Final Minutes- May 11, 2001 - Joint Meeting
Nonprescription Drugs Advisory Committee &
Pulmonary - Allergy Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
Holiday Inn, 2 Montgomery Avenue, Gaithersburg, MD
Petition 98P-0610/CP1 - submitted by Blue Cross of California requesting fexofenadine hydrochloride, loratadine and cetirizine hydrochloride to OTC status
The meeting was held at the Holiday Inn, Gaithersburg, MD. Prior to the meeting, the members and consultants reviewed background material from the FDA, from the petitioner – Blue Cross (Wellpoint), and from the sponsors. In order for the public to be informed, the background material was also available on the Dockets page for many weeks before the meeting. There were approximately 350 persons in attendance. The meeting started at 8 a.m. and ended at 4:00 p.m.
NDAC Members Present: Eric Brass, M.D., Ph.D., NDAC Chair and Chair of the meeting, Richard Neill, M.D., Edwin Gilliam, Ph.D., Julie Johnson, Pharm.D., Hari Sachs, M.D., Louis Cantilena, M.D., Ph.D., Edward Krenzelok, Francis Lam, Pharm.D., Donald Uden, Pharm.D., Henry Williams, M.D., George Blewitt, M.D.(non-voting industry rep)
NDAC Members Absent: none
NDAC Voting Consultants: Leslie Clapp, M.D., Ralph D’Agostino, Ph.D., Alastair Wood, M.D., Sonia Patten, Ph.D.
PADAC Members Present: Consumer Rep: Brenda H. Connor, William Vollmer, Ph.D., Andrea Apter, M.D., Jesse Joad, M.D., Mark Dykewicz, M.D., H William Kelly, PADAC Chair, Robert Fink, M.D., Jean Ford, M.D., Michael Niederman, M.D.
PADAC Members Absent: James K. Stroller, M.D., Nicholas Gross, M.D.
PADAC Members Recused: James Li, M.D., Ph.D.
PADAC Consultants: James Baraninuk, M.D. (non-voting),
Cardiology Consultant: Dan Roden, M.D., (voting)
FDA Participants: Sandra Kweder, M.D., Robert Temple, M.D., Ph.D., John Jenkins, M.D., Charles Ganley, M.D., Robert Meyer, M.D., Cazemiro Martin, Anne Trontell, M.D., M.P.H., Claudia Karwoski, Pharm.D., Joyce Weaver, Pharm.D.
FDA Present: Linda Hu, Debra Birenbaum, Walt Ellenberg, Robert Sherman, Michelle Jackson, Arlene Solbeck, Lee Ripper, Andrea Masciale, Gretchen Trout, David Hilfiker, Ray Anthracite, Parinda Jani, Lydia Gilbert-McClain, Susan Johnson, Laurie Lenkel, Marianne Mann, Charles Lee, Craig Ostroff, Mary Purucker, Chris Rosebraugh, Daiva Shetty, Andrea Leonard-Segal, James Gebert, Badrul Chowdhury, Eugene Sullivan, Igor Cerny, Marina Chang, Leigh Hayes, Michael Benson, Gerald Rachanow, Christine Yu, Don Collier, Sharan Jayne, Marcia Meyer, Maritin Himmel, Emmanuel Fadiran, Kathleen Bongiovanni, Joyce Weaver, Allen Brinker, Robert DeLap, Linda Katz, Peter Honig, Lauren Parcover, Bonita Moore, John Treacy, Min Chen, Jonca Bull, Babette Merritt
Open Public Hearing presentations
All speakers were asked to limit their comments to five minutes. All speakers were asked to disclose their possible sources of conflict of interest before beginning their presentation.
Session 1: 10:15-11am
Eric Schenkel, M.D., Director, Valley Allergy and Asthma Treatment Center, Easton, Pennsylvania
Ivor Emanuel, M.D., Clinical Assistant Professor, Department of Otolaryngology, University of California, San Francisco, representing Pharmacia Diagnostics
Daniel Hussar Ph.D., Remington Professor of Pharmacy, Philadelphia College of Pharmacy
Charles Cutler, M.D., Chief Medical Officer, American Association of Health Plans
Not present; statement submitted to dockets.
Health Consultants to Employers
Frank Brocato, President/CEO, Employers Health Coalition, Tampa Florida
Coalition representing consumer, provider and employer
Mark Cloutier, MPH, MPP, Policy Director, RXHealthValue
Michael Parker, M.D., American Academy of Otolaryngic Allergy (AAOA)
J.A. Quel, M.D., Executive Director, Hispanic American Allergy, Asthma, Immunology Association (HAAMA)
Session 2: 1-2pm (after the lunch break)
Bobby Lanier, M.D., American Academy of Asthma, Allergy and Immunology (AAAAI) and College of Allergy, Asthma and Immunology
Michael Kaliner, M.D., Vice President of the World Allergy Association
Nancy Sander, Allergy and Asthma Network Mothers of Asthmatics
Richard Carson, Asthma and Allergy Foundation of America
Manufacturer of Current OTC Antihistamines
Phil Walson, M.D., University of Cincinnati, Director of Clinical Trials, Children’s Hospital representing Whitehall Robins (Decided not to present; statement submitted to dockets.)
