I 

117TH CONGRESS 

2D SESSION H. R. 6996 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

accelerated approval of a product for a serious or life-threatening disease 

or condition, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 8, 2022 

Mrs. RODGERS of Washington introduced the following bill; which was referred 

to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the accelerated approval of a product for a 

serious or life-threatening disease or condition, and for 

other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Accelerating Access 

5 for Patients Act of 2022’’. 


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1 SEC. 2. ACCELERATED APPROVAL. 

2 (a) IN GENERAL.—Subsection (c) of section 506 of 

3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 356) is amended to read as follows: 

5 ‘‘(c) ACCELERATED APPROVAL OF A DRUG FOR A SE6 RIOUS OR LIFE-THREATENING DISEASE OR CONDITION, 

7 INCLUDING A FAST TRACK PRODUCT.— 

8 ‘‘(1) IN GENERAL.— 

9 ‘‘(A) ACCELERATED APPROVAL.—The Sec10 retary may approve an application for approval 

11 of a product for a serious or life-threatening 

12 disease or condition, including a fast track 

13 product, under section 505(c) of this Act or sec14 tion 351(a) of the Public Health Service Act 

15 upon a determination— 

16 ‘‘(i) that the product has an effect on 

17 a surrogate endpoint that is reasonably 

18 likely to predict clinical benefit, or on a 

19 clinical endpoint that can be measured ear20 lier than irreversible morbidity or mor21 tality, that is reasonably likely to predict 

22 an effect on irreversible morbidity or mor23 tality or other clinical benefit, taking into 

24 account the severity, rarity, or prevalence 

25 of the disease or condition and the avail26 ability or lack of alternative treatments; or 


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1 ‘‘(ii) of the safety and effectiveness of 

2 the product based on the known benefit3 risk profile of such product in the intended 

4 population, taking into account the sever5 ity, rarity, or prevalence of the disease or 

6 condition and the availability or lack of al7 ternative treatments. 

8 ‘‘(B) COMPREHENSIVE CLINICAL DEVEL9 OPMENT PLAN.—The Secretary shall establish 

10 procedures by which a sponsor of a product 

11 seeking approval described in subparagraph (A) 

12 may meet with appropriate officials of the Food 

13 and Drug Administration to develop a plan to 

14 provide clarity and certainty for the sponsor re15 garding the applicability of the requirements of 

16 this subsection. Such a plan shall include— 

17 ‘‘(i) a determination as to whether the 

18 product subject to such approval is in19 tended to treat an unmet medical need; 

20 ‘‘(ii) an agreement on the surrogate 

21 or intermediate clinical endpoint to be as22 sessed, if applicable; 

23 ‘‘(iii) an agreement on the design of 

24 the studies to be conducted to support the 

25 approval; 


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1 ‘‘(iv) a plan for a postapproval study 

2 to satisfy paragraph (2)(A), if required, in3 cluding a plan for reaching agreement on 

4 the design of any such study; 

5 ‘‘(v) a plan for reaching agreement on 

6 the types of developmental milestones to be 

7 met; and 

8 ‘‘(vi) a strategy for the inclusion of di9 verse populations. 

10 ‘‘(C) EVIDENCE.—The evidence to support 

11 that an endpoint is reasonably likely to predict 

12 clinical benefit under subparagraph (A)(i) may 

13 include epidemiological, pathophysiological, 

14 therapeutic, pharmacologic, or other evidence 

15 developed using biomarkers, for example, or 

16 other scientific methods or tools. 

17 ‘‘(D) REFERENCES.—In this section, ap18 proval described in subparagraph (A) is re19 ferred to as ‘accelerated approval’. 

20 ‘‘(2) LIMITATION.—Approval of a product 

21 under this subsection may be subject to 1 or both 

22 of the following requirements: 

23 ‘‘(A) That the sponsor conduct appropriate 

24 postapproval studies (which may include clinical 

25 evidence, patient registries, or other sources of 


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1 real world evidence) to verify and describe the 

2 predicted effect on irreversible morbidity or 

3 mortality or other clinical benefit. 

