Magazine article Drug Topics

FDA Wants R.Ph. Input in Detecting Outlaw Ads

Magazine article Drug Topics

FDA Wants R.Ph. Input in Detecting Outlaw Ads

Article excerpt

The rules of the game are still the same. Truthfulness and fair balance are still the benchmarks by which the Food & Drug Administration judges prescription drug advertising and labeling.

What's changed, said Cheryl Fossum Graham, M.D., acting director of FDA's Division of Drug Marketing, Advertising & Communications, are the marketing practices, target audiences, and therapeutic classes. They are "presenting different kinds of problems," she declared.

Pharmaceutical marketing used to be fairly simple, added Kenneth R. Feather, chief of FDA's marketing surveillance and enforcement branch within the same division. Basically, it consisted of medical or professional journal ads backed by promotion by detail men at the point of contact. Now, said Feather, manufacturers direct their messages to consumers, as well, and use a wide assortment of promotional vehicles, making the job of regulation more complicated than it's ever been.

The trouble with some of these promotional activities is that they are not always what they seem to be, continued David Banks, a pharmacist and senior regulatory review officer within FDA's Drug Marketing, Advertising, and Communications Division. Under the guise of being legitimate educational forums, they may contain biased information favorable to specific drugs and carry the endorsement of health-care authorities hired by the manufacturers of these drugs, he warned.

SAME STANDARDS: "While we regulate advertising and labeling under two separate sections," said Feather, "the standards and principles are basically the same for both." The message to manufacturers boils down to this: Be consistent with package inserts and present a fair balance of information on the benefits and risks of a drug.

According to Banks, much of what the drug industry does lives up to those standards and is of "immense value" to the public health. But sometimes, in the heat of competition, manufacturers fall short of expectations.

One area of "potential promotional violation" is the marketing of me-too drugs. In some cases, said Banks, marketing departments may overstate the value of these drugs in an effort to move product. Such biases are not likely to creep into the marketing of breakthrough drugs offering true therapeutic advances, he said.

Another major concern to the FDA, Banks continued, is the promotion of unapproved uses of drugs. There are "real risks" to the new patient population in this practice, he told ASHP members.

Some nontraditional promotional activities can also come under question, Banks went on. …

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