IB 

Union Calendar No. 63 

114TH CONGRESS 

1ST SESSION H. R. 471 

[Report No. 114–85, Part I] 

To improve enforcement efforts related to prescription drug diversion and 

abuse, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 22, 2015 

Mr. MARINO (for himself, Mr. WELCH, Mrs. BLACKBURN, and Ms. CHU of 

California) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

the Judiciary, for a period to be subsequently determined by the Speaker, 

in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

APRIL 20, 2015 

Additional sponsors: Mr. COLLINS of Georgia, Mr. BILIRAKIS, and Mr. 

COSTELLO of Pennsylvania 

APRIL 20, 2015 

Reported from the Committee on Energy and Commerce 

APRIL 20, 2015 

The Committee on the Judiciary discharged; committed to the Committee of 

the Whole House on the State of the Union and ordered to be printed 


asabaliauskas on DSK5VPTVN1PROD with BILLS
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•HR 471 RH

A BILL 

To improve enforcement efforts related to prescription drug 

diversion and abuse, and for other purposes. 


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•HR 471 RH

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 ‘‘Ensuring Patient Ac5 cess and Effective Drug Enforcement Act of 2015’’. 

6 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 

7 SUBSTANCES ACT. 

8 (a) DEFINITIONS.— 

9 (1) FACTORS AS MAY BE RELEVANT TO AND

10 CONSISTENT WITH THE PUBLIC HEALTH AND SAFE11 TY.—Section 303 of the Controlled Substances Act 

12 (21 U.S.C. 823) is amended by adding at the end 

13 the following: 

14 ‘‘(i) In this section, the phrase ‘factors as may be rel15 evant to and consistent with the public health and safety’ 

16 means factors that are relevant to and consistent with the 

17 findings contained in section 101.’’. 

18 (2) IMMINENT DANGER TO THE PUBLIC

19 HEALTH OR SAFETY.—Section 304(d) of the Con20 trolled Substances Act (21 U.S.C. 824(d)) is amend21 ed— 

22 (A) by striking ‘‘(d) The Attorney Gen23 eral’’ and inserting ‘‘(d)(1) The Attorney Gen24 eral’’; and 

25 (B) by adding at the end the following: 


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1 ‘‘(2) In this subsection, the phrase ‘imminent danger 

2 to the public health or safety’ means that, in the absence 

3 of an immediate suspension order, controlled substances— 

4 ‘‘(A) will continue to be intentionally distrib5 uted or dispensed— 

6 ‘‘(i) outside the usual course of profes7 sional practice; or 

8 ‘‘(ii) in a manner that poses a present or 

9 foreseeable risk of serious adverse health con10 sequences or death; or 

11 ‘‘(B) will continue to be intentionally diverted 

12 outside of legitimate distribution channels.’’. 

13 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

14 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Sub15 section (c) of section 304 of the Controlled Substances Act 

16 (21 U.S.C. 824) is amended— 

17 (1) by striking the last two sentences in such 

18 subsection; 

19 (2) by striking ‘‘(c) Before’’ and inserting 

20 ‘‘(c)(1) Before’’; and 

21 (3) by adding at the end the following: 

22 ‘‘(2) An order to show cause under paragraph (1) 

23 shall— 

24 ‘‘(A) contain a statement of the basis for the 

25 denial, revocation, or suspension, including specific 


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1 citations to any laws or regulations alleged to be vio2 lated by the applicant or registrant; 

3 ‘‘(B) direct the applicant or registrant to ap4 pear before the Attorney General at a time and 

5 place stated in the order, but no less than thirty 

6 days after the date of receipt of the order; and 

7 ‘‘(C) notify the applicant or registrant of the 

8 opportunity to submit a corrective action plan on or 

9 before the date of appearance. 

10 ‘‘(3) Upon review of any corrective action plan sub11 mitted by an applicant or registrant pursuant to para12 graph (2), the Attorney General shall determine whether 

13 denial, revocation or suspension proceedings should be dis14 continued, or deferred for the purposes of modification, 

15 amendment, or clarification to such plan. 

16 ‘‘(4) Proceedings to deny, revoke, or suspend shall 

17 be conducted pursuant to this section in accordance with 

18 subchapter II of chapter 5 of title 5. Such proceedings 

19 shall be independent of, and not in lieu of, criminal pros20 ecutions or other proceedings under this title or any other 

21 law of the United States. 

22 ‘‘(5) The requirements of this subsection shall not 

23 apply to the issuance of an immediate suspension order 

24 under subsection (d).’’. 


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1 SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN2 FORCEMENT ACTIVITIES ON PATIENT AC3 CESS TO MEDICATIONS. 

4 (a) IN GENERAL.—Not later than one year after the 

5 date of enactment of this Act, the Secretary of Health and 

6 Human Services, acting through the Commissioner of 

7 Food and Drugs and the Director of the Centers for Dis8 ease Control and Prevention, and in consultation with the 

9 Administrator of the Drug Enforcement Administration 

10 and the Director of National Drug Control Policy, shall 

11 submit a report to the Committee on the Judiciary of the 

12 House of Representatives, the Committee on Energy and 

13 Commerce of the House of Representatives, the Com14 mittee on the Judiciary of the Senate, and the Committee 

15 on Health, Education, Labor, and Pensions of the Senate 

16 identifying— 

17 (1) obstacles to legitimate patient access to con18 trolled substances; 

19 (2) issues with diversion of controlled sub20 stances; and 

21 (3) how collaboration between Federal, State, 

22 local, and tribal law enforcement agencies and the 

23 pharmaceutical industry can benefit patients and 

24 prevent diversion and abuse of controlled substances. 


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1 (b) CONSULTATION.—The report under subsection 

2 (a) shall incorporate feedback and recommendations from 

3 the following: 

4 (1) Patient groups. 

5 (2) Pharmacies. 

6 (3) Drug manufacturers. 

7 (4) Common or contract carriers and ware8 housemen. 

9 (5) Hospitals, physicians, and other health care 

10 providers. 

11 (6) State attorneys general. 

12 (7) Federal, State, local, and tribal law enforce13 ment agencies. 

14 (8) Health insurance providers and entities that 

15 provide pharmacy benefit management services on 

16 behalf of a health insurance provider. 

17 (9) Wholesale drug distributors. 


asabaliauskas on DSK5VPTVN1PROD with BILLS
Union Calendar No. 63 

114TH CONGRESS 

1ST SESSION H. R. 471 

[Report No. 114–85, Part I] 

A BILL 

To improve enforcement efforts related to prescripposes. tion drug diversion and abuse, and for other purAPRIL 20, 2015 

Reported from the Committee on Energy and Commerce 

APRIL 20, 2015 

The Committee on the Judiciary discharged; committed 

the Union and ordered to be printed to the Committee of the Whole House on the State of 


asabaliauskas on DSK5VPTVN1PROD with BILLS