Edwards Calls For DTC Ad Disclosure

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With debates over Medicare raging in Congress, Senator John Edwards has introduced legislation requiring pharmaceutical companies to disclose more information in direct-to-consumer advertising and promotions about risks, side effects and effectiveness.

The proposed amendment includes a fine up to $10 million for companies that don’t comply.

Edwards cited a Food and Drug Administration survey that found that 70% of general practitioners claimed drug ads confuse patients about the risks and benefits of medicine.

“Every time you turn on the TV, you get bombarded with drug commercials that promise miracles,” said Edwards, (D-NC) in a statement. “At a time when drug prices are skyrocketing, the last thing we need is big drug companies spending billions on misleading ads. We need to get critical health information out of the fine print so that consumers are informed.”

The amendment, which is co-sponsored by Senator Tom Harkin (D-Iowa), calls for drug companies to provide information about risks, side effects and proven effectiveness “as prominently as they hype purported benefits,” including large type warnings. It would also limit copycat drugs, which serve the same purpose as existing medications.

If passed, the requirement for large type warnings could make DTC advertising too unwieldy to be feasible.

The amendment comes on the heels of several high profile cases of alleged DTC marketing misconduct, including Schering-Plough being investigated by the Massachusetts U.S. Attorney’s Office for its sales, marketing and clinical practices (Xtra, June 3).

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