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Non-Sedating Antihistamines Rx-to-OTC Switch NDAC & PADAC Joint Meeting. May 11, 2001 François Nader, MD Senior Vice-President Medical & Regulatory Affairs, North America Aventis Pharmaceuticals, Inc. Overview.

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non sedating antihistamines rx to otc switch ndac padac joint meeting

Non-Sedating AntihistaminesRx-to-OTC Switch NDAC & PADAC Joint Meeting

May 11, 2001

François Nader, MD

Senior Vice-President

Medical & Regulatory Affairs, North America

Aventis Pharmaceuticals, Inc.

overview
Overview
  • A switch of Allegra® (fexofenadine) from a prescription status to OTC would be premature
  • Allegra is a relatively new product
  • A switch of the 2nd generation antihistamines would be inappropriate, unnecessary, and potentially adverse to the interest of patient safety
  • This process today is unprecedented and unwarranted
  • A switch could have direct and indirect unintended patient safety and public health implications
allegra is still a relatively new product
Allegra® Is Still a Relatively New Product
  • Allegra launches:
    • 1996: Allegra 60 mg bid
    • 2000: Allegra 180 mg qd, Allegra 60 mg tablet Pediatric use -- Allegra 30 mg
  • Ongoing clinical development:
    • Asthma, atopic dermatitis and additional pediatric development
    • The FDA has asked us to assess unanticipated adverse reactions in pediatrics
    • The FDA also asked us to run ECG’s on all pediatric patients included in the trials
  • Ongoing post-approval safety and effectiveness trials
  • Ongoing extensive safety monitoring of the post-marketing experience
seldane over 10 years on the market 24 million patient years experience
Seldane: Over 10 Years on the Market & 24 Million Patient Years Experience
  • Marion Merrell Dow was evaluating the OTC switch of Seldane
  • Neither the company nor the FDA believed there were any significant safety issues associated with the drug
  • Signals on drug-drug interactions leading to serious cardiotoxicity when the drug was not used as labeled
  • Seldane was withdrawn from the US market before it ever went OTC
  • Conclusions:
    • Process, time on the market, and patient exposure are critical
    • Once a drug is sold OTC, the quality and quantity of adverse event reports are no longer reliable
    • A switch would be premature
unprecedented unwarranted switch process
Unprecedented & UnwarrantedSwitch Process
  • Blue Cross has requested extraordinary action with respect to 3 distinct drug products
  • The 3 manufacturers oppose the switch, in part, because of unanswered potential safety and public health questions
  • The non-sedating antihistamines are chemically and pharmacologically different
  • Traditionally, the manufacturer initiates a switch by filing a comprehensive NDA supplement. In this case,
    • No supplement has been filed
    • No studies have been performed
    • No actual OTC use or labeling comprehension studies conducted
  • Limited time and absence of guidance from the FDA
the switch could have unintended patient health and safety consequences
The Switch Could Have Unintended Patient Health and Safety Consequences
  • Difficult for patients to accurately diagnose their condition, identify their triggers, and determine the appropriate course of treatment
  • Impact due to misdiagnosis and co-morbidities
  • Impact on special populations such as pediatrics and the elderly
  • Short-term gain as a result of a shift of medication costs to patients could increase overall healthcare cost substantially
the switch could have unintended patient health and safety consequences7
The Switch Could Have Unintended Patient Health and Safety Consequences
  • The patient, not the doctor, will have to diagnose the condition
  • The patient, not the doctor, will have to select what medications to take and how to take them
  • The patient, not the insurance company, will have to pay for the medications
  • Possible increased use of the less expensive sedating antihistamines
blue cross of california petition
Blue Cross of California Petition
  • No evidence that a switch will benefit patient health and safety
  • Blue Cross argues that the current sedating antihistamines available OTC are “dangerous”
    • Yet, Blue Cross’ own formulary continues to reserve non-sedating antihistamines for patients “who have failed or are unable to tolerate over-the-counter therapy”
    • In fact, the FDA has stated that the sedating antihistamines are safe as currently labeled, and therefore we do not believe there is a basis for the petition in the first place
  • Blue Cross argues that patients are being denied access to non-sedating antihistamines
liability concerns
Liability Concerns
  • Until we have confidence that a switch will not harm patients, we are not prepared to subject physicians, pharmacists, or the company to liability claims based on a premature entry into the OTC marketplace
in summary
In Summary
  • Shifting the diagnosis responsibility, the treatment accountability and the cost burden from managed care to the patients may have direct and indirect patient-safety and public-health implications
  • The patients could be playing a costly trial-and-error game with their health, their quality of life and their money
  • Allergic rhinitis management could switch from a physician driven diagnosis and treatment and a reimbursed medication to a self-diagnosis, a self-chosen treatment and self payment
  • There can be no substitute for a reliable process, time on the market, and patient exposure to characterize rare adverse events in a timely manner
fda questions
FDA Questions
  • Should fexofenadine be made available for OTC use?
    • We believe that a switch would be premature
  • What concerns should be addressed prior to OTC marketing?
    • Continue assessing the post-marketing data
    • Pursue the post-approval clinical trials to further characterize fexofenadine in a prescription environment
    • When timely and appropriate, conduct additional studies to assess the impact of an OTC switch
non sedating antihistamines rx to otc switch ndac padac joint meeting12

Non-Sedating AntihistaminesRx-to-OTC Switch NDAC & PADAC Joint Meeting

May 11, 2001

François Nader, MD

Senior Vice-President

Medical & Regulatory Affairs, North America

Aventis Pharmaceuticals, Inc.

slide13
Switching fexofenadine to OTC would be premature
  • There are no compelling reasons to switch any of the non-sedating antihistamines