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Abbott Labs and Cytogen Corp. Receive Warnings from FDA Regarding Improper Advertising

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The FDA Division of Drug Marketing, Advertising and Communications has about three dozen employees to review 30,000 to 40,000 Direct-to-Consumer (DTC) ads each year. Lester M. Crawford, then Acting Commissioner of the agency noted that “our patience is sometimes worn thin” by all the advertising claims.

Several times each year, the FDA issues warnings to pharmaceutical manufacturers for a variety of reasons associated with their advertising claims and marketing approaches. Unsubstantiated or exaggerated claims of effectiveness, advertising a drug for unapproved uses, minimizing or omitting information regarding side-effects, and improperly casting doubt on similar drugs manufactured by competitors are but some of the ways in which prescriptions drugs are over-promoted.

This trend toward over promotion is precisely what caused the Food and Drug Administration to issue warnings against two biopharmaceutical companies, Cytogen Corporation and Abbott Laboratories Inc.

The FDA has determined the companies have exaggerated the effectiveness of their products while downplaying negative side-effects.

In a warning letter to Cytogen, the FDA admonished the company concerning its radio commercials, testimonial video, and website for the cancer pain drug Quadramet all of which suggested the drug was used for cancer therapy rather than as a pain reliever.

Furthermore the advertisements overstated the amount of relief the drug could provide and implied that it would be immediate.

Conversely, the drug’s side effects were concealed or minimized in the commercials. Quadromet is a radioactive drug, which can suppress bone marrow and produce radioactive urine for several hours.

In response, Cytogen President and Chief Executive officer Michael Becker stated that the FDA’s concerns were being addressed. “We are already cooperating with the FDA” he said. The questionable advertisements are no longer in circulation and the entire website is under review.

Similarly, in a second letter to Abbott Laboratories, the FDA claimed Abbott had, in a direct mail promotion, made unsubstantiated effectiveness claims and minimized the risks posed by the drug Survanta, used for treating respiratory distress in infants.

While the flyer’s descriptions and charts highlighted Survanta’s effectiveness, the FDA observed that dangerous side effects were “relegated to page three of the four page piece and is presented in small font in two lines at the very bottom of the page, below both the references and the footnotes.”

Survanta is made from bovine lung extract and can have dangerous side effects including unsteady heart rhythms and difficulty processing oxygen. The drug is not approved for babies weighing less then 600 grams or more than 1,750 grams at birth.

Abbott acknowledged receipt of the letter on July 15 and confirmed it was cooperating with the FDA and discontinuing the flyers. “The subject pieces under review are no longer being used.” Moreover, Abbott’s Ross Products Division is working with the agency on these issues, according to Ross’ spokeswoman Keri Butler.

As drug promotion on television and the internet becomes increasingly popular, it seems the regulation of advertising claims will continue to be an issue. However, the FDA’s recent actions suggest that false claims have the potential not to be financially profitable. As a result of the accusations against the companies, Cytogen shares were down 5 cents, or about 1 %, to close at $4.81 on the Nasdaq on Tuesday and Abbott shares closed down 6 cents at $46.35 on the New York Stock Exchange.

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