2010-13769. Investigational New Drug Applications; Co-development of Investigational Drugs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; establishment of docket; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is establishing a public docket to obtain input on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to develop guidance for industry and other affected parties on the co-development of two or more novel drugs intended to be used in combination (but not as not fixed-dose combinations) and is seeking public input to identify the affected parties' information needs concerning such co-development. Accordingly, FDA is seeking comment on general methodologic and regulatory issues that arise in various scenarios when co-developing two or more investigational drugs intended to be used in combination. FDA is also seeking comment on methodologic and regulatory issues when co-developing two or more investigational drugs intended to be used in combination for specific therapeutic areas, including oncology, anti-infectives, seizure disorders, cardiovascular diseases, and any other therapeutic category in which such co-development is likely to occur.

DATES:

Submit either electronic or written comments by September 7, 2010.

ADDRESSES:

Submit written comments 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.

FOR FURTHER INFORMATION CONTACT:

Colleen L. Locicero, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4200, Silver Spring, MD 20993-0002, 301-796-2270.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is aware of growing interest in co-developing two or more distinct, novel investigational drugs intended to be used in combination to treat a disease or condition (but not as fixed-dose combinations under 21 CFR 300.50). At a September 2009 conference co-hosted by the “Friends of Cancer Research” in partnership with the Engelberg Center for Health Care Reform at the Brookings Institution, and supported by the American Society for Clinical Oncology (ASCO), the American Association for Cancer Research (AACR) Susan G. Komen for the Cure, and the Lance Armstrong Foundation (Brookings Conference), which was attended by FDA scientists, there was considerable interest in approaches to developing new oncology therapies intended to be used in combination. In addition, on April 30, 2010, FDA held a public hearing in accordance with part 15 (21 CFR part 15) devoted, in part, to obtaining information about study designs and appropriate populations for developing two or more novel, direct-acting antivirals intended to be used in combination for the treatment of chronic hepatitis C. FDA is also aware of efforts to try to develop two or more investigational drugs intended to be used in combination to treat tuberculosis. FDA is further aware of general uncertainty about the evidentiary requirements and regulatory criteria applicable to such co-development efforts. Accordingly, FDA is planning to develop generally applicable guidance (not restricted to oncology or any other specific therapeutic category) to address methodologic and regulatory issues related to the co-development of two or more investigational drugs intended to be used in combination.

II. Issues on Which FDA is Seeking Comment

All material submitted to this docket will be publicly available. To facilitate development of guidance that meaningfully addresses the concerns of those who may co-develop drugs intended to be used in combination, FDA is seeking input on the following issues, and any other issues relevant to developing FDA guidance:

1. General methodologic and regulatory issues that arise in the co-development of two or more drugs intended to be used in combination where the drugs are directed at providing a therapeutic effect on the same symptom or manifestation of the disease or condition of interest, including relevance and utility of clinical or animal findings for either drug alone;

2. General methodologic and regulatory issues that arise in the co-development of two or more drugs intended to be used in combination where the drugs are directed at providing a therapeutic effect for the same disease or condition, but act on different symptoms or manifestations of that disease or condition, including relevance and utility of clinical or animal findings for either drug alone;

3. General methodologic and regulatory issues that arise in the co-development of two or more drugs intended to be used in combination where one or more of the drugs is intended to enhance the effectiveness of the other, but one or more of the drugs does not or may not have an independent therapeutic effect, including relevance and utility of clinical or animal findings for either drug alone; and

4. Methodologic and regulatory issues that arise in the co-development of two or more drugs intended to be used in combination for specific therapeutic categories, including oncology, anti-infectives, seizure disorders, cardiovascular diseases, and any other therapeutic category in which such co-development is likely to occur.

III. Submission of Comments

Interested parties may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necesary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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.

Dated: June 2, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.