Prescription drug manufacturers are projected to spend $2 billion on direct-to-consumer (DTC) advertising in 2000, appealing to consumers to influence physician prescribing. DTC advertising appears in printed media, on radio and television, and on the Internet. The U.S. Food and Drug Administration (FDA) requires all prescription drug advertisements, including DTC advertisements, to be accurate and non-misleading in their claims of safety and efficacy, and to include a "Brief Summary" of the product's indications, risks, and possible side effects. To meet this requirement, drug companies typically reprint information from product package inserts, which appear as blocks of small print in the advertisement, even though this volume and level of detail about the product are not required.
However, the FDA does not have authority to "pre-approve" proposed advertisements unless requested to do so by a drug company. If the FDA finds a violation or violations in a particular advertisement, the agency usually issues a warning to the sponsoring company, which typically withdraws the advertisement; the company may later issue a modified version. The FDA does not impose penalties or other sanctions against manufacturers who broadcast or publish false or misleading information.
This "In Brief" summarizes the findings from a recent AARP Public Policy Institute study of the impact of DTC printed advertising as a source of information for consumers about medications. The report highlights the perceptions of older consumers (age 60 and older) in particular. Key findings suggest that printed DTC advertising is less informative, in certain respects, for older consumers than for their younger counterparts.
Sixty-five percent of consumers report having seen a printed DTC advertisement.
- One in three of these consumers reports not noticing the "small print" information about risks and potential side effects associated with the product advertised. Sixty-six percent of those in the 18-39 age group notice the small print, compared to only 48 percent of consumers age 60 and over.
- Only 34 percent of those who report noticing the small print say they "usually" read it.
Sixty percent of consumers who have seen printed DTC ads say that the ads "usually" contain sufficient information to convey clearly that the medication is available by prescription only.
- Older consumers are less likely than consumers under age 60 to say that the ads "usually" clarify that a prescription is required.
Half of consumers who report having seen a printed DTC advertisement affirm that the ads usually contain enough information about risks and possible side effects.
- Sixty percent of the 18-39 age group say the information is usually sufficient, compared to 43 percent of consumers age 60 and older.
Fifty-one percent of consumers who report having seen a printed DTC advertisement think that the ads accurately portray degrees of risk and likelihood of side effects of the product.
- The remaining consumers are divided in assessing whether the ads understate (21 percent) or overstate (17 percent) the risks and potential for side effects. A significant number, answering "don't know" (11 percent), are unable to make an assessment.
Fifty-four percent of all consumers report that their physicians "usually" talk to them about product risks or potential side effects when they are prescribing.
- Seventeen percent of consumers age 60 and older report that they "rarely" have such conversations with their physicians, compared to 10 percent of consumers age 18-39 who respond in this way.
Public policy has a role in addressing consumers' needs for information about prescription drugs, especially in response to the effects of DTC advertising.
- If given authority by Congress, an agency such as the FDA could take additional steps to assure the quality of information in DTC advertisements, such as: requiring prior approval of advertising content; requiring all DTC advertisements to include standardized warning messages, comparable to requirements for cigarette advertising; developing and refining standards for information dissemination; and imposing sanctions for false or misleading DTC advertisements. Further research, especially research that evaluates DTC advertising content, would be helpful to inform the development of some of these options.
- To complement regulatory efforts, the FDA or another federal agency responsible for promoting public health could design and sponsor public information campaigns about prescription drugs in general, and about their uses. To pay for public education, policymakers could consider tapping existing revenues from the "user fees" that drug manufacturers pay to the FDA as part of the drug approval process.
- State and federal policymakers, especially those that act as prescription drug purchasers, could review their standards relating to physician prescribing and counseling, and place priority on compliance or enforcement.
- AARP Public Policy Institute Issue Paper #2000-04 (April 2000). The data were obtained through telephone interviews conducted by ICR, Inc. with 1,310 consumers in December 1998, weighted to represent the U.S. adult population. Sampling error is plus or minus 3 percentage points. Differences in survey responses are reported only when statistically significant.
Written by Lisa A. Foley and David J. Gross, AARP Public Policy Institute
May be copied only for noncommercial purposes and with attribution; permission required for all other purposes.
Public Policy Institute, AARP, 601 E Street, NW, Washington, DC 20049