The Great Off-Label Debate
The FDA consults stakeholders over plans to loosen restrictions on off-label drug marketing in the US
As part of a review on the regulatory framework around the promotion of off-label marketing, the FDA recently held a two-day public hearing to give patients, caregivers, advocacy groups, physicians and pharma companies the opportunity to discuss the pros and cons of disseminating off-label drug information (1). The aim of the meeting was to find out how increased communication from pharma companies on off-label use might impact public health.
Pharma companies have lobbied Congress for some time to loosen FDA restrictions against off-label drug marketing. Since doctors are allowed to prescribe medicines for unapproved uses, pharma companies have argued that they should be able to disseminate truthful information about off-label drug use and to discuss relevant research outside the scope of the initial FDA review of a drug, or research that occurred after a drug was approved.
On the first day of the meeting, held on November 9 at the FDA’s White Oak Conference Center in Silver Spring, many of the discussions revolved around whether the First Amendment gives companies the right to talk about off-label product use – a growing problem for the FDA given that some companies have initiated free speech lawsuits against the agency. In a statement about the hearing, Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl, explained (2), “The market for medicines is changing rapidly as alternative payment models proliferate and novel decision tools like value frameworks are being applied[...] it is important that biopharmaceutical companies be able to share appropriate science-based information.”
A great deal of emphasis was placed on off-label drug use in children because so few pediatric medicines are available, which makes off-label drug use inevitable. On the second day of the hearing, however, some patients gave their account of how they had been injured after receiving off-label medicines or using an off-label medical device.
According to a recent poll by Consumer Reports, 84 percent of Americans do not want companies to be allowed to advertise drugs for a use that has not been approved by the FDA (3). Lisa McGiffert, Director of Consumer Reports, spoke at the hearing and added, in a press release, “Relaxing the current rules would dismantle a legal firewall that has protected Americans from false and misleading drug advertising for more than half a century.” She referred to the Congressional decision to outlaw off-label marketing in 1962, following the widespread off-label promotion of the drug thalidomide, which led to birth defects worldwide.
No decision will be made following the meeting, but the FDA hopes to learn more about the possible benefits of off-label drug marketing for clinical decision making, research, coverage, and reimbursement.
- FDA, “Manufacturer communications regarding unapproved uses of approved or cleared medical products; public hearing; request for comments”, (2016). Available at: bit.ly/2emiOJV. Last accessed November 10, 2016.
- PhRMA, “PhRMA Statement on FDA Communications Hearing,” (2016). Available at: onphr.ma/2fHRDan. Last accessed November 10, 2016.
- Consumer Reports, “’Off-label’ drug use,” (2016). Available at: bit.ly/1TR34sm. Last accessed November 10, 2016.
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