4 ‘‘(B) That the sponsor submit copies of all 

5 promotional materials related to the product 

6 during the preapproval review period and, fol7 lowing approval and for such period thereafter 

8 as the Secretary determines to be appropriate, 

9 at least 30 days prior to dissemination of the 

10 materials. 

11 ‘‘(3) GUIDANCE.—The Secretary shall issue— 

12 ‘‘(A) guidance describing criteria, proc13 esses, and other general considerations for dem14 onstrating the safety and effectiveness of drugs 

15 submitted for approval described in paragraph 

16 (1)(A)(ii); and 

17 ‘‘(B) guidance on the use of novel clinical 

18 trial designs that may be used to conduct ap19 propriate postapproval studies as may be re20 quired under paragraph (2)(A). 

21 ‘‘(4) APPROVAL OF STUDY PROTOCOL.—Not 

22 later than 60 calendar days after the submission by 

23 the sponsor of a product of a proposed protocol for 

24 a postapproval study required under paragraph 

25 (2)(A), the Secretary shall— 


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1 ‘‘(A) approve the protocol; or 

2 ‘‘(B) specify changes to the protocol that 

3 would enable such approval. 

4 ‘‘(5) EXPEDITED WITHDRAWAL OF AP5 PROVAL.—The Secretary may withdraw approval of 

6 a product approved under accelerated approval using 

7 expedited procedures (as prescribed by the Secretary 

8 in regulations which shall include an opportunity for 

9 an informal hearing) if— 

10 ‘‘(A) the sponsor fails to conduct any re11 quired postapproval study of the product with 

12 due diligence; 

13 ‘‘(B) a study required to verify and de14 scribe the predicted effect on irreversible mor15 bidity or mortality or other clinical benefit of 

16 the product fails to verify and describe such ef17 fect or benefit; 

18 ‘‘(C) other evidence demonstrates that the 

19 product is not safe or effective under the condi20 tions of use; or 

21 ‘‘(D) the sponsor disseminates false or 

22 misleading promotional materials with respect 

23 to the product. 

24 ‘‘(6) REPORTING.—Not later than 180 days 

25 after the date of enactment of the Accelerating AcVerDate Sep 11 2014 18:21 Mar 14, 2022 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H6996.IH H6996

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1 cess for Patients Act of 2022, and annually there2 after, the Secretary shall submit to the Committee 

3 on Energy and Commerce of the House of Rep4 resentatives and the Committee on Health, Edu5 cation, Labor, and Pensions of the Senate a report 

6 describing— 

7 ‘‘(A) the circumstances and number of ap8 plications submitted for approval described in 

9 paragraph (1)(A) for which real world evidence 

10 was deemed appropriate to support or fulfill 

11 postapproval studies required under this sub12 section; and 

13 ‘‘(B) the circumstances and number of ap14 plications submitted for approval described in 

15 paragraph (1)(A) for which real world evidence 

16 was submitted for such postapproval studies.’’. 

17 (b) INITIAL GUIDANCE.—The Secretary of Health 

18 and Human Services, acting through the Commissioner of 

19 Food and Drugs— 

20 (1) shall issue draft guidance pursuant to sec21 tion 506(c)(3) of the Federal Food, Drug, and Cos22 metic Act, as amended by subsection (a), not later 

23 than 18 months after the date of enactment of this 

24 Act; 


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1 (2) shall promulgate final guidance pursuant to 

2 such section 506(c)(3) not later than 18 months 

3 after the close of the public comment period on such 

4 draft guidance; and 

5 (3) may approve products as described in sec6 tion 506(c)(1)(A) of the Federal Food, Drug, and 

7 Cosmetic Act, as amended by subsection (a), prior to 

8 issuing initial draft or final guidance under this sub9 section. 

Æ 


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