I 

114TH CONGRESS 

1ST SESSION H. R. 471 

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 

A BILL 

To improve enforcement efforts related to prescription drug 

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

6 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 

7 SUBSTANCES ACT. 

8 (a) DEFINITIONS.— 


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1 (1) FACTORS AS MAY BE RELEVANT TO AND

2 CONSISTENT WITH THE PUBLIC HEALTH AND SAFE3 TY.—Section 303 of the Controlled Substances Act 

4 (21 U.S.C. 823) is amended by adding at the end 

5 the following: 

6 ‘‘(i) In this section, the phrase ‘factors as may be rel7 evant to and consistent with the public health and safety’ 

8 means factors that are relevant to and consistent with the 

9 findings contained in section 101.’’. 

10 (2) IMMINENT DANGER TO THE PUBLIC

11 HEALTH OR SAFETY.—Section 304(d) of the Con12 trolled Substances Act (21 U.S.C. 824(d)) is amend13 ed— 

14 (A) by striking ‘‘(d) The Attorney Gen15 eral’’ and inserting ‘‘(d)(1) The Attorney Gen16 eral’’; and 

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

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

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

20 of an immediate suspension order, controlled substances— 

21 ‘‘(A) will continue to be intentionally distrib22 uted or dispensed— 

23 ‘‘(i) outside the usual course of profes24 sional practice; or 


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

2 foreseeable risk of serious adverse health con3 sequences or death; or 

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

5 outside of legitimate distribution channels.’’. 

6 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

7 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Sub8 section (c) of section 304 of the Controlled Substances Act 

9 (21 U.S.C. 824) is amended— 

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

11 subsection; 

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

13 ‘‘(c)(1) Before’’; and 

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

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

16 shall— 

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

18 denial, revocation, or suspension, including specific 

19 citations to any laws or regulations alleged to be vio20 lated by the applicant or registrant; 

21 ‘‘(B) direct the applicant or registrant to ap22 pear before the Attorney General at a time and 

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

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


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

2 opportunity to submit a corrective action plan on or 

3 before the date of appearance. 

4 ‘‘(3) Upon review of any corrective action plan sub5 mitted by an applicant or registrant pursuant to para6 graph (2), the Attorney General shall determine whether 

7 denial, revocation or suspension proceedings should be dis8 continued, or deferred for the purposes of modification, 

9 amendment, or clarification to such plan. 

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

11 be conducted pursuant to this section in accordance with 

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

13 shall be independent of, and not in lieu of, criminal pros14 ecutions or other proceedings under this title or any other 

15 law of the United States. 

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

17 apply to the issuance of an immediate suspension order 

18 under subsection (d).’’. 

19 SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN20 FORCEMENT ACTIVITIES ON PATIENT AC21 CESS TO MEDICATIONS. 

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

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

24 Human Services, acting through the Commissioner of 

25 Food and Drugs and the Director of the Centers for DisVerDate Sep 11 2014 06:46 Jan 28, 2015 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H471.IH H471

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1 ease Control and Prevention, and in consultation with the 

2 Administrator of the Drug Enforcement Administration 

3 and the Director of National Drug Control Policy, shall 

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

5 House of Representatives, the Committee on Energy and 

6 Commerce of the House of Representatives, the Com7 mittee on the Judiciary of the Senate, and the Committee 

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

9 identifying— 

10 (1) obstacles to legitimate patient access to con11 trolled substances; 

12 (2) issues with diversion of controlled sub13 stances; and 

14 (3) how collaboration between Federal, State, 

15 local, and tribal law enforcement agencies and the 

16 pharmaceutical industry can benefit patients and 

17 prevent diversion and abuse of controlled substances. 

18 (b) CONSULTATION.—The report under subsection 

19 (a) shall incorporate feedback and recommendations from 

20 the following: 

21 (1) Patient groups. 

22 (2) Pharmacies. 

23 (3) Drug manufacturers. 

24 (4) Common or contract carriers and ware25 housemen. 


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

2 providers. 

3 (6) State attorneys general. 

4 (7) Federal, State, local, and tribal law enforce5 ment agencies. 

6 (8) Health insurance providers and entities that 

7 provide pharmacy benefit management services on 

8 behalf of a health insurance provider. 

9 (9) Wholesale drug distributors. 

Æ 


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