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Quick Guide To Regulating Television Drug Ads






The United States is one of the few countries in the world that allows direct-to-consumer advertising of prescription drug products, as cited by the Food and Drug Administration (FDA).

1962 - Regulation of prescription drug labeling and advertising - President John Kennedy

 

Shortly after Congress granted the FDA statutory authority to regulate prescription drug labeling in 1962, the relaxation in the regulations concerning DTCPA began. 

1997 - Easing of broadcast DTCPA regulations  - President Bill Clinton

Many believe that the relaxation of the rules for Direct-to-Consumer broadcast advertising in 1997 was responsible for the deluge of direct-to-consumer-pharmaceutical-advertising (DTCPA) that we experience today.

Prior to 1997, the FDA prohibited using the drug's brand name and benefits in the same advertisement.  Easing this regulation, eliminated a source of confusion for consumers. Prior to this, the companies operated under rules governing advertising to physicians, which allowed "reminder" advertisements that uses the drug's name but didn't say what it was intended to treat. This policy change made it easier for drug companies to advertise on television  because it eased the type of risk disclosure needed, states the School of Journalism and Communication at the University of Oregon.

Post 1997, the budgets for consumer drug advertising more than tripled to $1.2 billion in 1998.  Direct-to-Consumer-pharmaceutical advertising is an effort made by a pharmaceutical company to promote its prescription products directly to patients, usually through popular media like television, newspaper, magazines, internet, billboards, radio and direct mailings.  Television advertising takes up the bulk of advertising dollars, but internet spending is not far behind.

According to the GAO, U.S. Government Accountability Office, Drug company spending on DTC (drug-to-consumer) advertising--such as that on television and in magazines--of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development.


2004 - Complete prescription information was eliminated  from ads - President George W. Bush

 

Even in 2004,  the FDA further relaxed regulations concerning DTCPA.  Since then, the need to reprint complete prescribing information in print product claim ads was eliminated from ads and the inclusion of a “simplified brief summary” was permitted.  This change allowed pharmaceutical companies to present information on only the “major risks” and in simplified language that would be easier for the average consumer to understand.


New Zealand is the only other country that allows DTCPA on prescription drugs and the ability to include product claims.  Most other countries don’t allow DTCPA at all.  Canada, however, does allow ads to mention either the product or the indication, but not both.   The pharmaceutical industry and lobby groups have tried unsuccessfully to overturn bans against DTCPA in Canada and other countries or regions, such as in the European Union.  Notably, in 2008, 22 of the 27 EU member states voted against proposed legislation that would have allowed even limited “information to patients” to be provided.



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