Janice Schakowsky: “I am opposed in its current form. The SPEAKER pro tempore. The Clerk will report the motion to recommit. The Clerk read…”

“I am opposed in its current form. The SPEAKER pro tempore. The Clerk will report the motion to recommit. The Clerk read as follows: Ms. Schakowsky moves to recommit the bill S. 204 to the Committee on Energy and Commerce with instructions to report the same back to the House forthwith, with the following amendment: Strike all after section 1 and insert the following: SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS DIAGNOSED WITH A TERMINAL ILLNESS. (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A (21 U.S.C. 360bbb-0) the following: ``SEC. 561B. ELIGIBLE INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE PATIENTS. ``(a) Use of Clinical Outcomes.-- ``(1) In general.--The Secretary shall issue guidance describing the Secretary's consideration and evaluation, for purposes of the review of, and decision on whether to approve, a marketing application under section 505 of this Act or section 351 of the Public Health Service Act for an eligible investigational drug, of clinical outcomes associated with the provision by a sponsor or manufacturer of such drug under subsection (b) or (c) of section 561.…”