On the recordMarch 21, 2018
I am opposed to the bill in its current form. The SPEAKER pro tempore. The Clerk will report the motion to recommit. The Clerk read as follows: Mr. Pallone moves to recommit the bill H.R. 5247 to the Committee on Energy and Commerce with instructions to report the same back to the House forthwith, with the following amendment: Strike section 2 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. 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 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.…
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