viernes, 8 de diciembre de 2017

The Opioid Abuse Deterrence Act and DOJ Initiatives: Just What the Doctor Ordered?

The Opioid Abuse Deterrence Act and DOJ Initiatives: Just What the Doctor Ordered?

Link to FDA Law BlogLink to FDA Law BlogLink to FDA Law Blog

Posted: 07 Dec 2017 08:48 PM PST
By John A. Gilbert & Larry K. Houck —
“For Americans under the age of 50, drug overdoses are now the leading cause of death.” DOJ, Attorney General Jeff Sessions Delivers Remarks Announcing New Tools to Combat the Opioid Crisis (Nov. 29, 2017) (here).  “With evidence suggesting that nearly 80 percent of individuals addicted to heroin started out on opioid pain relievers, the link is clear that opioid prescriptions are driving this epidemic.”  Rep. Mark Meadows, Opioid Abuse Deterrence, Research and Recovery Act (here).  These statements by government officials, one representing the Trump Administration, the other from Congress, provide a sobering picture of the nationwide opioid abuse epidemic and form the basis for two new actions designed to stem the opioid crisis.  On November 29, 2017, Congressman Mark Meadows (R-NC) introduced H.R. 4482, the Opioid Abuse Deterrence, Research, and Recovery Act of 2017.  On the same day, Attorney General Jeff Sessions announced several Department of Justice (“DOJ”) and Drug Enforcement Administration (“DEA”) efforts also aimed at addressing the crisis.

Opioid Abuse Deterrence, Research, and Recovery Act of 2017

The Opioid Abuse Deterrence, Research and Recovery Act (“the Act”) would amend the Federal Controlled Substances Act (“CSA”) to require DEA-registered and state-licensed practitioners authorized to prescribe schedule II or III controlled substances to submit a “certification” to DEA that they will not prescribe a schedule II or III opioid “for the initial treatment of acute pain” unless the prescribed quantity is for less than seven days or falls within a State-established prescription limit. “Acute pain” is defined as “pain with abrupt onset and caused by an injury or other process that is diagnostically determined to have minimal risk of escalating in intensity.”  “Acute pain” under the Act does not include chronic pain, pain treated as part of cancer care, hospice, end-of-life care, or palliative care.

Under the Act, the certification would not prevent practitioners from prescribing opioids approved by FDA for opioid use disorder treatment; for immediate, post-operative pain relief; or for longer than seven days if prescribing is consistent “with a clear medical standard of care,” provided that the practitioner documents the prescription in the patient’s medical record and consults the State electronic health record system or prescription drug monitoring program.

The legislation would also require the FDA Commissioner to continue working with stakeholders and encouraging the development of abuse-deterrent opioids. In addition, to understand what led to the opioid crisis, the Act requires the Comptroller General to submit a report to Congress within two years on the health care policy changes that may have contributed to the increase in opioid overdoses and deaths.  The report must include:

  1. A review of the federal health care-related legislative, administrative, and judicial decisions that affected access to pharmaceutical pain management strategies;
  2. An analysis of the financial and non-financial costs and benefits of reversing or revising such decisions;
  3. An analysis of the differences between State prescription drug monitoring programs;
  4.  An analysis of the impacts of State and Federal prescribing limitations on patient medical outcomes; and
  5. An analysis of the costs of using abuse-deterrent opioids compared to non-abuse-deterrent opioids.
Finally, the Act would require the FDA Commissioner to conduct a study on the feasibility of replacing the prescribing limits in the bill “with evidence-based clinical guidelines,” including a limitation “on the first opioid prescription for patients for an acute pain diagnosis” and “the incorporation into routine medical visits of evidence-based screening tools [to monitor] the misuse of opioids and other controlled substances.”

HPM Comments

We have long believed that effectively addressing the opioid epidemic requires focus on the physicians, doctors, dentists, and other practitioners who are the gatekeepers of public access to controlled substances. It is clear that overprescribing or inappropriate prescribing of controlled substances has been a significant cause in creating and sustaining the opioid abuse crisis.

