Right to Test Act

II 116TH CONGRESS 2D SESSION S. 3769 To allow States to approve the use of diagnostic tests during a public health emergency. IN THE SENATE OF THE UNITED STATES MAY 19, 2020 Mr. CRUZ (for himself, Mr. BRAUN, Mrs. LOEFFLER, and Mr. LEE) intro- duced the following bill; which was read twice and referred to the Com- mittee on Health, Education, Labor, and Pensions A BILL To allow States to approve the use of diagnostic tests during a public health emergency. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Right to Test Act’’. 4 SEC. 2. STATE APPROVAL OF DIAGNOSTIC TESTS. 5 (a) IN GENERAL.—Notwithstanding chapter V of the 6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 7 et seq.) and section 353 of the Public Health Service Act 8 (42 U.S.C. 263a), during any public health emergency de- 9 clared by the Secretary of Health and Human Services 10 VerDate Sep 11 2014 01:18 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3769.IS S3769 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 3769 IS (referred to in this section as the ‘‘Secretary’’) under sec- 1 tion 319 of the Public Health Service Act (42 U.S.C. 2 247d) or by a State in accordance with the law of the 3 State, the public health department of such State (or such 4 other State entity as designated by the governor of the 5 State) may clear or approve diagnostic tests or diagnostic 6 devices, for use in that State during the applicable public 7 health emergency only. 8 (b) APPLICATION.—An approval or clearance pursu- 9 ant to subsection (a) may— 10 (1) allow for the preparation, compounding, as- 11 sembly, propagation, manufacture, development, 12 sale, distribution, or use of a specified diagnostic 13 test or diagnostic device to address the health diag- 14 nostic needs of the State during the public health 15 emergency; 16 (2) apply to a diagnostic test or diagnostic de- 17 vice needed to address the health diagnostic needs of 18 the State during the public health emergency, as de- 19 termined by the State, including, but not limited to, 20 a test or device that uses reagents or swabbing (in- 21 cluding self-swab); 22 (3) apply to the testing of patients if the State 23 certifies that the test can be validated, as deter- 24 mined by the State; and 25 VerDate Sep 11 2014 01:18 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3769.IS S3769 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 3769 IS (4) apply to laboratory-developed tests per- 1 formed by laboratories and hospitals certified under 2 section 353 of the Public Health Service Act (42 3 U.S.C. 263a), and to such tests performed by clin- 4 ical laboratory companies. 5 (c) SUSPENSION ENFORCEMENT BY FDA.— 6 (1) IN GENERAL.—Except as provided in para- 7 graph (1), with respect to a diagnostic test or diag- 8 nostic device approved or cleared by a State pursu- 9 ant to subsection (a), the Secretary may not, for the 10 duration of the applicable public health emergency 11 engage in any enforcement action— 12 (A) with respect to the test or device, to 13 the extent that such test or device is distributed 14 and used within the State granting the approval 15 or clearance in accordance with the require- 16 ments of the State; 17 (B) against a State or State entity that 18 clears or approves the test or device in accord- 19 ance with this section; or 20 (C) against any State, entity of a State, 21 health care provider, health care facility, labora- 22 tory, educational institution, manufacturer, or 23 distributor that prepares, propagates, com- 24 pounds, assembles, or processes a diagnostic 25 VerDate Sep 11 2014 01:18 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3769.IS S3769 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 3769 IS test or diagnostic device by chemical, physical, 1 biological, or other procedure for such test or 2 device or develops, manufactures, distributes, 3 sells, administers, or evaluates such test— 4 (i) within the applicable State in ac- 5 cordance with the requirements of the 6 State; or 7 (ii) for the applicable State or individ- 8 uals or entities that are located within the 9 applicable State. 10 (2) EXCEPTION.—The provisions of paragraph 11 (1) shall not apply with respect to a State if the gov- 12 ernor of the State requests that enforcement con- 13 tinue in the State during the public health emer- 14 gency. 15 (d) ACTION BY FDA AFTER PUBLIC HEALTH EMER- 16 GENCY.—Not later than 180 days after the end of any 17 public health emergency under which a State exercises its 18 authority under subsection (a) with respect to a diagnostic 19 test or diagnostic device, if the Food and Drug Adminis- 20 tration has not cleared or approved such test or device 21 under chapter V of the Federal Food, Drug, and Cosmetic 22 Act, the Secretary shall review and make a final deter- 23 mination, within such 180-day period, with respect to such 24 test or device for clearance or approval. 25 VerDate Sep 11 2014 01:18 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3769.IS S3769 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 3769 IS (e) DIAGNOSTIC TESTS AND DIAGNOSTIC DE- 1 VICES.—In this section, the terms ‘‘diagnostic test’’ and 2 ‘‘diagnostic device’’ include in vitro diagnostic products, 3 laboratory developed tests, viral tests, serological and anti- 4 body tests, and any other test used to identify, analyze, 5 or investigate a disease. 6 Æ VerDate Sep 11 2014 01:18 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S3769.IS S3769 pbinns on DSKJLVW7X2PROD with BILLS