Researchers do not know all risks at the time FDA first approves a drug for marketing. Balanced . The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85 ) included some of those provisions, such as new industry fees for the advisory review of DTC television ads; expanded authority of the Secretary of Health and Human Services (HHS) to require certain disclosures and statements; and civil monetary penalties for false or misleading ads. In 2007, they accounted for over 90% of spending. In 1962, Congress added Section 502(n) to the FFDCA to give the FDA the authority to regulate not only labeling, but also prescription drug advertising, including DTC advertisements, and other descriptive printed matter. However, Congress prohibited ("except in extraordinary circumstances") FDA from issuing any regulations that would require prior approval of the content of any advertisement. Under them, advertisements had to have four basic attributes:
(1) they could not be false or misleading;
(2) they had to present a fair balance of information about the drug's risks and benefits;
(3) they had to contain facts relevant to the product's advertised uses; and
(4) in general, the advertisement's "brief summary" of the drug had to include every risk listed in the product's approved labeling. When FDA wrote the 1969 regulations, industry advertised its drugs to physicians through print ads in medical journals. The guidance made clear that DTC broadcast advertisements had to include what FDA called the "major statement"—the product's most important risks. This had to be in the audio portion of the advertisement, and could be in the video portion as well. Letters. Does DTC advertising lead to better diagnosis, treatment, or disease management? Industry wants to increase sales, and consumers want to actively participate in decisions about their own health. Legislators with concerns about DTC advertising still have a range of options to address those concerns. Activities for Which FDA Already Has Authority

Congress could urge FDA to act more aggressively in its review of ad content, consumer education, and enforcement. Increase Post-Publication Review

Although the law explicitly prohibits FDA from requiring pre-publication review and approval of an ad, it does require the manufacturer to submit the ad to FDA upon its release. FDA could:
Do a more complete and timely post-publication review of all DTC ads. Expand Industry-Independent Consumer Education

Critics who question the educational component of DTC advertisement have suggested alternatives to consumers' relying on the benefit and risk information gained through submitted DTC ads. FDA could also use that information to provide patients with medication guides outlining the risks of particular drugs. Congress could encourage FDA to take such steps more often, use the new FDAAA-authorized tools, and even set target goals for increased enforcement activity. The most extreme would be a total ban on DTC drug advertising. These include additional warnings to inform consumers that this drug was approved based on testing of only a few thousand people and that it may be dangerous to your health in ways that this limited research has not yet revealed; a statement that FDA does not certify that this drug is more effective, safer or cheaper than other drugs in its class; changes to the tax code to make DTC advertising expenses not deductible and to add a windfall profits tax to fund NIH-controlled comparative effectiveness studies and their dissemination. Require Pre-Release Review and Approval

Congress could mandate that FDA review and approve all or a subset of DTC ads prior to their release to the public.
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. Regulations—written at a time when most ads were printed in medical journals for a physician audience—require 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.