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Consumer Reports urges FDA to keep ban on off-label drug promotion at hearing today

Consumer Reports survey: Americans don’t want FDA to allow drug companies to advertise medications for unapproved uses

YONKERS, NY — An overwhelming majority of Americans are opposed to allowing pharmaceutical companies to advertise a drug for a use that has not been approved by the U.S. Food and Drug Administration, according to a new Consumer Reports National Research Center survey. Consumer Reports will call on the FDA to keep its ban on the promotion of such “off-label” uses today at a hearing by the agency, which is considering easing the restriction for both drugs and medical devices.

“The FDA has a duty to ensure that drugs are safe and effective before they can be marketed to consumers,” said Lisa Gill, Deputy Content Editor for Consumer Reports Best Buy Drugs.  “Relaxing these rules would undermine the FDA’s mission and endanger patients by opening the door to false and misleading ads.  The FDA should protect patients by keeping the ban on off-label drug promotion.”

Gill will testify in support of the ban at the FDA’s two-day hearing along with Doris Peter, Director of the Consumer Reports Health Ratings Center, and a number of Consumer Reports Safe Patient Project advocates who have worked to address the risks posed by the promotion of off-label uses of prescription drugs.  The FDA is livestreaming the hearing on both Wednesday and Thursday, from 9am to 5pm EST.

While physicians may prescribe drugs off-label, it has been illegal for manufacturers to promote off-label uses since 1962.  In other words, a company can’t market an antidepressant as a diet drug, unless the FDA has reviewed the drug and determined that it is safe and effective for losing weight.  But recent federal court rulings have found that such off-label promotions are protected free speech, prompting the FDA to reevaluate this restriction.

Consumer Reports’ survey suggests that Americans favor maintaining the current ban by a large margin.  More than three quarters of respondents said that it’s highly important that the FDA fully vet medications to make sure they are safe and effective for a particular use.   An even larger majority — 84 percent — said that companies should not be allowed to advertise drugs for a use that hasn’t been approved by the FDA.

Recent research has found that people prescribed drugs off-label without strong scientific evidence have a 54 percent higher risk of suffering adverse side effects than those taking a drug for an FDA-approved purpose.   The consequences can be serious and even deadly.  In 2013, for example, Johnson & Johnson agreed to pay more than $2.2 billion in criminal and civil fines to resolve charges for promoting the antipsychotic drug risperidone (Risperdal) off-label to older adults, children, and people with developmental disabilities.  Federal officials charged that the company knew the drug endangered those patients, including increasing the risk of strokes in older adults.

Consumer Reports advises patients to ask their doctor or pharmacist whether a drug is being prescribed for an approved use.  Patients can also check for this information on the National Institute of Health’s website (www.dailymed.nlm.nih.gov), where they can search any drug and learn more about its approved uses by clicking on “Indications & Usage.”

If a drug is being prescribed for an unapproved use, patients should ask their healthcare provider whether the use is supported by well-designed studies and if it is better than approved drugs.  Patients should always make sure that someone has explained the risks and benefits of any prescribed medication, as well as other options.

NOTE:  Consumer Reports nationally representative telephone survey of more than 1,000 adults was conducted by the Consumer Reports National Research Center from October 13-16, 2016.  Margin of error is +/- 3.1 percent.