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Hoffmann-La Roche's estimated $70 million to $75 million direct-to-consumer ad campaign for its much-hyped obesity drug Xenical has had a disruption.

Days after a 60-second Xenical TV spot began running, the U.S. Food & Drug Administration forced the marketer to pull it.

FDA charged the commercial lacked fair balance and misled consumers in how it portrayed the drug's side effects and demonstrated who should use the product. Roche complied, with its agency spending several days tinkering with the spot before returning it to broadcast network and cable TV.


"Our goal was to be factual and set realistic expectations about the brand," a Roche spokeswoman said in a written statement. "We have responded to FDA's concerns and modified the commercial to enhance the prominence of fair balance."

The print portion of the campaign from Lowe Consumer Healthcare, New York, wasn't affected by the FDA action.

Roche had gone through the pre-clearance process with the FDA before the commercial was ever aired. As a result, company officials were aware of the FDA's objection before the spot ran on the Oct. 4 telecast of ABC's "NFL Monday Night Football" and other shows.

The pharmaceutical marketer intended to make changes as soon as it was possible, but the alterations couldn't be made in enough time to make that first scheduled buy, an executive familiar with the marketer's plans said. Roche opted not to forfeit the media time and hoped to satisfy the FDA by placing an altered spot on TV as soon as possible.

But, in a letter dated Oct. 6, the FDA said Roche should immediately pull the spot.

"Roche made a business decision," said Nancy Ostrove, chief of the FDA's Division of Drug Marketing, Advertising & Communications. "We have to make a decision on what's best for the public."

The FDA charged that the initial ad lacked fair balance because it failed to present the drug's possible side effects in a similar manner to that in which the drug's benefits were portrayed. In part, the FDA said "distracting sound effects" were played while the side effects were delineated.

On the other hand, the spot's "efficacy information is clearly presented without any intervening distractions," the FDA wrote.

Further, it objected to how the side effects were communicated, particularly the phrase "you may experience gas or oil with discharge."

Ms. Ostrove said that phrase was unclear.


The FDA also felt Roche misled consumers by failing to properly convey the product's recommended use and thus attempt to limit the pool of potential Xenical users.

In the initial ad, the male voice-over says, "If you're considerably overweight, ask your doctor for more information." At the same time, a phrase appears on the screen that reads, "Xenical is recommended for adults who are at least 30 lbs. overweight depending on height."

Each of the FDA's concerns were addressed in the altered ad, which is currently running.

The spot now includes toned-down music and changes to the listing of side effects. Further, voice-over says what appeared on the screen in the previous spot regarding who should use the product.


But the new ad largely looks and feels the same. The fast-moving spot, called "Facts," attempts to dispel myths that Xenical is a miracle pill, in part by mentioning that it won't make a person look like a supermodel as a model twirls on a runway.

"But," the ad says, "with Xenical and a reduced-calorie diet you can lose weight and that's a fact."

The side effect portion takes about a third of the 60 seconds.

By actually blocking fat intake, Xenical differs from previous weight-loss drugs that sought to control appetite.

Xenical went on sale in May and right away vaulted to the top of the U.S. retail market. Figures from consultancy Scott-Levin show Xenical had 49% of the $35 million in U.S. retail sales of weight-loss drugs during the month of September.

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