Changing The Rules
Poor beleaguered PHARMA: on top of all the bad press it has gotten recently comes word that the FDA may be imposing new rules on drug advertising. From the Boston Globe:
Regulators are becoming less tolerant of what they see as excessive claims. In January, for example, the Food and Drug Administration began requiring Bayer HealthCare Pharmaceuticals, maker of the birth control pill Yaz, to launch a new ad campaign to correct earlier claims about treating headaches and acne - uses not approved by the FDA.
Last month, an advisory committee to the FDA unanimously recommended what could be the biggest change: It urged the agency to adopt the "drug facts box" format as its standard - a proposal that, if implemented, could radically improve drug information for consumers. A fact box is a concise summary of a drug's benefit and side effects, similar to the nutrition information boxes on food labels.
Such fact boxes would be included in the consumer handouts that pharmacists give patients with prescriptions. They might also eventually appear on the official FDA drug labels and in magazine and newspaper ads, replacing the fine-print summaries that regulators now require.
Why the push to curb drug advertising? Well, for one thing, consumers tend to spend more time watching drug commercials on television than they do with their doctors, and those ads imply that those watching the ads might be at greater risk for a particular illness than the actually are. Further, the ads downplay side effects or state them so ambiguously that that they seem to be mild, rather than potentially dangerous.
Other studies show how ads can mislead. In 2007, a study published in the Journal of Health Communication said that even some ads that detailed side effects managed to state them in a way that stressed benefits, not risks. For instance, instead of using a strong, declarative statement such as "common side effects are . . ." an ad for Flonase, a nasal allergy spray, said, "If side effects occur, they are generally mild and may include headache, nosebleed, or sore throat."
This is potentially worrisome because other studies, including one in 1999 in the Journal of General Internal Medicine, showed that direct-to-consumer ads are very powerful: 54 percent of people in one survey either asked for a prescription or asked a doctor for more information because of an ad. And ads are omnipresent; drug companies spent about $5 billion on direct-to-consumer advertising in 2007, more than twice the total FDA budget. [Emphasis added]
Obviously that $5 billion ad budget was money well-spent for the pharmaceutical companies, but hardly beneficial to the people who watched the commercials, given the way the commercials are presented. Cleaning up the television and print commercials with a little old-fashioned "truth in advertising" might change that imbalance.
And that would be a welcome change.
Regulators are becoming less tolerant of what they see as excessive claims. In January, for example, the Food and Drug Administration began requiring Bayer HealthCare Pharmaceuticals, maker of the birth control pill Yaz, to launch a new ad campaign to correct earlier claims about treating headaches and acne - uses not approved by the FDA.
Last month, an advisory committee to the FDA unanimously recommended what could be the biggest change: It urged the agency to adopt the "drug facts box" format as its standard - a proposal that, if implemented, could radically improve drug information for consumers. A fact box is a concise summary of a drug's benefit and side effects, similar to the nutrition information boxes on food labels.
Such fact boxes would be included in the consumer handouts that pharmacists give patients with prescriptions. They might also eventually appear on the official FDA drug labels and in magazine and newspaper ads, replacing the fine-print summaries that regulators now require.
Why the push to curb drug advertising? Well, for one thing, consumers tend to spend more time watching drug commercials on television than they do with their doctors, and those ads imply that those watching the ads might be at greater risk for a particular illness than the actually are. Further, the ads downplay side effects or state them so ambiguously that that they seem to be mild, rather than potentially dangerous.
Other studies show how ads can mislead. In 2007, a study published in the Journal of Health Communication said that even some ads that detailed side effects managed to state them in a way that stressed benefits, not risks. For instance, instead of using a strong, declarative statement such as "common side effects are . . ." an ad for Flonase, a nasal allergy spray, said, "If side effects occur, they are generally mild and may include headache, nosebleed, or sore throat."
This is potentially worrisome because other studies, including one in 1999 in the Journal of General Internal Medicine, showed that direct-to-consumer ads are very powerful: 54 percent of people in one survey either asked for a prescription or asked a doctor for more information because of an ad. And ads are omnipresent; drug companies spent about $5 billion on direct-to-consumer advertising in 2007, more than twice the total FDA budget. [Emphasis added]
Obviously that $5 billion ad budget was money well-spent for the pharmaceutical companies, but hardly beneficial to the people who watched the commercials, given the way the commercials are presented. Cleaning up the television and print commercials with a little old-fashioned "truth in advertising" might change that imbalance.
And that would be a welcome change.
Labels: PHARMA
posted by Diane at 3:45 AM
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