Compulsory Candor

The ad, which ran in the A.M.A. Journal and other professional publications last June, was similar to hundreds of other pitches for drugs. Aimed at the doctors who write prescriptions, Lederle Laboratories' illustrated three-page spread implied, among other things, that Minocin is superior to all other available tetracyclines and effective against a strain of staphylococcus bacteria. Yet a follow-up ad, which ran in the same journals nearly three months later, was strikingly different. It quoted a statement by the U.S. Food and Drug Administration that the earlier claims were misleading. It also conceded that Minocin is a tetracycline variation with all the limitations of similar medications, and that tetracyclines are not the first choice in fighting staphylococcus infections.

Lederle is only one of many established companies to make such a confession. In recent months, for instance, Sandoz Pharmaceuticals has retracted some of its claims for its trademarked tranquilizer Serentil. Marion Laboratories has acknowledged that Triten is chemically similar to at least one antihistamine. Ortho Pharmaceutical Corp. has conceded that its Ortho-Novum 1/50-21 contains no less estrogen and is in no way superior to other contraceptives with similar ingredients. All told, 15 companies, including most of the country's major drug manufacturers have publicly admitted errors in advertising 23 out of the thousands of drugs on sale. On 33 other occasions, the pharmaceutical houses have sent out "Dear Doctor" letters to every practicing physician in the country, informing them of misstatements in advertising or other promotional material. Such candor is now compulsory. Under a 1964 law, the FDA adopted various regulations to ensure the accuracy and truthfulness of prescription-drug advertising.*

Initially the regulations proved hard to enforce as pharmaceutical producers complied slowly, if at all. When the FDA tried criminal and civil litigation, it found that cases took as long as three years to conclude. Wanting faster service, the FDA switched to "Operation Candor," and required companies whose advertising it found misleading to notify physicians by first-class mail. More recently, the agency began to require remedial advertising, specifying that the corrections must appear in at least two issues of each publication that carried the offending announcement. Of late, this policy has been carried out vigorously.

Drug manufacturers are increasingly unhappy about the FDA approach. With more than 300,000 practicing physicians in the country, the cost of a letter to each can easily exceed $40,000. A two-page spread in the A.M.A. Journal alone can set a company back a minimum of $5,000. So far, however, no company has refused an FDA request for recantation. Nor is one likely to, for the alternative could be even more expensive. The law gives the FDA the authority--upheld in five cases--to seize any drug that it deems mislabeled.

*The Federal Trade Commission, which oversees advertising for nonprescription drugs, recently cited three manufacturers of patented headache remedies for misleading claims. The commission has sought but not yet won their agreement to devote 25% of their advertising budgets for the next two years to remedial ads.

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