Should Amgen Inc. have known better?
That's a fair question following the Food and Drug Administration's demand that the Thousand Oaks-based biotech company pull a television ad for its psoriasis drug Enbrel.
The FDA has been questioning the safety of numerous prescription drugs being marketed on television. In a letter to Amgen, the agency contended that the ads overstated Enbrel's effectiveness while minimizing the risks.
The ad featured minimally dressed adults without any of the red lesions that are notable signs of psoriasis giving the impression that the drug is 100 percent effective, even though no studies show that.
Moreover, according to the FDA, the ad failed to convey that the drug has potentially serious side effects, including raising the risk of tuberculosis and the cancer lymphoma.
"They were showing patients on TV going to the beach with their shirt off who looked like they never had psoriasis," said Adam Walsh, a Jefferies & Co. analyst. "Sometimes the marketing departments at pharmaceutical companies push the envelope."
Amgen spokeswoman Nurha Hindi declined to discuss the matter in detail. "We are really digging into the letter and talking to FDA to understand their concern and act accordingly," she said.
Lately the FDA has gone after prescription pain relievers Vioxx, Celebrex and others over safety concerns. Merck & Co.'s Vioxx was advertised as a safe arthritis drug, only to be later linked to more than 25,000 cardiovascular deaths. Vioxx was pulled from the market voluntarily.
This month, an FDA panel strongly recommended against allowing direct-to-consumer advertising if Vioxx is allowed back on the market.
Pfizer Inc.'s Celebrex is still on the market, but the FDA ordered the company to withdraw its ads, saying they overstated benefits and minimized risks.
Last November, the agency ordered Pfizer to pull two television ads for Viagra, also noting they overstated that drug's effectiveness also while minimizing its risk.
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