Marketing Formerly Dangerous Drugs

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Two scholars find that the removal of FDA health warnings prompts an increase in drug marketing.

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More than 131 million Americans use prescription drugs even though many prescriptions carry the threat of severe injury or death. In 2020, total expenditures on prescription drugs in the United States surpassed $348 billion, giving pharmaceutical manufacturers strong incentives to increase sales by marketing their products.

In a recent article, two scholars analyze how FDA regulations may impact a pharmaceutical manufacturer’s marketing efforts. Emily C. Lawler and Meghan M. Skira of the University of Georgia find that FDA’s removal of a so-called black box warning on a smoking cessation drug led its manufacturer to increase its marketing efforts for the drug.

FDA issues black box warnings to indicate serious side effects, such as injury or death, associated with a drug or medical device. For drugs with black box warnings, drug manufacturers must add an all caps and boldface warning label on the product’s packaging to alert the public, doctors, and other prescribers about the drug’s potential danger.

In 2009, FDA issued a black box warning for the smoking cessation drug known as Chantix after it received reports connecting Chantix to psychiatric issues including suicidal thoughts, suicidal behavior, hostility, and agitation. When FDA removed Chantix’s black box warning, the agency announced that it had overestimated the psychological risks associated with Chantix, especially in light of its benefits to those trying to quit smoking.

To measure marketing efforts after the removal of Chantix’s black box warning, Lawler and Skira analyze both direct-to-consumer advertising as well as monetary and in-kind payments to physicians by Pfizer, the drug’s manufacturer.

For direct-to-consumer advertising, Lawler and Skira find a “significant, large, and robust increase in national TV advertising expenditures for Chantix following the boxed warning removal.”

Lawler and Skira focus their analysis of direct-to-consumer advertising on national TV advertising because it accounts for around 85 percent of Chantix’s annual total advertising spending. After FDA removed the black box warning on Chantix, Pfizer’s national TV advertising spending for the drug increased by about $20 million, according to Lawler and Skira. They claim that this increase represents a 71 percent increase in national TV advertising compared to Chantix’s average spending while the black box warning was in effect.

For drugs with a black box warning, the manufacturer must disclose all product warnings in direct-to-consumer advertising, Lawler and Skira note. Once FDA removes a drug’s black box warning, the manufacturer must still disclose risk information in most advertisements; however, Lawler and Skira explain that because of the black box removal, a manufacturer can run special advertisements that do not contain any information about the drug’s risks or benefits.

In addition to observing an increase in direct-to-consumer advertising, Lawler and Skira also find that the removal of the black box warning increased Chantix’s monetary and in-kind payments to physicians. The latter of these, known as physician detailing, includes payment for “meals during visits from sales representatives, compensation for travel, speaking engagements, and consulting, as well as research-related payments.”

After FDA removed Chantix’s black box warning, physician detailing relating to Chantix increased significantly, according to Lawler and Skira. They find that, for physicians practicing in an area that has above average smoking rates, the probability of a physician receiving Chantix-related payments increased by 20 percent relative to the probability before the black box warning removal. Their study also indicates that, in these above-average smoking areas, the additional spending equals about $58 per 100 physicians per year.

Lawler and Skira claim that their results indicate that Pfizer’s marketing efforts increased in response to the black box warning removal, and not merely because Pfizer increased physician detailing for all of its products. Furthermore, they reason that, if the sole purpose of Pfizer’s increased physician detailing for Chantix was to inform doctors of the black box removal, the length of increased efforts would have been shorter than the duration they witnessed. Lawler and Skira suggest that the prolonged marketing efforts show that Pfizer increased its overall promotion efforts for Chantix, which likely contributed to the dramatic increase in Chantix prescriptions following the black box warning removal.

In their article, Lawler and Skira conducted only a single case study. But because FDA has removed at least one black box warning each year during the past several years, Lawler and Skira argue that their study could have important policy implications given that over 400 prescription drugs currently have black box warnings.

Lawler and Skira’s study shows what they see as a possible hidden danger in removing black box warnings for these drugs, as this may lead to a significant increase in marketing and overprescribing.