”
- Posted by Matt Clarke on August 10th, 2005