Adopting a Hands-On Approach to Patient Labeling


Erik Swain

Pharmaceutical companies should rethink their hands-off attitudes toward the information provided on patient labeling for prescription drugs, a healthcare attorney told industry representatives at a recent conference.

Except for a few products specifically designated by FDA, drug companies are not required to provide information directly to the patients on the package inserts they receive with their prescription drugs. Rather, the content of the insert the patient receives is likely to have been written by the firms that provide software systems for pharmacies.

Gregory M. Fisher, Esq., an attorney at Royer & Babyak (Washington, DC), said most of the people he knows who work for prescription drug manufacturers have told him that their firms prefer not to get involved with patient labeling, for fear of providing an opening to be sued on a product liability claim. Fisher was also the former associate general counsel for the Consumer Healthcare Products Association (Washington, DC).

At the Center for Business Intelligence's (Woburn, MA) conference on pharmaceutical promotional labeling, held February 28 and March 1 in Atlantic City, NJ, Fisher told the audience the reality of the matter is that if a product liability issue occurs, the drug company is very likely to get sued. The reason, he said, is that even if the issue resulted from something on the patient insert and the drug company had nothing to do with writing it, plaintiffs' attorneys will go after the drug company because it has deeper pockets than the software provider and might be more likely to settle the case than fight it out in court.

"You're subject to liability anyway, so why not take the initiative; call the software providers and tell them what they're missing," Fisher said. "This [hands-off] stance is not consistent with the information age, where you are expected to provide patients with more information—not less."

Now that FDA has clarified how drug companies should communicate with patients in direct-to-consumer advertising, maybe drug firms should use those requirements as a guide to providing better patient labeling, he said.

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