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

Diagnostic Testing

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

Managed Care

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

Professional Associations

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)

Professional Associations

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

Patient Advocacy

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.)

Health Consultants

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

Trade Organizations

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:

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.

  1. Does loratadine have a safety profile acceptable for OTC marketing, i.e., can it be used safely without a learned intermediary?
  2. Yes = 19 No=4

  3. Does fexofenadine have a safety profile acceptable for OTC marketing , i.e., can it be used safely without a learned intermediary?
  4. Yes=18 No=5

  5. Does cetirizine have a safety profile acceptable for OTC marketing , i.e.; can it be used safely without a learned intermediary?

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?

    1. If yes, what statements, related to sedation or any other safety issues should be included in OTC labeling?

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://

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