Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Assessment of Abuse Potential of Drugs.” This draft guidance is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act. Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by March 29, 2010.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Corinne P. Moody, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5144, Silver Spring, MD 20993-0002, 301-796-5402.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Assessment of Abuse Potential of Drugs.” 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 drug to be used under medical supervision. If a drug has abuse potential, the Secretary of Health and Human Services (HHS) is required under the Controlled Substances Act of 1970 (CSA) to make a recommendation for scheduling to the Drug Enforcement Administration (DEA). The regulatory responsibilities for this process are described in Title 21 United States Code (U.S.C.) 811, with delegation of authority to FDA from HHS. The Controlled Substance Staff (CSS) of FDA performs the scientific evaluation of the abuse potential of a drug for HHS, in consultation with the National Institute on Drug Abuse (NIDA), as described in a Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518).

When a sponsor submits a marketing application for a drug with abuse potential to FDA for review, the sponsor is required to propose a CSA schedule and provide a basis for this proposal (21 CFR 314.50(d)(5)(vii)). The sponsor's proposal is considered by the agency during its evaluation of the drug's abuse potential. At the time a marketing application is submitted to FDA for review, the sponsor signs a statement agreeing not to market the product until the DEA makes a final scheduling decision.

FDA prepares a scientific analysis with a recommendation for scheduling, based on the submission of the sponsor that includes a scientific and medical evaluation of all relevant and available data, an assessment of the public health risk, and a proposal for scheduling. This recommendation is forwarded to DEA for consideration in the decision on final scheduling of the drug. Scheduling results in specific regulatory requirements relating to the drug's labeling, prescribing, advertising, manufacturing, promotion, marketing, and use in the practice of medicine. Not following these requirements can result in criminal penalties.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on assessing abuse potential of drugs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov .