Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/3



Congress delegated to the Food and Drug Administration (“FDA”) the responsibility to ensure that “new drugs” are “safe and effective.” 21 U.S.C. §§ 321(p), 355; see also id. § 393(b)(2)(B). When making its approval determination, FDA evaluates whether a new drug application (“NDA”) includes scientific evidence demonstrating that the drug is safe and effective for its intended uses. Id. § 355(d); see also 21 C.F.R. §§ 314.50, 314.105(c). Similarly, when a sponsor submits a supplemental new drug application (“SNDA”) proposing changes to the conditions of approval for a drug (such as changes to a drug’s labeling or FDA-imposed restrictions), FDA reviews the scientific evidence to support the changes. See 21 C.F.R. § 314.70. To approve a generic version of a previously approved drug, FDA reviews whether an abbreviated new drug application (“ANDA”) contains information showing that the proposed generic drug is materially the “same” as the approved drug. 21 U.S.C. § 355(j)(2).

In 1992, FDA promulgated the so-called “Subpart H” regulations. Subpart H accelerates approval of drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).” 21 C.F.R. § 314.500. Originally, Subpart H was intended to promote rapid approval for life-saving HIV-AIDS drugs. But given that Subpart H approvals were accelerated, FDA recognized that it would need post-approval safety measures. These post-approval safety measures would “assure safe use” of the quickly approved Subpart H drugs. Id. § 314.520. In 2007, Congress ratified these post-approval safety measures as “risk evaluation and