In recent weeks, two sets of stakeholders have urged the Office of Management and Budget (OMB) to release the Food and Drug Administration’s (FDA) proposed rule on e-labeling, “Electronic Distribution of Prescribing Information of Human Prescription Drugs,” 0910-AG18.  On January 22, 2014, the Biotechnology Industry Organization issued a letter urging OMB and FDA to issue the proposed rule.  Similarly, on February 7, 2014, a bipartisan group of the leaders of the House Energy & Commerce and Senate Health, Education, Labor, & Pensions committees sent a letter to OMB requesting “timely release” of the e-labeling rule.

According to an abstract in HHS’s semiannual regulatory agenda, the proposed e-labeling rule:

would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used.  These inserts contain prescribing information intended for healthcare practitioners.  This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.

79 Fed. Reg. 1158, 1161-62 (Jan. 7, 2014).

Tags: Electronic Labeling
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Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.

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