I 

113TH CONGRESS 

2D SESSION H. R. 4709 

To improve enforcement efforts related to prescription drug diversion and 

abuse, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 21, 2014 

Mr. MARINO (for himself, Mrs. BLACKBURN, Mr. WELCH, and Ms. CHU) 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 2014’’. 

6 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 

7 SUBSTANCES ACT. 

8 (a) DEFINITIONS.— 


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1 (1) CONSISTENT WITH THE PUBLIC HEALTH

2 AND SAFETY.—Section 303 of the Controlled Sub3 stances Act (21 U.S.C. 823) is amended by adding 

4 at the end the following: 

5 ‘‘(j) In this section, the phrase ‘consistent with the 

6 public health and safety’ means having a substantial rela7 tionship to this Act’s purpose of preventing diversion and 

8 abuse of controlled substances.’’. 

9 (2) IMMINENT DANGER.—Section 304(d) of the 

10 Controlled Substances Act (21 U.S.C. 824(d)) is 

11 amended— 

12 (A) by striking ‘‘(d) The Attorney Gen13 eral’’ and inserting ‘‘(d)(1) The Attorney Gen14 eral’’; and 

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

16 ‘‘(2) In this subsection, the term ‘imminent danger’ 

17 means a significant and present risk of death or serious 

18 bodily harm that is more likely than not to occur in the 

19 absence of an immediate suspension order.’’. 

20 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

21 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Section 

22 304(c) of the Controlled Substances Act (21 U.S.C. 

23 824(c)) is amended— 

24 (1) by striking ‘‘(c) Before’’ and inserting 

25 ‘‘(c)(1) Before’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(2) Before revoking or suspending a registration 

3 pursuant to section 303, the Attorney General shall— 

4 ‘‘(A) provide— 

5 ‘‘(i) notice to the registrant of the grounds 

6 for revocation or suspension; and 

7 ‘‘(ii) in the case of any such grounds con8 sisting of a violation of law, a specific citation 

9 to such law; 

10 ‘‘(B) give the registrant an opportunity to sub11 mit a corrective action plan within a reasonable pe12 riod of time to demonstrate how the registrant plans 

13 to correct the grounds for revocation or suspension; 

14 and 

15 ‘‘(C) determine whether— 

16 ‘‘(i) in light of the plan, revocation or sus17 pension proceedings should be discontinued or 

18 deferred; or 

19 ‘‘(ii) additional changes need to be made in 

20 the corrective action plan.’’. 

21 SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN22 FORCEMENT ACTIVITIES ON PATIENT AC23 CESS TO MEDICATIONS. 

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

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


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1 Human Services, acting through the Commissioner of 

2 Food and Drugs and the Director of the Centers for Dis3 ease Control and Prevention, and in consultation with the 

4 Administrator of the Drug Enforcement Administration 

5 and the Director of National Drug Control Policy, shall 

6 submit a report to the Congress— 

7 (1) assessing how patient access to medications 

8 could be adversely impacted by Federal and State 

9 law enforcement activities; and 

10 (2) identifying how collaboration between agen11 cies and stakeholders can benefit patients and pre12 vent diversion and abuse of controlled substances. 

13 (b) CONSULTATION.—The report under subsection 

14 (a) shall incorporate feedback and recommendations from 

15 the following: 

16 (1) Patient groups. 

17 (2) Pharmacies. 

18 (3) Manufacturers of drugs. 

19 (4) Common or contract carriers and ware20 housemen. 

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

22 providers. 

23 (6) State attorneys general. 

24 (7) Law enforcement officials, including local 

25 law enforcement officials. 


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1 (8) Health benefit plans and entities that pro2 vide pharmacy benefit management services on be3 half of a health benefit plan. 

4 (9) Wholesale drug distributors. 

Æ 


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