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Nonprescription Drugs Advisory Committee and Pulmonary-Allergy Drugs Advisory Committee

Request for Comments:
Interested persons and organizations may submit electronic or written comments on the Agenda topic until January 6, 2006. Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select ‘‘2005N–0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over-the-Counter (OTC) Epinephrine Metered Dose Inhalers’’ and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Agenda:
The committee will discuss the continued need for the designation of OTC epinephrine-metered dose inhalers for the treatment of asthma as an essential use of ozone-depleting substances (ODSs) under § 2.125 (21 CFR 2.125). ODSs are substances that deplete the stratospheric ozone, which include chlorofluorocarbons (CFCs). Once released, CFCs rise to the stratosphere. In the stratosphere, CFCs are gradually broken down by strong ultraviolet light, and they release chlorine atoms that then deplete stratospheric ozone. Depletion of stratospheric ozone by CFCs and other ODSs leads to higher ultraviolet B radiation levels, which in turn increase skin cancers and cataracts, as well as cause other significant environmental damage. FDA is soliciting comments and data to support or refute an essential-use designation for OTC epinephrine metered-dose inhaler (MDI) drug products. These products include the only OTC drug available in an MDI dosage form for the treatment of asthma. The OTC epinephrine MDIs use CFCs as propellants. The OTC indication is ‘‘for temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma.’’ In some instances, use of this product early during an asthma attack could avert a serious or life-threatening worsening of the attack. There are currently a limited number of marketed OTC drug products containing epinephrine in a MDI dosage form.

According to § 2.125(f)(1), the following are criteria for continued ODS essential-use designation:

(1) Substantial technical barriers exist to formulating the product without ODSs;
(2) The product will provide an otherwise unavailable important public health benefit; and
(3) Use of the product does not release cumulative significant amounts of ODSs into the atmosphere or the release is warranted in view of the high probability of an unavailable important public health benefit.

Under section 610 of the Clean Air Act (42 U.S.C. 7671(i)), MDIs that are not the subject of an essential-use designation cannot be legally distributed in interstate commerce.

We particularly encourage comments on the second criterion in § 2.125(f)(i) regarding the public health benefit derived from the availability of these products in the OTC setting. Information that may aid in the Committee’s discussion of essential use includes:

• Who currently uses OTC epinephrine MDIs?
• How many of these MDIs are used annually?
• What are the alternatives if these products are no longer available?
• From literature sources, what is the value of use of the product to the users, and why do they use it?
• What established treatment guidelines recommend the use of OTC epinephrine?
• How many people with asthma do not have ready access to prescription medication through healthcare professionals?

Background material and meeting information will become available no later than one business day before the meeting.

Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. Written comments should be submitted by close of business January 6, 2006, to the Division of Dockets Management (see Request for Comments section above). Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by close of business January 6, 2006, and submit a brief statement of the general nature of the information they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Darrell Lyons (see Contact Person) at least 7 days in advance of the meeting.

Contact Person:
Darrell Lyons, Center for Drug Evaluation and Research (HFD 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, (301–827–7001, FAX: 301–827–6776, e-mail: lyonsd@cder.fda.gov.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), codes 3014512541 or 3014512545.