Senate softens FDA's standard for ads

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An effort to limit pharmaceutical companies' advertising campaigns for new drugs fell short in the Senate yesterday.

Rather than granting the Food and Drug Administration the power to prevent drug companies from advertising for a new drug for up to two years, a Republican lawmaker successfully implemented a weaker standard that allows the government to fine drug companies for false or misleading advertising. The fine for a misleading ad can amount to $150,000 per violation.

The advertising issue was part of a broad bill that increases pharmaceutical companies' payments to the FDA to about $393 million in fiscal 2008, compared with $305 million in fiscal 2007, which ends Sept. 30. The fees fund part of the FDA annual budget and are collected when companies file applications seeking approval of new products.

The bill, approved yesterday 93-1, includes an array of new drug-safety measures sparked by a spate of heart attacks and mental health issues over the past few years involving FDA-approved drugs, such as antidepressants and the painkiller Vioxx, that have marred the agency's reputation as a guardian against harmful drugs.

Imposing civil monetary penalties instead of taking drug ads off the air and out of sight did not sit well with consumer advocates yesterday.

"When a company can make more than a million dollars a day in drug sales, a $150,000 fine for running a misleading advertisement won't have much impact," said Bill Vaughan, a policy analyst in the health sector for the national watchdog group Consumers Union.

Sen. Pat Roberts, Kansas Republican, introduced the measure, saying it was a violation of the First Amendment right to free speech to not allow a company to advertise based on the government's discretion.

"My key concern with the underlying bill is the recognition that the ban on speech is based on what the FDA does not know, not what it knows," he said. "In other words, the government would ban speech even though it cannot identify an adverse event to support the ban."

Despite the weaker advertising language, the bill expands the FDA's ability to monitor drugs for side effects and to take quicker action if problems arise.

A key provision of the bill would require the FDA to review the safety of some potentially risky medications at 18 months and at three years after approval, and to conduct active, routine surveillance of large public and private medical databases to better track potential harmful patient side effects of drugs.

The legislation also would empower the agency to require pharmaceutical companies to conduct studies of drugs already on the market, and set deadlines for revisions of drug warning labels when problems occur.

"This legislation is going to make prescription drugs that our families take safer," said Sen. Edward M. Kennedy, Massachusetts Democrat, chairman of the Senate Health, Education, Labor and Pensions Committee.

The House is expected to take up the bill before the July 4 recess. Every five years, Congress reviews the amount pharmaceutical companies pay to the FDA to approve their drugs. Because those fees go toward the FDA's budget, the legislation must pass this year.

However, the House is expected to take a more narrow approach and focus on the amount of fees rather than on safety issues, said a committee staffer for the Energy and Commerce Committee.

"The scope of our bill will be much smaller than in the Senate," the staffer said, adding that the pharmaceutical companies' direct-to-consumer advertising will be addressed in some form.