I 118TH CONGRESS 1ST SESSION H. R. 3008 To amend the Federal Food, Drug, and Cosmetic Act to provide for notifica- tion by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. IN THE HOUSE OF REPRESENTATIVES APRIL 28, 2023 Ms. JACOBS (for herself, Mr. ALLRED, Ms. CLARKE of New York, Mr. DOG- GETT, Mr. GARCI´A of Illinois, Mr. GRIJALVA, Mr. HUFFMAN, Mr. KHANNA, Mr. LARSON of Connecticut, Ms. LEE of California, Mr. MCGOVERN, Ms. OCASIO-CORTEZ, Ms. PRESSLEY, Mr. VEASEY, Ms. VELA´ZQUEZ, Mrs. WATSON COLEMAN, Mr. CARTER of Louisiana, Ms. NORTON, Mr. COHEN, Mr. CLEAVER, Mr. SMITH of Washington, Ms. BLUNT ROCHESTER, Ms. CROCKETT, Ms. KUSTER, Ms. TOKUDA, Ms. CARAVEO, Mr. SCHIFF, Ms. JACKSON LEE, Mr. KIM of New Jersey, and Mr. MILLS) introduced the following bill; which was referred to the Com- mittee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical es- sential medicines of increased demand of such drugs, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3008 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Drug Shortage Preven- 2 tion Act of 2023’’. 3 SEC. 2. IMPROVING NOTIFICATION PROCEDURES IN CASE 4 OF INCREASED DEMAND FOR CRITICAL ES- 5 SENTIAL MEDICINES. 6 (a) IN GENERAL.—Section 506C of the Federal 7 Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amend- 8 ed— 9 (1) in the section heading, by striking ‘‘DIS- 10 CONTINUANCE OR INTERRUPTION IN THE PRO- 11 DUCTION OF LIFE-SAVING DRUGS’’ and inserting 12 ‘‘NOTIFICATION OF ISSUES AFFECTING DOMES- 13 TIC SUPPLY OF CRITICAL ESSENTIAL MEDI- 14 CINES’’; 15 (2) by striking subsections (a), (b), and (c), and 16 inserting the following: 17 ‘‘(a) NOTIFICATION REQUIRED.— 18 ‘‘(1) IN GENERAL.—A manufacturer of a crit- 19 ical essential medicine shall notify the Secretary, in 20 accordance with subsection (b), of— 21 ‘‘(A)(i) a permanent discontinuance in the 22 manufacture of the drug or an interruption of 23 the manufacture of the drug that is likely to 24 lead to a meaningful disruption in the supply of 25 such drug in the United States; 26 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 3008 IH ‘‘(ii) a permanent discontinuance in the 1 manufacture of an active pharmaceutical ingre- 2 dient, an excipient, or any other input in the 3 final dosage form of such drug or an interrup- 4 tion in the manufacture of the active pharma- 5 ceutical ingredient, an excipient, or any other 6 input in the final dosage form of such drug of 7 such drug that is likely to lead to a meaningful 8 disruption in the supply of the active pharma- 9 ceutical ingredient of such drug; 10 ‘‘(iii) an increased demand (other than an 11 anticipated seasonal surge) for such drug or an 12 active pharmaceutical ingredient, an excipient, 13 or any other input in the final dosage form of 14 such drug that is likely to lead to a shortage of 15 the drug or the active pharmaceutical ingre- 16 dient, an excipient, or any other input in the 17 final dosage form of such drug; and 18 ‘‘(B) the reasons for such discontinuance, 19 interruption, or increased demand. 20 ‘‘(2) CONTENTS.—Notification under this sub- 21 section with respect to a critical essential medicine 22 shall include— 23 ‘‘(A) with respect to the reasons for the 24 discontinuation, interruption, or increased de- 25 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 3008 IH mand referred to in paragraph (1)(C), if an ac- 1 tive pharmaceutical ingredient, an excipient, or 2 any other input in the final dosage form of such 3 drug is a reason for, or risk factor in, such dis- 4 continuation, interruption, or increased de- 5 mand, the source of the active pharmaceutical 6 ingredient, excipient, or other input and any al- 7 ternative sources for the an active pharma- 8 ceutical ingredient, an excipient, or any other 9 input by the manufacturer; 10 ‘‘(B) whether any associated device used 11 for preparation or administration included in 12 the drug is a reason for, or a risk factor in, 13 such discontinuation, interruption, or increased 14 demand; 15 ‘‘(C) the expected duration of the interrup- 16 tion or increased demand; and 17 ‘‘(D) such other information as the Sec- 18 retary may require. 19 ‘‘(b) TIMING.— 20 ‘‘(1) IN GENERAL.—A notice required under 21 subsection (a) shall be submitted to the Secretary— 22 ‘‘(A) at least 6 months prior to the date of 23 the discontinuance or interruption; 24 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 3008 IH ‘‘(B) in the case of such a notice with re- 1 spect to increased demand for a critical essen- 2 tial medicine, not later than 30 days after the 3 submission of the initial notification under 4 paragraph (2); or 5 ‘‘(C) if compliance with subparagraph (A) 6 or (B) is not possible, as soon as practicable. 