Department of Health and Human Services DHHS Food and Drug Administration FDA Center for Drug Evalua - PowerPoint PPT Presentation

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Department of Health and Human Services DHHS Food and Drug Administration FDA Center for Drug Evalua

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Title: Department of Health and Human Services DHHS Food and Drug Administration FDA Center for Drug Evalua


1
Department of Health and Human Services
(DHHS)Food and Drug Administration (FDA)Center
for Drug Evaluation and Research (CDER)
  • CDER Drug Shortage Program

2
Drug Shortage Presentation
  • Overview of Drug Shortage Program (DSP)
  • Drug Shortage Management Process
  • Ongoing Issues Related to Shortages
  • Who to Contact

3
CDER Drug Shortage Staff
  • Drug Shortage Program Staff
  • Coordinator (Dr. Mark Goldberger)
  • Drug Shortage Project Managers (CDR Valerie
    Jensen and LCDR Jouhayna Saliba, Christine Moser,
    LT Yon Yu)
  • Network of FDA liaisons
  • -Office of Compliance (Recall Manager/Shortage
    Coordinator)
  • -Office of Generic Drugs (CAPT Harvey Greenberg)
  • -CDER Review Division Contacts
  • -CDER Drug Information (LCDR Larry Lim)
  • -ONDQA Chemistry Consultant (Dr. Eric Duffy)

4
Liaison Roles
  • DSP works closely with the following entities to
    manage shortages
  • - Other Government Entities
  • - Regulated Industry
  • - Professional Associations
  • - International Organizations
  • - Public

5
Reasons for Shortages
  • Bulk drug/API shortage
  • Corporate decisions
  • Manufacturing difficulties/Compliance Issues
  • Market Concentration/Limited Capacity
  • Changes in Clinical Practice
  • Hospital/Pharmacy based issues
  • Emergency Situations (natural disasters/CT
    related)

6
REASONS FOR SHORTAGES
7
Reporting a Shortage
  • Shortages may be reported to CDER Drug Shortage
    Program from the following sources
  • Pharmaceutical companies
  • Professional organizations, healthcare providers,
    patients (through our public e-mail account/phone
    number)
  • Other FDA offices

8
Shortage Management Process
  • Verify that a national shortage exists
  • Communications with pharmaceutical companies,
    wholesaler/distributors
  • Market share data
  • Maintain contact with professional organizations
    to know what is actually happening at the
    hospital/pharmacy level

9
Shortage Management
  • Obtain determination of Medical Necessity (MN)
    from appropriate Review Division(s)
  • CDER Review Division(s) with clinical expertise
    in that area makes decision regarding Medical
    Necessity
  • Off label uses as well as labeled uses are
    considered
  • Investigational drugs can also be medically
    necessary

10
Determination of Medical Necessity
  • Seriousness of the disease
  • Availability of alternatives
  • Role of the firm
  • Consequences of this determination
  • -How proactive we need to be
  • -The potential role of enforcement discretion

11
Definition of a Medically Necessary Product
  • A product is considered to be medically
    necessary, if it is used to treat or prevent a
    serious disease or medical condition, and there
    is no other adequately available source of that
    product or alternative product that is judged by
    medical staff to be an acceptable substitute.
    Inconvenience alone is an insufficient basis to
    classify a product as a medical necessity.

NOTE drug shortages focuses on Medically
Necessary products since they have the greatest
impact on the public health
12
Medical Necessity Determination
  • 2005 data
  • Products evaluated as NMN 32
  • Products evaluated as MN 68

13
Albuterol Inhalers
  • Background CFCs vs. HFAs
  • Federal Register notice
  • One firm exited the CFC market earlier than
    anticipated (30 of mkt)
  • FDA had no advance notice
  • FDA met with all firms to work on short term and
    long term management plan
  • FDA receives weekly inventory updates from all
    firms

