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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
APQ and the proposed AAN on or before November 17, 2021.

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III. Comments Received Within the public comment period, DEA received 610 comments from DEA
registrants, chronic pain patients, pain advocacy associations, professional associations, doctors, nurses, State Attorneys General, and others. The comments included requests for clarification about the data DEA used to determine diversion for the purposes of the APQ for certain schedule II opioids;
concerns about potential drug shortages due to further quota reductions;
concerns that medical professionals might be impeded from exercising their medical expertise regarding opioid prescriptions; concerns about the quota process; requests for a public hearing;
and comments not pertaining to DEA
regulated activities.
DEAs Regulatory Authority Issue: DEA received comments that raised the question of whether DEA has the authority to regulate activities related to controlled substances, including the manufacture of Food and Drug Administration FDA-approved pharmaceutical products containing controlled substances.
DEA Response: The CSA, which was initially enacted in 1970 and has been amended several times, requires DEA to establish production quotas for certain controlled substances. 21 U.S.C. 826a.
In the CSA, Congress granted DEA as delegated by the Attorney General under 21 U.S.C. 871a the authority to promulgate rules and regulations relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals 21 U.S.C. 821, and to the registration and control of importers and exporters of controlled substances 21 U.S.C. 958f, as well as those necessary and appropriate for the efficient execution of the authorities granted by the CSA 21 U.S.C. 871b, among other provisions. In its findings, Congress acknowledged that many controlled substances have a useful and legitimate medical purpose. 21
U.S.C. 8011.
Congress explicitly directed DEA to establish production quotas for controlled substances in schedule I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine. 21 U.S.C.
826a. In recognition of FDAs related but distinct role in regulating pharmaceutical products, DEAs regulations require DEA to consider relevant information from FDA before DEA establishes the APQs. As DEA has acknowledged in previous Federal
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Register publications relating to quotas, the responsibility to provide estimates of legitimate domestic medical needs resides with FDA. DEA considers this important information in proposing and revising the APQs.
Medication Shortages Issue: DEA received many comments expressing general concerns that the proposed decreases to the production quotas of certain controlled substances may result in shortages of drug products containing those controlled substances.
DEA Response: DEA is committed to ensuring an adequate and uninterrupted supply of controlled substances in order to meet the estimated legitimate medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. DEA sets APQs in a manner to provide for all legitimate medical purposes.
Additionally, DEA and FDA are required to, and routinely do, coordinate efforts to prevent or alleviate drug shortages pursuant to 21 U.S.C.
826h. Such efforts may include adjusting the APQ, adjusting individual domestic manufacturers quotas, FDA
approval of additional market competitors, and coordination between the agencies to allow importation of foreign-manufactured drug products that meet FDA approval. For example, in 2020, DEA adjusted its quota to increase the aggregate production quota for drug products containing fentanyl, hydromorphone, morphine, and codeine, and the assessments of annual needs for drug products containing pseudoephedrine and ephedrine. The increased production needs for those substances, which are used to treat patients in intensive care units and those on ventilators, was a result of the COVID19 public health emergency.
These actions were taken based on DEAs consultations with federal partners at the Department of Health and Human Services HHS, drug manufacturers, drug distributors, and hospital associations. Similarly, in 2018, a domestic shortage of injectable hydromorphone was alleviated through FDA and DEA collaboration to identify other dosage-form manufacturers with injectable hydromorphone products in the market, and to determine whether those other dosage-form manufacturers had the capability to increase their production levels to meet legitimate patient need in a timely manner. When the agencies determined that the domestic manufacturers could not increase production adequately to meet legitimate patient need, DEA and FDA

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coordinated and used their respective regulatory authorities to allow for the limited importation of injectable hydromorphone into the United States.
Prescribing Hesitancy Issue: Many commenters, most of whom self-identified as chronic pain patients, expressed general concerns that the CDC Guidelines for Prescribing Opioids for Chronic Pain, issued in 2016, are preventing doctors from prescribing pain medication in dosages that adequately control chronic pain, forcing them to taper opioid medication dosages inappropriately, and causing them to refuse to prescribe opioid prescriptions to chronic pain patients.
These comments also raised concerns that some health insurers have mandated that opioid medication dosages be tapered for continued insurance coverage or have denied coverage for prescriptions from out-ofnetwork providers. Commenters noted that workers compensation insurers have denied opioid medication coverage for pain patients. One commenter raised concerns that chronic pain patients are not allowed to self-pay for opioid medications.
DEA Response: Provided that the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice, neither the CSA
nor DEA regulations impose a specific minimum or maximum limit on the amount of medication that may be prescribed on a single prescription, or limit the duration of treatment intended with a prescribed controlled substance.
DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards, as outlined in DEAs policy statement published in the Federal Register on September 6, 2006, titled Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.
Use of Studies/Guidelines To Determine Medical Need Issue: Ten State Attorneys General 1
referred to collectively as State Attorneys General suggested that DEA
consider research studies and best practices developed by individual statelevel partnerships with local medical communities and other individual state regulators to determine the extent of 1 The comment received from the Office of the Attorney General, State of West Virginia, was also signed by the State Attorneys General of Kentucky, Arkansas, Alaska, Idaho, Louisiana, Mississippi, Nebraska, Utah and South Dakota.

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