FDA Needs to Stand Up to Off-Label Marketing Efforts

The pharma industry is pushing back on efforts by the FDA to restrain off-label promotion of drugs. Public health would be harmed if a new rule is changed.

Americans are inundated on a daily basis with advertisements that push drugs treating everything from asthma to erectile dysfunction to hepatitis C. Nearly all of them minimize the side effects associated with the drugs, either in small type in a print ad or in a background voice that quickly lists potential adverse events.

It’s tough enough as it is for consumers to get a balanced impression of a drug through advertising, which is why recent pharmaceutical industry efforts to delay an FDA rule that would heavily police drug companies’ attempts to advertise a medication for unapproved uses is so troubling.

Off-label marketing, as it is also known, is promoting a drug for an indication that is not shown on a drug’s label because the FDA has not approved it for that purpose. In January, the FDA unveiled a final rule that aims to curb this practice. It would also require drugmakers to note on a drug’s labeling if a company intended a medication to be used for an unapproved use.

Last month, Big Pharma launched a first strike in its effort to rescind the new rule by filing a petition asking that the FDA rethink the rule as it would harm patient health by “chilling valuable scientific speech.”

The new rule would give the FDA more leeway to determine if manufacturers intended their drug to be used for unapproved purposes. If the FDA determined this was the case, they could then assess whether the company engaged in illegal promotion.

Although doctors are free to prescribe a drug for an indication not listed on its label, allowing widespread promotion of drugs for unapproved uses – including many where there is little or inconclusive data indicating it is effective – could have potential serious consequences for patients.

So why is the pharmaceutical industry so eager to halt the rule from taking effect? Easy. It all comes down to money

A study published last year found that off-label use of drugs is linked to higher rates of adverse events and side effects. The JAMA Internal Medicine study found that the rate of side effects was 54% higher in drugs that were prescribed for unapproved uses.

Other studies have found that between 50% and 75% of off-label use has little or no scientific evidence to back it up.

So why is the pharmaceutical industry so eager to halt the rule from taking effect? Easy. It all comes down to money. Why advertise a drug for one indication when you can do it for many others and thus increase sales of the drug?

While some off-label drug use is warranted – cancer drugs are routinely approved for only a couple of indications, yet doctors tend to prescribe them for a wide variety of cancers – it would be a serious mistake for the FDA to give in to Big Pharma’s stay request.

Should the rule be withdrawn, it would benefit drug companies’ bottom lines at the expense of consumer health. For that reason alone, the FDA should scuttle any attempts to undermine a rule that is intended to protect the public.


Jonathan Block

Jonathan Block

Jonathan Block is a freelance writer and former MedShadow content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including BioCentury, The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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