Word: fda
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Dates: during 1970-1979
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...story in The Washington Post raised a few eyebrows in the medical and academic communities this week. Morton Mintz, in the November 23 edition of The Post, revealed that Robert H. Ebert, dean of the Medical School, had testified before an FDA committee in his capacity as a consultant for Squibb Beechnut...
Ebert and Lewis Thomas, dean of the Yale Medical School, both testified October 13 before the FDA in defense of Mysteclin-F, a fixed combination anti-infection drug manufactured by the pharmaceutical division of Squibb...
...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...