Ensuring Patient Access and Effective Drug Enforcement Act of 2014

Bill: 113-hr-4709
Sponsor: Rep. Marino, Tom [R-PA-10]
Introduced: 2014-05-21 in the House
Policy area: Crime and Law Enforcement
Subjects: Administrative remedies
Congressional oversight
Department of Justice
Drug trafficking and controlled substances
Government information and archives
Government studies and investigations
Health care coverage and access
Licensing and registrations
Prescription drugs
Retail and wholesale trades

Summary:
action_date: 2014-05-21
text: 
Ensuring Patient Access and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to provide that: (1) a determination by the Attorney General that a registration to manufacture, distribute, or dispense a controlled substance is "consistent with the public health and safety" means that it has a substantial relationship to such Act's purpose of preventing diversion and abuse of controlled substances; and (2) a finding of "imminent danger" by the Attorney General justifying immediate suspension of such a registration means that there is a significant and present risk of death or serious bodily harm that is more likely than not to occur in the absence of such a suspension.
 
Requires the Attorney General, before revoking or suspending a registration under such Act, to: (1) provide the registrant notice of the grounds for doing so, and where such grounds consist of a legal violation, a specific citation to such law; (2) give the registrant an opportunity to submit a corrective action plan within a reasonable time period; and (3) determine whether, in light of the plan, revocation or suspension proceedings should be discontinued or deferred or additional changes need to be made in such plan.
 
Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to submit a report: (1) assessing how patient access to medications could be adversely impacted by federal and state law enforcement activities, and (2) identifying how collaboration between agencies and stakeholders can benefit patients and prevent diversion and abuse of controlled substances. 

action_date: 2014-07-29
text: 
Ensuring Patient Access and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to define: (1) "factors as may be relevant to and consistent with the public health and safety," for purposes of the Attorney General's determination of whether registering an applicant to manufacture or distribute a controlled substance in schedule I or II is in the public interest, as factors that are relevant to and consistent with the findings of such Act; and (2) "imminent danger to the public health or safety," for purposes of the suspension of such a registration, to mean that in the absence of an immediate suspension order, controlled substances will continue to be intentionally diverted outside of legitimate distribution channels or distributed or dispensed outside the usual course of professional practices or in a manner that poses a present or foreseeable risk of serious adverse health consequences or death.
 
Requires an order to show cause as to why such a registration should not be denied, revoked, or suspended to: (1) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated; (2) direct the applicant or registrant to appear before the Attorney General at a specific place and time within 30 days after receipt of the order; and (3) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before such appearance. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modifications to such plan. Makes such requirements inapplicable to the issuance of an immediate suspension order.
 
Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to submit a report identifying: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.


Legislative actions:
action_date: 2014-07-30
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2014-07-29
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2014-07-29
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7004-7005)
action_date: 2014-07-29
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H7004-7005)
action_date: 2014-07-29
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 4709.
action_date: 2014-07-29
text: Considered under suspension of the rules. (consideration: CR H7004-7007)
action_date: 2014-07-29
text: Mr. Pitts moved to suspend the rules and pass the bill, as amended.
action_date: 2014-07-29
text: Reported by the Committee on Energy and Commerce. H. Rept. 113-605, Part I.
action_date: 2014-07-29
text: Reported by the Committee on Energy and Commerce. H. Rept. 113-605, Part I.
action_date: 2014-07-21
text: Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
action_date: 2014-06-10
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2014-06-10
text: Committee Consideration and Mark-up Session Held.
action_date: 2014-06-09
text: Committee Consideration and Mark-up Session Held.
action_date: 2014-05-23
text: Referred to the Subcommittee on Health.
action_date: 2014-05-21
text: 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.
action_date: 2014-05-21
text: 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.
action_date: 2014-05-21
text: Introduced in House
action_date: 2014-05-21
text: Introduced in House