Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014

Summary

Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule under the exception for good cause, placing it into the schedule recommended, effective immediately. Allows a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the registration application that the substance will be used only in connection with clinical trials of a drug. Requires the Attorney General to: (1) make a final decision on such application within 180 days, or (2) provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date on which such decision will be made. Defines: (1) "factors as may be relevant to and consistent with the public health and safety," and (2) "imminent danger to the public health or safety." Requires an order to show cause as to why a registration should not be denied, revoked, or suspended to notify the registrant of the opportunity to submit a corrective action plan on or before the date of appearance before the Attorney General. 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 modification or clarification of such plan. Makes these requirements inapplicable to the issuance of an immediate suspension order. Directs the Secretary, acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to identify: (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.

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Timeline

1. 18 September 2014

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 18 September 2014

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 18 September 2014 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 18 September 2014

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 18 September 2014

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 18 September 2014

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Hatch, Orrin G. [R-UT] · R · Sponsor
• Sen. Whitehouse, Sheldon [D-RI] · D · Sponsor
• Sen. Paul, Rand [R-KY] · R · Cosponsor
• · sshr00 · Standing

Related records

• related to → Improving Regulatory Transparency for New Medical Therapies Act
• related to → Ensuring Patient Access and Effective Drug Enforcement Act of 2014