Personal Injury Law

Drug Advertisements Not Reviewed By FDA

By Jane Akre

You've seen the ads for medications - people skipping through the fields, "Claritin Clear," or playing in a band, "Viva Viagra," or trying to fight plaque buildup they get from Fettuccine Alfredo and Uncle Alfredo.

Direct to consumer (DTC) advertising is relatively new. Until the mid 1980s, drug companies only spoke to doctors and pharmacists about prescription drugs and the condition they treat, never directly to consumers.

But are the multi-billion dollar print and broadcast ads consumers see today telling the truth and who is regulating them?

Over the counter (OTC) drug ads fall under the Federal Trade Commission, not the FDA which regulates advertising only for prescription drugs, certain kinds of medical devices such as hearing aids and lasers (used in LASIK), and contact lenses.

The FDA does not review or approve advertisements for drugs.  If a company appears to be violating the rules, they will receive an enforcement letter from the FDA, which is then posted online.

Even drugs that can cause serious injury may be advertised. However companies cannot use reminder ads for drugs with certain serious risks and boxed warnings.

DTC ads do not have to tell you the cost of a drug, whether there is a cheaper generic available, or if there is a cheaper drug with fewer risks.

Consumers Can Report False and Misleading

A new Food and Drug Administration (FDA) Web site has been established to help consumers evaluate prescription drug ads. 

Promotion provides information on which drug ads are misleading and which are believable.  

For example, the site says there are three different types of advertising consumers might encounter.

• Product Claim Ad - Talks about the drug's name, the conditions it treats, and talks about risks and benefits in a balanced fashion.  An Incorrect Product Claim Ad might feature a patient for whom the drug has not received FDA approval, such as a child.  The incorrect ad may not equally present the risks along with the benefits and may make false and misleading claims about what studies support its use and about how many users consider a drug, "the best."

• Reminder Ad - a correct reminder ad gives the drug's name but not its use, assuming the audience knows what the drug is for. The reminder ad does not have to contain risk information because no claims are being made. An Incorrect Reminder Ad will contain a graphic that shows how the drug works, ie clears breathing, when a reminder ad cannot suggest what a drug does, its benefit, or who should take it.

• The generic Help-Seeking Ads have been used recently for the smoking-cessation drug, Chantix. Help-seeking ads might describe a condition or disease symptoms and say "ask your healthcare provider what you can do," in a generic way. It may identify the company sponsor and provide a phone number or Web site to lead consumers to the drug being promoted.  They speak more generically about a condition and provide an 800 number to seek help.  An Incorrect Help-Seeking Ad will name the drug, therefore making it a product claim ad.  

Print product claim and reminder ads must include the following statement: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088."

Relatively hands off, the public is encouraged to report ads they feel are misleading or false.

Contact FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) about prescription drug ads you believe violate the law by being false, misleading, or lacking in "fair balance". #

Full post as published by InjuryBoard on January 06, 2009 (boomark / email).