A three-judge panel of the U.S. Court of Appeals for the 2nd Circuit said Vermont’s law that restricts companies' use of information about the drugs doctors prescribe is unconstitutional on free speech grounds.
In a 2-1 ruling, the New York appeals court said the law doesn't achieve what Vermont wants to achieve and that a more limited restriction would be better.
"The state has not demonstrated that its interests in protecting public health and containing health care costs could not be as well served by a more limited restriction on speech," the majority opinion said.
But there’s more to this issue than Free Speech. There’s also a crucial safety component.
When FDA-directed safety warnings are issued, they're communicated via "Dear Doctor" letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans - developed for physicians who prescribe higher-risk therapies - are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), "Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others."
Relative to physician concern that their prescribing data will be used for aggressive marketing campaigns, the AMA has a web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing-data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA's program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
