Thursday, July 21, 2005

Restrict DTC, but Extend the Patent for New Drugs

When the leading Republican member of Congress and a contender for the next president of the United States says it'’s time for the pharmaceutical industry to "clean up it's act" and suggests banning DTC advertising of new drugs for 2 years after launch (see "To Ban DTC or Not to Ban DTC, That is the Question"), you know that you are in trouble.

Should the industry fight back or "suffer the slings and arrows of politicians" until it all blows over? If it fights back, how should it fight back?

Many believe that the pharmaceutical industry is too timid and does not fight back when kicked (see, for example, "Marketing the Pharma Industry: The Empire Strikes Back" in the upcoming Summer 2005 issue of Pharma Marketing News).

The facts, however, do not support this view. According to a Center for Public Integrity investigation, the pharma industry lobbying efforts are "second to none"” (see "“Drug Lobby Second to None: How the pharmaceutical industry gets its way in Washington"). It has spent more than $800 million in federal lobbying and campaign donations at the federal and state levels in the past seven years and employs more registered lobbyists (625) than there are members of Congress. So let'’s not shed any crocodile tears regarding the industry's ability or will to fight back.

I am not privy to all the ways that the drug industry is fighting back against efforts to limit DTC and to be more transparent about drug side effects. In public statements the industry sometimes appears very timid, especially when criticizing reforms suggested by its political friends. The handling of comments by Bill Frist is an example. Behind closed doors, however, I am sure industry lobbyists and supporters are employing the strongest arms they have to twist Frist's arm and make him say "“uncle."

The industry is also employing PR and pharma CEOs are writing books (see "“A Call to Action: A Mea Non Culpa"” in the upcoming Summer 2005 issue of Pharma Marketing News) to push its main arguments that prescription drugs are not expensive, importing drugs from Canada is dangerous (they won this argument), and DTC advertising is really direct-to-consumer education.

I don'’t think the drug industry will win the DTC moratorium argument. Instead of following PhRMA's head-on confrontational approach and fighting such "bad policies"” and issuing voluntary codes of conduct, the pharmaceutical industry should push for a compromise that has some carrots in it for the industry.

My suggestion is to negotiate on two issues: a selective rather than universal DTC ban and extension of patent life of drugs.

Instead of an arbitrary ban on DTC for all new drugs, why not just ban DTC advertising of new drugs that have known serious side effects? Furthermore, the restriction could be provisional upon completion of post marketing studies that prove the safety of the drug in the marketplace. Incentives to holding back DTC ads could include extending the drug's patent life and preventing other companies from marketing "‘me-too"’ type of drugs while the advertising prohibition is in effect.

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