DTC Prescription Drug Advertising

Issue
In 1997, the U.S. Food and Drug Administration issued new guidance to pharmaceutical companies that engaged in direct-to-consumer (DTC) broadcast advertising. Since then, broadcast DTC advertising can mention both the product and condition it was designed to treat without having to include an exhaustive list of disclaimers. Advertising of prescription drugs has drastically increased since then.

AAF Position
The AAF supports the right of pharmaceutical companies to advertise prescription drugs directly to consumers, provided all claims are substantiated and appropriate disclosures are included in the advertising. Proposed moratoriums on pharmaceutical advertising would violate the First Amendment protection for commercial speech. Barring information from advertising will cause more harm to consumers who are not encouraged by an ad to see a doctor about an illness. Surveys show that these ads prompted more than 39 million to ask their doctor about a particular health condition. Advertising is an important source of information about pharmaceuticals.

Opposition
Opponents of direct-to-consumer advertising come from both sides of the political aisle. Some find televised advertisements for health conditions to be indecent and believe the Federal Communications Commission should regulate them. Others argue that advertising raises the price of prescription drugs or promotes unsafe dispensing and seek to remove tax deductions for advertising or moratoriums on advertising new drug products after the FDA approves them.

Legislation
S. 1082, the Food and Drug Administration Revitalization Act, introduced by Sens. Ted Kennedy, D-Mass., and Mike Enzi, R-Wyo. As introduced, this bill would have imposed three restrictions harmful to advertising: a two-year moratorium on advertisements for prescription medication, preclearance by the federal government of advertisements and authority for the government to mandate that certain language must be part of every advertisement. An amendment removing these restrictions was introduced by Sen. Pat Roberts, R-Kan., and approved by the full Senate after narrowly failing a committee vote. The amendment gives the FDA authority to assess monetary penalties for advertising found to be false or misleading and strikes the two-year moratorium, FDA preclearance and warning language requirements included in the original bill. The bill passed the Senate by a wide margin.

H.R. 2900, the Food and Drug Administration Amendments Act of 2007, introduced by House Commerce Chairman John Dingell, D-Mich., contained advertising provisions similar to S. 1082 as introduced: a three-year moratorium on new drug ads, preclearance of new direct-to-consumer advertising by the FDA and inclusion of warning labeling on new pharmaceutical products. An amendment introduced by Rep. Edolphus Towns, D-N.Y., and strongly supported by the AAF

President Bush signed the Food and Drug Administration Amendments Act (Public Law 110-85) into law on September 27, 2007. Attempts to add strict marketing restrictions were again rejected by conference committee members.

Updates
October 2007: The Food and Drug Administration announced it will undertake a new study of consumer reactions to direct-to-consumer drug advertising. The study will determine the how consumers view drug safety and side effects of a drug after seeing an advertisement for the ad.

May 8, 2008: House Energy and Commerce Committee Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., called for "significant restrictions" on direct-to-consumer advertising of prescription drug products, saying that the ads are "designed to mislead and deceive for the profit of pharmaceutical companies." Additionally, House Energy and Commerce Committee Chairman John Dingell, D-Mich., and Stupak sent letters to pharmaceutical company heads asking them to abide by a number of “guidelines,” including ," including a two-year moratorium on advertising new prescription drugs and to not market prescription drugs until a valid outcomes study of the product is completed.

May 22, 2008: As part of a settlement with 30 state attorneys general, Merck & Co. will submit all of its direct-to-consumer advertisements to the Food and Drug Administration and not broadcast them until the FDA gives specific approval.

June 19, 2008: Johnson & Johnson, Pfizer, Merck and Schering-Plough have agreed to a six-month moratorium on new drug advertising and will modify practices concerning actors portraying doctors and compensated endorsers in DTC ads.

Last updated: September 2008

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