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Sarah E. Coyne quoted in article “Life Sciences Regulation And Legislation To Watch In 2014: A New World for Off-Label Marketing”


Following is an excerpt: 

Recent directives by the U.S. Food and Drug Administration, federal courts and Congress will drive some big regulatory shifts in the life sciences field in 2014, with attorneys watching especially the implementation of the newly passed Drug Quality and Security Act and the regulation of direct-to-consumer marketing.

The agency would likely try to skirt tricky First Amendment issues by attempting to restrict conduct as opposed to speech, according to Roger Morris of Quarles & Brady LLP.

The agency could restrict pharmaceutical firms from issuing certain marketing materials, including studies published in credible journals such as The Journal of the American Medical Association, which they are currently allowed to issue to health care providers who request them.

The Health Information Technology for Economic and Clinical Health Act, part of the American Recovery and Reinvestment Act of 2009, expanded the tracking obligation by requiring regulated entities including health care providers, and their business associates, to account for disclosures from electronic health records for treatment, payment or health care operations. This would essentially give patients who ask a list of individuals who have accessed their electronic health records, according to Sarah Coyne of Quarles & Brady LLP.

The proposed HIPAA rule on accounting of disclosures from an electronic health record, which was announced in May 2011, has not yet been finalized, she noted. Life sciences firms should be especially conscious about making disclosures through mobile apps, as they could be swept into HIPAA oversight as business associates of health providers, she said.

"Once the HIPAA final accounting rule comes out, providers and business associates will need to keep track of disclosures from a patient's electronic health record for treatment, payment or health care operations," Coyne said. "There wasn’t a lot of definition in the proposed rule as to how to implement this requirement and it has caused a lot of anxiety for providers, especially where their electronic medical record vendors have not implemented a technological solution for the required accounting."

The DQSA also includes a track-and-trace system for prescription drugs, which creates a new, nationwide framework for tracking drugs from production through their receipt by pharmacies.

This is also an area ripe for additional regulatory guidance, particularly with respect to combination drug and medical device products, according to Morris, who said there is some confusion about whether devices accompanying a particular drug would be subject to the same tracing requirements.

Originally published in Law360, January 1, 2014