Should TV drug ads shorten list of side effects?

Rate this post

We’ve all been there. You’re sitting on your couch watching a good TV show and it’s interrupted by a drug company commercial claiming to have an answer to a fill-in-the-blank condition. A funny-sounding drug name is revealed followed by a recital of drug side effects, some which can sound pretty scary. Do you get confused by this list? The FDA is planning to study that.

In February, the FDA announced that it would study the potential impact of shortening that list of drug side effects on TV drug ads to those that are “serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad.” For example, the ad could rattle off a couple of major side effects – let’s say hair loss, weight gain, and death – that would be followed by a statement like, “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it.”

Currently, drug companies are required to include a “major statement” of risks—those risks most commonly associated with the drug—and other major risks that may be less frequent but could result in serious harm or death. The FDA is concerned that the length of a “major statement” can be too long and result in reduced understanding of the risks by the consumer and minimize the most important risks.

We’re concerned that this proposed study could lead to a situation where consumers are less informed about a drug’s risk. We shared our concerns about this proposed study with the FDA saying that we think this study is unnecessary and could lead to consumers getting less information about a drug than is currently required. If the list of drug risks seems long, it’s understandable that a consumer may have questions about the drug’s safety. Doctors should encourage this type of questioning from their patients and they should be honest about all of the drug’s risks and benefits, and not hide any financial relationships they have with drug companies.

Let’s be upfront. Consumers Union has consistently opposed direct-to-consumer ads for both drugs and medical devices because they are often misleading, drive up health care costs, and lead to needless suffering by improperly characterizing a drug’s benefits, risks and targeted population. Only in the US and New Zealand do we allow companies to market their drugs directly to consumers. For some interesting background on Consumers Union’s work on drug safety, check out our hilarious ode to drug ad side effects from 2007:

We agree with drug safety advocate Kim Witczak that if we have to permit these ads, at the very least, those drug ad warnings should be strengthened, not reduced.

You can read our full comments to the FDA here. Unfortunately, the deadline has passed to give FDA your public comments, but if you’re on Twitter, you could tweet at them. We’ll continue to voice our concerns about limiting important drug safety information. The public should be more informed about drugs’ potentially harmful risks, not less.