Bryan Luce, Ph.D., MEDTAP International
Joel W. Hay, Ph.D., Department of Pharmaceutical Economics and Policy, USC and Editor-In-Chief of Value in Health
Steve Francesco, President Francesco International; newsletter SWITCH
Bert Spilker, M.D., Senior Vice President for Science and Regulatory Affairs of the Pharmaceutical Reseearch and Manufacturers of America (PhRMA)
R. William Soller, Ph.D., Senior Vice President and Director of Science and Technology, Consumer Healthcare Products Association (CHPA) (Decided not to present; statement submitted to dockets.)
FDA: Overview Of Today’s Issues
Charles Ganley, M.D., Director OTCDP, outlined the purpose of the meeting.
Petitioner: Blue Cross Presentations were made by:
Robert Seidman, PharmD., M.P.H., Vice President, Wellpoint Health Networks, Pharmacy
Michael Nichol, Ph.D., University of Southern California, School of Pharmacy
Jack Kern, Pharm.D., University of Southern California, School of Pharmacy
Two responses by the sponsors to the Petition:
Francois Nader, M. D., Senior Vice President of Medical and Regulatory Affairs at Aventis
Robert Spiegel, M.D., Sr, V.P. Medical Affairs, Chief Medical Officer; Schering Plough Research
Cazemiro Martin, Division of Over-the Counter Drugs presented the OTC issues and discussed the two ways that a drug can go to the OTC market.
Robert Meyer, M.D., Director, Division of Pulmonary and Allergy Drugs presented a safety review which highlighted the sponsor’s safety data submitted with the NDAs and reviewed the AE reports.
The committee directed the following questions to the sponsors. (Let the record note that Pfizer did not sit in the sponsor section, did not present and did not answer any questions directed to the sponsors.)
The committee asked the sponsors more than once what safety concerns did they think they needed to study
Aventis thought that sub populations needed to be studied as well as comparing doses and comparisons with other antihistamines. No concrete studies underway and no study designs were presented by either company. Another answer was that the sponsor needed to do post-marketing studies but again there was no study design, or study underway – rather the sponsor stated they wanted to collect more data.
A sponsor asserted that allergy landscape has changed and that it is different now then when monograph was written. When asked how the landscape had changed there was no response.
Sponsors were asked why it is so important to oppose it being OTC here when it is sold OTC elsewhere. One answer was it was not really OTC elsewhere – a pharmacist regulated it. This later statement was challenged and it was pointed out that you could buy it in Canada off the shelf.
Questions the FDA asked the Committees to discuss:
Dr. Brass defined that these questions imply that if you answer yes, you can assume that any conceivable label would deal with any safety concerns one could specify.
If one voted no, this meant that the drug was a public health risk and/or the label could not deal with the safety issue so it could be on the OTC market.
Yes = 19 No=4
Yes = 19 No=4
The committee commented on the following two sub questions:
a. If no, what safety or other clinical issues should be addressed prior to OTC marketing?
Those that answered "No" had the following concerns:
Poison control needed to be reviewed, particularly regarding children.
With Loratadine, need to fully understand the QTc and drug -drug interactions before OTC.
Need to demonstrate that they can be used without a learned intermediary
Need dose response curves
Need further studies in the pediatric population
Check data on thrombocytopenia associated with hydroxyzine
Examine data on how this decision will affect access to these products by the medically indigent/underserved.
Those that answered "Yes" added the following caveats about labeling:
It is important to highlight the need to get advice from physician if it is not working
It is important to add statements not to use in renal/hepatic/pregnancy/children under 6 without first consulting with a physician.
With fexofenadine do not market 180 mg dose because it has only been on the market a year.
Add statement that if no relief in a week, go see a learned intermediary
Add statement that it is should not be used for the common cold.
Add statement to see MD if you have asthma before taking the antihistamine
Add precautionary language concerning use by individuals with asthma, seizure disorders, bleeding disorders, and cardiac disorders
Restrict ages to adults (exclude pediatric) and consider putting an upper age limit (eg. 70 years) for sue without physician advice
A verbatim transcript of this meeting will be available on the FDA’s Dockets Management Branch Website approximately 30 days after the meeting. The address is HTTP://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
I certify that I attended the May 11, 2001 meeting of the Nonprescription Drugs Advisory Committee and that these minutes accurately reflect what transpired.
Sandra Titus, Ph.D. Date Eric Brass, M.D., Ph.D. Date
Executive Secretary, NDAC Chair, NDAC