Drug Industry Adopts Ad Guidelines

NEW YORK New direct-to-consumer 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 move will likely be eclipsed by a DTC ad review by the Food and Drug Administration that could start as soon as today.

The PhRMA guidelines do little to go beyond a statement the trade group issued on July 21, which “encouraged” the industry to better target its audience.

The voluntary guidelines contain no penalties for not following the standards 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 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 strict 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, a former Republican representative from Louisiana, has gotten his way in the industry’s internal, private debate about what the regulations should say.

In June, he said 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 [grievances] 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.

— A 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 FDA’s Division of drug marketing, advertising and communications, said in May there was no way the administration could look at all of them.

A review board will also monitor the industry and periodically forward comments to the FDA, Tauzin said at a press conference in Dallas. The board will hold “accountable” any of the 23 companies that have agreed to abide by the rules. 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 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.”