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).