How HR 5632 changes current law

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill establishes additional procedures for FDA approval of opioid drugs that go against advisory committee recommendations and requires reporting to Congress.

• 21 U.S.C. 355(b)

  and shall not be delegated.

  This change mandates that only the Commissioner of Food and Drugs can approve applications for opioid drugs against advisory committee recommendations.

• 21 U.S.C. 355(b)

  A drug approved as described in subsection (a) shall not be introduced or delivered for introduction into interstate commerce until the report described in subsection (b)(1) has been submitted to Congress.

  This establishes that an opioid drug approved against advisory recommendations cannot be marketed until required reports are submitted to Congress.

• Public Law 114-198, Section 106(a)(1)(A)

  application → application, or supplement to an application,

  This allows the advisory committee's review to encompass supplements to applications, broadening its scope.

• Public Law 114-198, Section 106(a)(1)(A)

  of a new → for

  This clarifies the language regarding the review process of applications by the advisory committee.