Expedited Review of New Drugs

To the Editor: Mr Moore and Dr Furberg¹ stated that “the US Senate, in approving a regular 5-year update to the Food, Drug, and Cosmetic Act, proposed a further expansion of expedited review, with a new category for ‘breakthrough drugs.’” They also expressed concerns about “ . . . complex safety issues raised by the expedited approval pathway.” The US Food and Drug Administration (FDA) Amendments Act of 2007 expanded the agency's authority regarding drug safety. Under this act, the FDA may require a risk evaluation and mitigation strategy to manage a known or potential serious risk associated with a drug or biological product,² as well as a postmarketing requirement at the time of product approval, or after approval, if the FDA becomes aware of new safety information.³ Postmarketing studies may be required to assess a known serious risk related to the use of the product, to assess signals of serious risk related to the use of the product, or to identify an unexpected serious risk when available data indicate the potential for a serious risk.³ Comprehensive safety evaluations are performed 18 months after approval of a new drug or biological product.⁴ Since 2008, biweekly screening of the FDA Adverse Event Reporting System has identified 210 potential signals of serious risks or new safety information.⁵ In their discussion of safety concerns associated with dabigatran, Moore and Furberg neglected to point out that 2 of these potential signals pertain to that drug.⁵