On October 14, 2022, President Joe Biden signed Executive Order 14036, directing the Department of Health and Human Services (“HHS”) to consider innovative actions to drive down certain single-source prescription drug costs as the Biden-Harris Administration works to implement the Inflation Reduction Act of 2022 (the “Act”).

On June 27, 2022, the United States Supreme Court, by a vote of 9-0, overturned the lower circuit courts’ rulings affirming the convictions of two physicians of the unlawful distribution of controlled substances. In Ruan v. United States (Case No. 20-1410), consolidated with Kahn v. United States (Case No. 21-5261), the Supreme Court was asked to determine whether a physician may be convicted of unlawful distribution of controlled substances under 21 U.S.C. § 841(a)(1) without regard to whether, in good faith, the physician “reasonably believed” or “subjectively intended” that his or her prescriptions fall within that course of professional practice. The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “except as authorized.” A prescription is authorized when it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). The “vague and highly general regulatory language” left open the question of what conduct would fall under the statute’s exception and thus be considered legal.