Title: Department of Health and Human Services DHHS Food and Drug Administration FDA Center for Drug Evalua
1Department of Health and Human Services
(DHHS)Food and Drug Administration (FDA)Center
for Drug Evaluation and Research (CDER)
- CDER Drug Shortage Program
2Drug 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)
4Liaison Roles
- DSP works closely with the following entities to
manage shortages - - Other Government Entities
- - Regulated Industry
- - Professional Associations
- - International Organizations
- - Public
-
5Reasons 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)
6REASONS FOR SHORTAGES
7Reporting 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
8Shortage 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
9Shortage 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
10Determination 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
11Definition 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
12Medical Necessity Determination
- 2005 data
- Products evaluated as NMN 32
- Products evaluated as MN 68
13Albuterol 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
14Albuterol 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
15Methotrexate 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
165-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
17Shortage 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
18Actions 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)
19Ongoing 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
20Discontinuance 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
21Ongoing 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)
22Proactive 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
23Contacts
- 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
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