Ensuring Patient Access and Effective Drug Enforcement Act of 2015
Introduced on 1-22-15 by Tom Marino and referred to the Committees of Energy and Commerce and Judiciary. Also in the Senate Judiciary Committee. Cosponsors were Peter Welch [D-VT-At Large], Marsha Blackburn [R-TN-7], Judy Chu [D-CA-27], Doug Collins [R-GA-9], Gus Bilirakis [R-FL-12], and Ryan Costello [R-PA-6]. A related Bill is S.483.
On 4-19-16, this Bill became Public Law No: 114-145.
Amendments to the Controlled Substances Act (21 U.S.C. 823)
SEC. 2. Registration process under Controlled Substances Act.
Section 303: adding at the end the following: “the phrase ‘factors as may be relevant to and consistent with the public health and safety’ means factors that are relevant to and consistent with the findings contained in section 101.”
(d) the phrase ‘imminent danger to the public health or safety’ means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this title or title III, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.
Opportunity To submit corrective action plan prior to revocation or suspension.—Subsection (c)
“(2) An order to show cause under paragraph (1) shall—
“(A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant;
“(B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and
“(C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance.
“(3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan.
“(4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5, United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this title or any other law of the United States.
“(5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d).”
SEC. 3. Report to Congress.
Within 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall submit a report to the Committee on the Judiciary of the House of Representatives, the Committee on Energy and Commerce of the House of Representatives, the Committee on the Judiciary of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate identifying—
(1) obstacles to legitimate patient access;
(2) issues with diversion;
(3) how collaboration between Federal, State, and local law enforcement and the pharmaceutical industry can benefit patients and prevent diversion and abuse;
(4) the availability of medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing, and any gaps that should be addressed;
(5) beneficial enhancements to State prescription drug monitoring programs,
(6) steps to improve reporting requirements regarding prescription opioids, such as the volume and formulation, the dispensing and trends.
The report shall incorporate feedback and recommendations from patient groups, pharmacies, drug manufacturers, health care providers, state attorneys general, law enforcement agencies, insurance providers, medical societies and boards, veterinarians, public health authorities, and research organizations.