What new off-label drug laws could mean for pharma marketers

When the U.S. Food and Drug Administration approves a new pharmaceutical product, it does not allow manufacturers to market the product for ailments other than those listed on the label. Though it isn't illegal to prescribe medications for other ailments, that decision is typically made by a physician.

A new law in Arizona is changing that, and it could alter the landscape for pharma marketers in the Copper State.

Arizona the first state to pass an off-label drug law

Earlier this year, Arizona became the first state to allow drug makers to advertise their products for off-label uses. According to the law, pharmaceutical manufacturers may engage in the truthful promotion of off-label use.

The new law was devised by libertarian think tank, the Goldwater Institute. Naomi Lopez Bauman, the director of healthcare policy at the organization, told the Stateline, a division of The Pew Charitable Trusts, that she anticipates the bill to arrive at other states in the coming months, though she was unable to say which the group expects to target next.

Since the law is relatively recent, there isn't much data about the effects it has had on Arizona's healthcare system. However, there's little doubt that pharmaceutical companies across the country will be keeping a close eye on the state, as well as dipping in their toes to test the water.

Opponents of the new law worry that off-label use will risk patient safety. Supporters of the law point to the fact that prescribing drugs for non-FDA approved uses isn't illegal and already a commonplace practice.

For example, researchers at the University of Chicago found that, for 10 commonly used oncology medications, 30 percent of prescriptions were for off-label uses. Another study from the University of Kentucky found similar results – 65 percent of the most commonly prescribed pediatric antipsychotic medications had been prescribed for off-label uses.

The new law allows pharma manufacturers to market their products for non-FDA approved uses.

Why this matters for pharmaceutical marketers

This new law could mean that pharma manufacturers could boost sales among patient populations that wouldn't have considered their products previously. Of course, manufacturer representatives will still have to convince physicians that their products are safe for those new uses.

Deregulation of pharma marketing could have a big impact on drug spending in Arizona, which is home to over 1 million Medicare beneficiaries, according to eHealth Medicare. The state has a high senior population, with 15.9 percent of residents over the age of 65.

In other words, there's a huge potential for pharma manufacturers to reach a significantly large population of patients who, on average, have a greater need for medications, compared to younger cohorts.

Keeping patient safety at the forefront

The biggest concern for all involved parties should be the safety of patients. As the new law states, manufacturers are expected to remain truthful in their promotions. Marketers should expect a lot of questions from physicians, and they should be prepared to verify the safety of their products for off-label uses.

Other states will be watching Arizona to see how the new law impacts drug sales and patient health. Until more time has passed, pharma marketers should likewise keep their eye on drug sales in Arizona, comparing metrics with other markets.

One thing is for sure, pharma marketers will need to use targeted advertising methods to get their new messages in front of physicians, and there are few channels more highly defined that peer-reviewed medical journals.

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