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Regulatory Update, May 2017

Monday, May 1, 2017

FDA Publishes Final Guidance Documents

Interested parties may submit electronic or written comments on these final guidance documents at any time, as instructed for the first document and with the indicated Docket Number included in the comments.

Assessment of Abuse Potential for Drugs

In the January 18, 2017, Federal Register, the FDA announced availability of a final guidance titled, “Assessment of Abuse Potential of Drugs.” This guidance is intended to assist sponsors of investigational new drugs (IND) and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. Specifically, this guidance provides recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs. Drug products with abuse potential generally contain drug substances that are active within the CNS and produce psychoactive effects such as euphoria and hallucinations. If a drug substance is CNS-active, the new drug product containing that drug substance likely will need to undergo a thorough assessment of its abuse potential and may be subject to control under the Controlled Substances Act (CSA).

Under the Federal Food, Drug, and Cosmetic Act, an abuse potential assessment is part of the general evaluation of the safety and efficacy of a new drug to be used under medical supervision. If a new drug has abuse potential, the HHS Secretary is required to make a recommendation for scheduling to the Drug Enforcement Administration (DEA). The FDA’s Controlled Substance staff, in consultation with the National Institute on Drug Abuse (NIDA) conducts the medical and scientific analysis on behalf of the HHS, as described in a March 8, 1985, Memorandum of Understanding.

When an applicant submits a New Drug Application (NDA) for a drug with abuse potential to the FDA for review, the applicant is required to propose a CSA schedule for the new drug. The FDA considers the applicant’s proposal during its evaluation of the drug’s abuse potential. The FDA prepares a scientific analysis with a recommendation for scheduling the drug under the CSA, based on consideration of all relevant and available data. This recommendation is forwarded by the HHS to the DEA for their consideration in the decision on final scheduling of the drug.

Under new legislation enacted in 2015, the Improving Regulatory Transparency for New Medical Therapies Act, upon receipt of both (1) notification from the FDA that a marketing application has been approved by the FDA and (2) the scheduling recommendation of the HHS with respect to the subject drug in the marketing application, within 90 days, the DEA schedules the drug by rulemaking, establishing the effective date of approval for the drug product. Control under Schedules II, III, IV or V results in schedule-specific regulatory requirements relating to the drug’s labeling, prescribing, dispensing, advertising, manufacturing, distribution, import/export, promotion, marketing and legitimate use in medical treatment. Scheduling of a substance in the CSA is for the purpose of reducing abuse and diversion.

This guidance provides important recommendations to sponsors, applicants and potential applicants in the approaches to collecting data that should comprise the abuse potential assessment submitted in the marketing application to the FDA if one is required.

This guidance makes final the draft guidance of the same name issued on January 27, 2010. Based on the comments received on the 2010 draft, this guidance provides the FDA’s current thinking with respect to the scientific methods recommended to assess abuse potential. The guidance also adds more detailed discussion about key questions and decision points to consider during drug development that will likely determine the appropriate studies for sponsors and applicants to conduct to address the abuse potential of their new drug, inform appropriate labeling of the product upon its approval, and allow a thorough scientific and medical evaluation to support scheduling decisions in accordance with the CSA. In addition, this guidance takes into consideration other guidance issued and legislation enacted since 2010.

Interested parties may submit electronic or written comments on final guidance at any time. The FDA may consider those comments for future revisions. Submit electronic comments at http://www.regulations.gov/. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Identify comments with Docket No. FDA-2010-D-0026. FDA also has instructions on how to submit confidential information. If those instructions are not followed, any submitted confidential information will be made public.

Benefit-Risk Determinations for Medical Device IDEs

In the January 13, 2017, Federal Register, the FDA announced availability of a final guidance titled, “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.” The purpose of this guidance is to provide greater clarity for FDA staff and Investigational Device Exemptions (IDE) application sponsors and sponsor-investigators regarding the principal factors that the FDA considers when assessing the benefits and risks of IDE applications for human clinical study. A primary goal of this guidance is to clarify the factors that the FDA considers when assessing risks and anticipated benefits for IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures that can ensure appropriate patient and participant protections in investigational research settings. At earlier stages of device development, the FDA considers appropriate mitigation measures for anticipated possible risks and unanticipated risks, whereas in later stages, risk mitigation focuses increasingly on the most probable risks. Another important goal of this guidance is to characterize benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent there are indirect benefits to subjects or reflect the importance of knowledge to be gained).

As with the benefit-risk framework for evaluating marketing applications, the FDA assessment of benefits and risks for an IDE application takes into account the contextual setting in which the study is being proposed, including, but not limited to, the characterization of the disease or condition being treated or diagnosed, the availability of alternative treatments or diagnostics and the risks associated with them. When available, information characterizing subject tolerance for risk and perspective on benefit may provide useful context during this assessment. The FDA considered all of the public comments received prior on the June 18, 2015 draft version of the guidance.

Interested parties may submit comments as described above. Identify comments with Docket No. FDA-2015-D-1777.  

The Regulatory Update is excerpted from Research Practitioner, Volume 18, Number 02, March-April 2017.

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