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WASHINGTON, D.C. - Two bipartisan lawmakers today called for responsibility in drug advertising amid recent medical concerns over widely-promoted drugs like Vioxx. Congresswomen Rosa L. DeLauro (Conn.-3) and Jo Ann Emerson (MO-8) today introduced legislation that calls for safeguards in direct-to-consumer advertising immediately following FDA approval of a new drug for sale. The lawmakers argued that aggressive advertising campaigns have exposed thousands of Americans to potential risks because the rush to promote drugs has superceded doctors’ abilities to learn about the drug. The Congresswomen serve on the House Appropriations Agriculture subcommittee, which has jurisdiction over the FDA budget.
“The rush to promote new drugs should not impede FDA’s important oversight responsibility with respect to direct-to-consumer advertising,” said DeLauro. “While we recognize the critical, life-saving capabilities of new drugs, increasingly, we are seeing public health and safety at risk. Physicians and patients have a right to know that sufficient evidence has been accumulated in a large population about the drugs on the market.”
“It bothers me any time profits come before patients, and many of these ads are hawking drugs that have less expensive, equally effective alternatives. I don’t dispute a drug company’s right to sell the product once it has completed the FDA approval process, but I get concerned when that process is too short and inflexible. It has gotten to the point that aggressive ad campaigns threaten to displace concerns about the public health,” Emerson said. “The medicines Americans take should be promoted by doctors, not by drug representatives or advertising executives.”
Since 1997, the pharmaceutical industry has steadily increased its advertising budget, with approximately $4 billion being spent annually on direct-to-consumer advertising of specific prescription drugs. In comparison, the FDA office charged with ensuring that those ads are accurate was funded at less than a million last year. DeLauro worked to secure double that amount for the office in the Fiscal Year 2006 House Agricultural Appropriations Bill. Emerson supported the effort.
The Responsibility in Drug Advertising Act of 2005 supports the most critical aspects of drug safety and FDA. The legislation:
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sets up a three year moratorium on DTC ads with a possible waiver if the Secretary agrees that the product is of affirmative value to public health;
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provides authority to require corrective materials to be distributed if the companies violate the advertising moratorium;
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strengthens the Food and Drug Administration’s (FDA) authority to make post-market changes in labeling;
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has strong civil penalties that apply to the first and subsequent violations of the ad provisions or other requirements of the Act;
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has requirements for prominent display of information in advertising about the side effects of the drug, and for other important information;
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calls for a public education campaign on the risks of certain drugs.
The legislation will remedy problems that can emerge when post-market studies are conducted simultaneously with extensive advertising campaigns designed to maximize public consumption of the new drug – the promotion of Vioxx being but one example. Indeed, FDA scientists have estimated that over 50,000 patients may have died from Vioxx side effects that may well have been diminished had promotion been delayed.
The legislation will also give FDA authority to mandate that drugmakers change labeling should side-effects emerge once the drug is on the market. Currently, post-market labeling negotiations between FDA and companies often take months. The Responsibility in Drug Advertising Act would also give FDA final authority to determine specific wording when necessary to ensure the safe and effective use of the drug.
CONTACT: Kate Cyrul (DeLauro) 202-225-3661
Jeffrey Connor (Emerson) 202-225-4404 |
