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Public Law No: 114-145
“Ensuring Patient Access and Effective Drug Enforcement Act of 2016”

 

Formerly S. 483, introduced on 2/12/15 by Orrin Hatch [R-UT], became law on 4-19-16. Cosponsored by Sheldon Whitehouse [D-RI], Marco Rubio [R-FL], David Vitter [R-LA], and Bill Cassidy [R-LA].  The identical House Bill was H.R. 471, introduced 1-22-15 by Tom Marino [R-PA-10] and cosponsored by Peter Welch [D-VT-At Large], Marsha Blackburn [R-TN-7], Judy Chu [D-CA-27], Doug Collins [R-GA-9] and Gus Bilirakis [R-FL-12] and which passed the House of Representatives April 21, 2015.

This law doesn’t ensure patient access at all. In fact, from the fact that multiple good doctors such as Doc. Myers and Dr. Gozy have recently been charged criminally for prescribing, my prediction is that this law will mark the end of the prescribing of opiates for pain in the United States.

The choice here was the Justice Department and how they interpret this law. But since they have, over the last 15 years, interpreted the CSA so broadly as to charge innocent doctors, such as myself, with crimes and used the “inconsistent with public health and safety” clause without justification simply just to deny certificates to anyone they choose, this law gives them even more freedom to attack good doctors. What the legislature should have done is reign in the Justice Department. Instead, they removed the bridle.

You're fired300For that reason, I recommend the firing of any legislator who voted Yea on this bill or on House Bill 471. Can that be done with the November election?  Instead of whining and moaning, all of you in chronic pain support groups, Facebook groups, and any other organization need to get busy and spread the word about any legislator whose position is being contested. You can find that list on this website under “Call to Action”.  Then get the word through letters to the remaining legislators that if this law isn’t amended to exempt physicians from any criminal charge pertaining to prescriptions written for physical patients who are seen in their offices, their jobs will end in 2 years.

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.”

Section 304

(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.

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