Direct-to-Consumer Advertising of Prescription Drugs (CRS Report for Congress)
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| Release Date |
May 20, 2009 |
| Report Number |
R40590 |
| Report Type |
Report |
| Authors |
Susan Thaul, Specialist in Drug Safety and Effectiveness |
| Source Agency |
Congressional Research Service |
Summary:
A phenomenon that has become more and more important over the last decade, direct-to-consumer (DTC) advertising has grown from about $800 million in 1996 to over $4.7 billion in 2007. Its supporters point to more informed consumers who then visit their doctors and become more involved in their own treatment, leading to better and earlier diagnosis of undertreated illnesses. The critics believe that industry's presentation of the balance of drug benefit and risk information may encourage the inappropriate use of advertised products and lead to higher than necessary spending. In addition to concerns with accuracy and balance, health professionals point out that DTC ads rarely mention alternative treatments, such as other or generic medications or non-drug interventions.
In 1962, Congress gave the Food and Drug Administration (FDA) certain authorities to regulate prescription drug advertising. Except in extreme circumstances, the law does not allow FDA to require pre-release review of ads. Regulationsâwritten at a time when most ads were printed in medical journals for a physician audienceârequire that all drug ads disclose all of a drug's known risks.
However, as drug makers considered moving into broadcast advertising and wanted to get their messages to consumers, they noted, without explicit guidance from FDA, the difficulty in including all risks in the format of a 30-second commercial. FDA issued guidance in 1999 stipulating that broadcast ads had to include the advertised product's most important risks in the audio portion of the advertisement and should give sources where more complete risk information about a drug would be available.
FDA reviews ads once they are launched, and its enforcement options are notice-of-violation and warning letters, criminal prosecution (through the Department of Justice), civil monetary penalties, product seizures, and withdrawal of approval for sale. Despite these activities, Members of Congress and the public ask what FDA could do differently in light of the safety problems involving some heavily advertised medications.
Congress could consider a variety of options to allay concerns about DTC drug advertising. It could encourage FDA to expand activities allowed under current legislative authority, including provisions in P.L. 110-85 (the FDA Amendments Act of 2007): FDA could increase post-publication review of ads, expand its role in consumer education, and increase its enforcement activities. Other possible options would require Congress to grant new authority so that FDA could require pre-release review and approval; require changes to ads; use stronger enforcement tools; require data collection; require public posting of risk information; prohibit DTC ads when a drug is first approved; and set limits on the timing and placement of ads. Congress could go beyond FDA to encourage other industry-independent entities to provide public education or set standards; it could also use tax and other financial incentives to make DTC advertising less profitable to industry.
This report will be updated periodically.