14
Albuterol Inhalers (cont.)
  • Working with firms and professional
    organizations, such as ASHP, to make the
    transition from CFC to HFA inhalers as smooth as
    possible
  • HFA inhalers anticipated to increase
    significantly in relation to the CFCs over the
    next year
  • Total albuterol inhalers expected to meet demand
    (no shortage is anticipated)
  • During the transition some patients will need to
    be switched to HFA products
  • FDA Considers CFC and HFA inhalers to be
    clinically interchangeable
  • Post December 31st 2008 only albuterol HFA
    inhalers will be available on the market

15
Methotrexate Injection
  • cGMP issues at manufacturing site
  • Site shut down to upgrade facility
  • 2 firms used the same manufacturing site (both
    hold a significant of overall market)
  • Other suppliers ramped up to cover shortfall
  • One firm supplies the same product for ROW and
    Division expedited approval of NDA and used
    regulatory discretion to allow product with ex-US
    label to be used until US label approved

16
5-Fluorouracil
  • cGMP issue with product (involved glass particles
    in vials)
  • Firm initiated recall of affected lots and
    quarantined all current inventory
  • Oncology Division, Drug Shortage and Compliance
    worked with the firm to resolve issues so
    inventory could be released due to drug shortage
  • Product was released with corrective action (use
    of filter needle with product) due to medical
    need (benefit outweighs the risk)
  • Firm completed long term resolution of problem

17
Shortage Management
  • Facilitate formulation of short term/long term
    plan for shortage management (e.g. Division(s),
    Compliance, Company)
  • Manage communications post information on Drug
    Shortage website, share information with
    pertinent healthcare professional organizations,
    patient groups

18
Actions that can be taken in the Event of a
Shortage
  • Protocol for limited distribution
  • Expedite
  • -Pharm-tox or CMC reviews
  • -Plant inspections
  • -New marketing application (NDA/ANDA)
  • Identify alternate supply sources
  • Request company to continue manufacturing a
    product which they plan to discontinue
  • Encourage other manufacturers to ramp-up
    production
  • Utilize Regulatory Discretion (when benefit
    outweighs any risks involved)
  • Allow temporary imports (RARE)

19
Ongoing Issues Related To Shortages
  • FDA cannot force a manufacturer to produce a
    product
  • Manufacturers are not required to report plans to
    discontinue producing a product unless it is a
    sole source product for a life-supporting/life-sus
    taining condition. (Section 506C of the Food,
    Drug , and Cosmetic Act)
  • Communication/interaction with firms improving

20
Discontinuance Regulation
  • Section 506C of the Food, Drug , and Cosmetic
    Act
  • A manufacturer that is the sole manufacturer of a
    drug that is life-supporting life-sustaining or
    intended for use in the prevention of a
    debilitating disease or condition for which an
    application has been approved under section
    505(b) or 505(j) and that is not a product that
    was originally derived from human tissue and was
    replaced by recombinant product, shall notify the
    Secretary of a discontinuance of the manufacture
    of the drug at least six (6) months prior to the
    date of the the discontinuance
  • Proposed Rule published in Federal Register
    November 7, 2000

21
Ongoing Issues
  • Critical to have advance notice of any potential
    shortage situation (plant closures, cGMP issues,
    import problems)
  • Early determination of impact of shortage (market
    share data, alternate sources)
  • Increasing number of shortages and greater
    public interest
  • Enhance public access to shortage information
    (website, e-mail account, partnership with
    American Society of Health-System Pharmacists and
    other professional organizations)

22
Proactive approaches to preventing shortages
  • FDA
  • -Enhanced product monitoring (Critical Product
    database)
  • -Contacts established and maintained with all
    manufacturers and distributors
  • -Earlier information on potential problems
  • -Interface with trade organizations such as
    GPhA, PDA
  • Industry/Trade organizations
  • -Alternate manufacturing sites
  • -Alternate sources of material
  • -Increased inventories of selected products
  • -Better understanding of available capacity

23
Contacts
  • CDER Drug Shortages
  • CDR Valerie Jensen, LCDR Jouhayna
    Saliba, Christine Moser, and LT Yon Yu
  • Phone (301) 796-1300
  • Email drugshortages_at_cder.fda.gov Web
    address http//www.fda.gov/cder/drug/shortages/d
    efault.htm

24
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