1. 17. 62 Fed. Reg. 61710 (Nov. 19, 1997); see also Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 18 (2017) (statement of Janet Woodcock, Director, Center for Drug Evaluation and Research); see also FDA, “Rulemaking History for OTC External Analgesic Drug Prod-ucts,” available at (last visited May 6, 2021).
2. 15. 44 Fed. Reg. 69768 (Dec. 4, 1979); see also FDA, “Rulemaking History for OTC External Analgesic Drug Prod-ucts,” available at (last visited May 6, 2021).
3. 31. 21 U.S.C. § 355h(b)(2)-(3).
4. 20. See D. C. Spangler and R. Rathore, supra note 19.
5. 43. Hilzenrath, D. S. , “Coronavirus Relief Act Gives Drug Makers New Sway over FDA,” Project on Gov’t Oversight, May 5, 2020, available at (last visited May 6, 2021).