The FDA Amendments Act of 2007, also known as FDAAA, as in "open wide and say FDAAA," is a riveting 156-page read, and buried in its contents is a provision, known to its friends as 121 Stat. 890 Sec. 502(f)(1), that requires drugmakers to include a toll-free number in print advertisements for prescription drugs, for consumers to report adverse effects or negative side effects from those drugs.
(The FDA published a notice in the Federal Register on January 3, advising that the rule went into effect on January 1, 2008. Interestingly, although it says the rule goes into effect January 1, that doesn't mean that all drug companies must comply with the rule by January 1 -- the Federal Register notice says "In the preamble to the toll-free number proposed rule, the agency proposed that all manufacturers, dispensers and pharmacies subject to the rule be in compliance not more than 1 year after the effective date of the final rule." I guess only at the FDA does "in effect on Jan. 1, 2008" really mean "in effect one year later than Congress required.")
But what about TV ads? There's no requirement that drugmakers include that toll-free number in their television ads. And no doubt drug companies wouldn't want that requirement. Can you imagine a drug ad that said "Side effects may include bloat, foaming at the mouth, heart attack, hives, hallucinations, insomnia, excessive sleepiness, erections lasting longer than 4 hours, and compulsive gambling. Call 1-800-FDA-1088 if you experience any negative side effects while taking this drug." That certainly would tend to, um, accentuate the negative, if you will.
But having these toll free numbers on TV ads is arguably far more important. It's impossible to watch prime time TV without seeing several drugs an hour. People spend far more time watching TV than they do reading magazines. Drug companies spent twice as much on TV ads on Network and Cable TV in the first half of 2007 (nearly $1.6 billion) as they did on national magazines, sunday supplements and newspapers (just over $838 million). [Source: DTC Perspectives, "Spending Review," December 2007]
Consumers Union submitted a citizen petition to the FDA calling on the FDA to require that TV ads be required to include this toll free number as well. Here's the press release about it.
Consumers Union is circulating an online petition, and asking consumers to sign it in support of this request. To sign the petition, go here.
And what's that toll free number? 1-800-FDA-1088. You can also report a negative side effect through your doctor, or by going to www.fda.gov/medwatch