7 ‘‘(2) INITIAL NOTIFICATION WITH RESPECT TO 8 INCREASED DEMAND.—In the case a notification re- 9 quired under subsection (a) with respect to increased 10 demand for a critical essential medicine, the manu- 11 facturer of the drug involved shall submit to the 12 Secretary an initial notification not later than 48 13 hours after the date on which there has been in- 14 creased demand for the critical essential medicine 15 for a period of at least 6 consecutive weeks. 16 ‘‘(c) DISTRIBUTION.—To the maximum extent prac- 17 ticable, the Secretary shall distribute, through such means 18 as the Secretary deems appropriate, information on the 19 discontinuance or interruption of the manufacture of, or 20 the increased demand for, critical essential medicines to 21 appropriate organizations, including physician, health pro- 22 vider, and patient organizations, as described in section 23 506E.’’; 24 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 3008 IH (3) in subsection (g), in the matter preceding 1 paragraph (1), by striking ‘‘drug described in sub- 2 section (a)’’ and inserting ‘‘critical essential medi- 3 cine’’; and 4 (4) in subsection (j), by striking ‘‘drug de- 5 scribed in subsection (a)’’ and inserting ‘‘critical es- 6 sential medicine’’. 7 (b) APPLICATION TO NONPRESCRIPTION DRUGS.— 8 Section 506C(h) of the Federal Food, Drug, and Cosmetic 9 Act (21 U.S.C. 356c(h)) is amended— 10 (1) by redesignating paragraphs (1), (2), and 11 (3) as paragraphs (2), (3), and (4), respectively; 12 (2) in paragraph (2)(A) (as so redesignated), by 13 striking ‘‘and that is subject to section 503(b)(1)’’ 14 and inserting ‘‘, including a drug that is not subject 15 to section 503(b)(1)’’; and 16 (3) by inserting before paragraph (2) (as so re- 17 designated) the following: 18 ‘‘(1) the term ‘critical essential medicine’ means 19 a drug that— 20 ‘‘(A) is— 21 ‘‘(i) life-supporting; 22 ‘‘(ii) life-sustaining; or 23 ‘‘(iii) intended for use in the preven- 24 tion or treatment of a debilitating disease 25 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 3008 IH or condition, including any such drug used 1 in emergency medical care or during sur- 2 gery or any such drug that is critical to 3 the public health during a public health 4 emergency declared by the Secretary under 5 section 319 of the Public Health Service 6 Act; and 7 ‘‘(B) is not a radio pharmaceutical drug 8 product or any other product as designated by 9 the Secretary;’’. 10 (c) REGULATIONS.—Not later than 18 months after 11 the date of the enactment of this Act, the Secretary of 12 Health and Human Services shall issue final regulations 13 to implement the amendments made by subsections (a) 14 and (b). 15 (d) GUIDANCE.— 16 (1) IN GENERAL.—The Secretary of Health and 17 Human Services, acting through the Commissioner 18 of Food and Drugs, shall issue guidance on the re- 19 quirements for notifications required to be submitted 20 under section 506C of the Federal Food, Drug, and 21 Cosmetic Act (21 U.S.C. 356c), as amended by sub- 22 sections (a) and (b), with respect to increased de- 23 mand for critical essential medicines (as defined in 24 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 3008 IH such section 506C). Such guidance shall specifically 1 address— 2 (A) the ways in which manufacturers of 3 critical essential medicines can improve demand 4 predictability; 5 (B) what information manufacturers of 6 critical essential medicines should send to the 7 Secretary; and 8 (C) what communications from the manu- 9 facturer the Secretary would request with re- 10 spect to increases in demand following such no- 11 tifications. 12 (2) CONSULTATION.—In developing such guid- 13 ance, the Secretary shall consult with relevant stake- 14 holders, including manufacturers of critical essential 15 medicines and local, State, or Federal public health 16 officials. 17 (3) TIMING.—The Secretary of Health and 18 Human Services, acting through the Commissioner 19 of Food and Drugs, shall issue— 20 (A) draft guidance under paragraph (1) 21 not later than 120 days after the date of the 22 enactment of this Act; and 23 VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •HR 3008 IH (B) final guidance under such paragraph 1 not later than 180 days after the date of the 2 enactment of this Act. 3 Æ VerDate Sep 11 2014 04:49 May 11, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H3008.IH H3008 pbinns on DSKJLVW7X2PROD with $$_JOB