Earlier this week, the U.S. Food & Drug Administration announced that it is stepping up its enforcement related to misleading prescription drug advertising and is beginning a new rulemaking that will effectively put an end to most television commercials that promote prescription drugs.
In the FDA's rulemaking, the FDA is proposing to remove the "adequate provision" exception, which allowed advertisers to include only major risks in advertising and then direct consumers to another location (such as a website or toll-free number) for full safety information. By requiring full safety information to be presented in broadcast advertising, it will make it nearly impossible – as a practical matter – for pharmaceutical advertisers to run television commercials.
In announcing the rulemaking, Health and Human Services Secretary Robert F. Kennedy, Jr., said, "Pharmaceutical ads hooked this country on prescription drugs. We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising."
The FDA also announced that it is sending thousands of letters to pharmaceutical companies, warning them to remove any misleading ads they are running. In the letter, the FDA said, "FDA is taking action to rein in violative ads. Going forward, FDA intends to take aggressive action and ensure continuity with the law." The FDA also indicated that it had sent approximately 100 cease and desist letters to companies that it had identified as running deceptive advertising.
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