Prior to the passage of the U.S. Federal Food, Drug and Cosmetic Act in 1938 that legitimized physicians as “learned intermediaries” and required a physician’s prescription for a pharmacist to dispense a drug to a consumer, Direct-to-consumer advertising (DTCA) was the overwhelming communications vehicle for promotion. Following passage of the 1938 legislation, DTCA declined sharply. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act shifted regulatory jurisdiction from the U.S. Federal Trade Commission (FTC) to the U.S. Food and Drug Administration (FDA), which to this day has responsibilities for regulating prescription drug promotional materials, both for physician- and consumer-oriented promotions.
The 1962 amendments outlined basic requirements for acceptable prescription drug marketing: Prescription drug promotional materials cannot be false or misleading; they must provide a “fair balance” coverage of risks and benefits of using the drug; they must provide a “brief summary” of contraindications, side effects, and effectiveness; and they must meet specific guidelines for readability and size of print. After some controversy involving the DTCA of an anti-arthritic drug in 1982, the FDA asked industry to comply with a “voluntary” moratorium during which time the FDA would assess the impact of DTCA on public health. In 1985 the FDA announced that the combination of current regulations and the Kefauver-Harris Amendments was sufficient to enable it to adequately regulate DTCA so as to protect public health, and that hereafter DTCA would be required to meet the same standards and criteria as promotional material aimed at health care professionals.
For a number of years, the FDA interpreted the “brief summary” provision as requiring the advertiser to provide the detailed information contained in the drug’s FDA-approved product labeling, thereby confining it to print form, typically in small print. However, under FDA regulatory precedents, there were two conditions under which firms could avoid the “brief summary” in TV advertising: first, if the advertisement were “help-seeking” in that only disease symptoms were mentioned, but no name of any drug was given, and the other was when only the name of the drug was mentioned without specifying its indicated use.
As DTCA began to grow in the mid-1990s, the FDA’s regulatory discretion was tested, and thus in 1997 the FDA felt obliged to clarify its regulation of prescription drug advertising, particularly for television ads. According to the FDA’s 1997 guideline clarifications, instead of requiring the lengthy “brief summary” taken from the product label insert, advertisements now needed only to include “major statements” of the risks and benefits of the drug, along with directions to information sources in addition to a physician, such as a toll-free phone number or a Web site.
The level of DTCA has increased considerably since 1994 (Tab. 1). The growth trend has been quite steady, and in particular there appears to be no material change in the slope of the trend line following FDA publication of the 1997 clarifying guidelines. After leveling off in 2002, by 2003 total DTCA spending increased to about $3.2 billion and to $4.1 billion by 2004, with most of the growth consisting of television advertising.
Table 1. Prescription drug promotion expenditures
|
|
1996 | 2001 | 2002 | 2003 |
| Physician office detailing | 26.8% | 25.2% | 25.1% | 17.2% |
| Hospital detailing | 6.0 | 3.7 | 4.1 | 3.2 |
| Retail value of free samples | 53.5 | 54.9 | 56.2 | 63.4 |
| Medical magazine advertising | 5.0 | 2.2 | 2.1 | 1.7 |
| Direct-to-consumer advertising (DTCA) | 8.6 | 14.1 | 12.5 | 14.5 |
| Total | 99.9 | 100.1 | 100.0 | 100.0 |
| Total promotion expenditures (in millions, mid-2000) | $9,764 | $18,617 | $20,379 | $24,460 |