Tuesday, May 1, 2007

The pharmaceutical industry is partnering with broadcasters to kill legislation aimed at restricting drug companies’ advertising campaigns.

Debate is under way in the Senate on legislation to grant the Food and Drug Administration more power — and significantly more money — for drug safety. A vote on the bill is expected this week.

Under the measure, the FDA would have the discretion to bar pharmaceutical companies from advertising new drugs directly to consumers for the product’s first two years on the market.

But the pharmaceutical and television lobbies are not lying down in the face of a bill that could put a significant dent in sales. The Pharmaceutical Research and Manufacturers Association (PhRMA), the industry’s main trade association, is attacking the provision restricting TV ads from a patient-safety standpoint.

“Direct-to-consumer advertising empowers patients by increasing their awareness of diseases and available treatments. Banning this information — even for just a couple of years — is not in the best interest of patients and physicians,” said Billy Tauzin, president and chief executive officer of PhRMA. Mr. Tauzin is a former Republican congressman from Louisiana.

Sen. Pat Roberts, Kansas Republican, said he will attempt to kill the bill’s advertising provision on the basis that it violates free-speech rights. Mr. Roberts is expected to introduce an amendment to the bill that replaces the two-year moratorium on advertising with a fine for drug companies that produce dishonest or misleading ads.

The Advertising Coalition, which includes ad groups, broadcasting groups, newspaper and magazine publishers and food marketers, sent letters this week to senators arguing the ad curbs violate the First Amendment and are bad for medicine.

The drug industry has elevated television advertising in recent years as part of its marketing strategy. During the 1990s, television revenues from prescription-drug advertising hit about $4.5 billion, and have remained around $4 billion annually, according to the National Association of Broadcasters.

The bill is being spearheaded by Sen. Edward M. Kennedy, Massachusetts Democrat, and Sen. Michael B. Enzi, Wyoming Republican, and includes an array of provisions modifying how the FDA monitors drugs once they have been approved and are being sold on the market.

Regardless of the outcome of the advertising language in the bill, tougher drug-safety monitoring would be required of the FDA.

With the new money the bill grants the FDA, lawmakers want better tracking of drugs’ side effects. The reforms to drug-safety monitoring are a direct result of the increased risk of heart attacks associated with the pain-relieving drug Vioxx, made by Merck & Co. The side effects was discovered after the drug entered the market. Vioxx has since been taken off the market.

The extra funds would give the FDA the resources necessary to examine health records and health insurers’ data to find side effects with popular drugs.

The legislation also would give the FDA, for the first time, authority to impose monetary civil penalties on drug makers that do not follow through on safety studies.

“Pulling a drug from the market and denying patients who need it shouldn’t be the only tool available to the FDA,” Mr. Enzi said.

A national poll conducted by Consumer Reports National Research Center found that more than 60 percent of Americans agree that the FDA and Congress have failed to protect consumers from harmful prescription drugs.

“The bill would help return public trust in an agency that has been severely damaged by Vioxx, Paxil and other recent drug-safety disasters,” said Jim Guest, president of Consumers Union, an advocacy organization.

The legislation would increase the amount that drug companies pay the FDA to process new-drug applications. The FDA’s proposal to Congress calls for the drug industry to pay $393 million in annual fees, but Mr. Kennedy and Mr. Enzi propose increasing that by $80 million. Drug makers pay the fees in exchange for a quick review of drug applications.

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