The Act was clearly drafted with the Centers for Disease Control and Prevention’s (“CDC’s”) Guidelines for Prescribing Opioids for Chronic Pain in mind. While the CDC guidelines voluntarily limit opioid prescribing for chronic pain, the Act limits only the first or initial prescription of schedule II or III opioids to treat acute pain to seven days unless the practitioner fulfills requirements to prescribe for a longer period.  In fact, the Act does not reference prescribing for chronic pain.  Both the Act and the CDC guidelines focus on a theme that we believe is a significant contributor to the opioid abuse problem, that is, overprescribing or inappropriate prescribing of controlled substances.  However, the mechanics of having a prescriber provide a “certification” to DEA is problematic.  There are no details on how prescribers would “certify” (e.g., during the application or renewal process).  More importantly, the Act does not address the regulatory effect of certifying or, even more significantly, failure to comply with the certification.  It also fails to address whether practitioners will self-certify or obtain certification for submission from an official or unofficial organization.  It is worth noting that the CSA and DEA regulations related to sales of pseudoephedrine, provide for a certification by retail sellers that they will not sell in amounts greater than allowed under the CSA.  21 U.S.C. § 830(e)(1)(A)(vii); 21 C.F.R. §§ 1314.35-.42, 1314.101-.103.  Regardless, the Act’s requirements will make practitioners more carefully consider issuing a first opioid prescription for longer than seven days.  The inescapable downside is that some overly cautious practitioners may decline to issue necessary prescriptions to legitimate patients for longer than a week if they do not want to adhere to the requirements to do so or from fear that they will appear on DEA’s radar.

We believe that mandatory training and education for practitioners is more critical and an alternative would be to require that all practitioners who intend to be registered with DEA to prescribe Schedule II controlled substances should certify that they have received such training.

DOJ and DEA Initiatives

Attorney General Sessions announced several initiatives including a restructuring of DEA Field Offices to focus on the opioid abuse problem. The Attorney General announced that DOJ was awarding $12 million to law enforcement agencies in states hit hard by illegal prescription opioid, heroin, and methamphetamine activity.  DOJ awarded $7 million through its Anti-Heroin Task Force Program to investigate heroin and illegal opioid distribution in states with high per capita levels of treatment admissions for heroin and other opioids, and $5 million through the Anti-Methamphetamine Program to states that have “demonstrated numerous seizures of precursor chemicals, finished methamphetamine, laboratories, and laboratory dump seizures.” DOJ, Attorney General Sessions and Acting DEA Administrator Patterson Announce New Tools to Address Opioid Crisis (Nov. 29, 2017) (here).

Attorney General Sessions also announced the formation of a new DEA Louisville Field Division. This new office will strengthen DEA investigation and enforcement efforts under a single Special Agent in Charge in Kentucky, Tennessee, and West Virginia.  The geographic area served by the new Louisville Field Division was previously distributed among the Detroit, Atlanta, and Washington, D.C., Field Divisions.  The Attorney General anticipates that consolidating Kentucky, Tennessee, and West Virginia within a single jurisdiction “will produce more effective investigations on heroin, fentanyl, and prescription opioid trafficking, all of which have a significant impact on the region.” Id.

Lastly, the Attorney General directed every U.S. Attorney to designate an Opioid Coordinator for their district by December 15th. The Attorney General’s memo to all U.S. Attorneys instructed that Opioid Coordinators will be responsible for:

  • Facilitating intake of cases involving prescription opioids, heroin, and fentanyl;
  • Convening a task force of federal, state, local, and tribal law agencies to identify opioid cases for federal prosecution, facilitate interdiction efforts, and tailor their district’s response to the needs of their communities;
  • Advising and training Assistant United States Attorneys on prosecuting opioid offenses;
  • Maintaining statistics on opioid prosecutions; and
  • Developing and evaluating the strategy to combat the opioid epidemic.
HPM Comments  

The creation of a new DEA Field Office focuses on several states particularly hard hit by the opiate abuse problem. Thus, it makes sense that DEA would consolidate resources to narrow the geographic scope to address these issues.  DEA drug investigations are better coordinated and more efficient when conducted within a single Field Division rather than multiple jurisdictions.  It also seems to us that the creation of an Opioid Coordinator should result in a more focused approach by U.S. Attorney offices to the opioid problem.  We note that in August 2017 the Attorney General had announced the formation of the Opioid Fraud and Abuse Detection Unit, which is a pilot program funding 12 prosecutors nationwide to focus on investigating and prosecuting health care fraud related to prescription opioids. Thus, DOJ/DEA is devoting significant resources to the fight against opioid abuse, which will likely result in more criminal, civil and administrative actions.

No hay comentarios: