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Back To Vidyya Information About Drug Shortages

FDA Policy On Combatting Shortages


Introduction

It is FDA's policy to help prevent or alleviate shortages of medically necessary drug products. A drug shortage may involve either an actual or a  potential shortage of a drug product.  Drug shortages occur for a variety of reasons including manufacturing difficulties, bulk supplier problems, corporate decisions to discontinue drugs, and FDA enforcement actions. These drug shortages can have significant public health consequences.

FDA works with all parties involved in drug shortages to make sure all medically necessary products are available within the United States.  Another article "Inside FDA:  When a Drug is in Short Supply" in today's Vidyya provides background information and an example of how FDA manages drug shortages.

The Agency may be alerted to shortage situations by health care professionals, industry, the press, or consumer groups, or through normal FDA surveillance and enforcement activities.  To report a drug shortage , please see the information below.

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Current Drug Shortage Listing
Drug Name Company
Information
Reason for Shortage Related Information
Mestinon (Pyridostigmine).
Timespan
180 mg
ICN Pharmaceuticals;
3300 Hyland Avenue;
Costa Mesa, CA 92626. 
Phone:
(714) 545-0100
www.icnpharm.com
Manufacturing Difficulties Mestinon is currently available through a limited distribution system due to manufacturing difficulties. Patients/Physicians wishing to obtain the product should contact the product manufacturer.
Adagen.
(PEG Adenosine Deaminase)
Enzon, Inc.;
20 Kingsbridge Road;
Psicataway, NJ 08854. 
Phone:
(732) 980-4500
www.enzon.holowww.com
Manufacturing
Difficulties
Adagen is currently available through normal mechanisms. However, current manufacturing difficulties may limit the supply of the product. Patients or physicians wishing to obtain the product should contact the product manufacturer.
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Resolved Drug Shortage Listing
Drug Name Company Information Related Information
Bleomycin Sulfate Injection Faulding Pharmaceutical;
11 Commerce Drive;
Cranford, NJ 07016.
Phone:
(908) 709-1200 
www.faulding.com.au
Bleomycin has been in short supply through some manufacturers. Please note, Faulding Pharmaceuticals has recently been approved as a generic supplier of this product.

Patients/Physicians wishing to obtain the product should contact the product manufacturer.

Factrel (gonadorelin) Wyeth-Ayerst;
P.O. Box 8299;
Philadelphia, PA 19101-8299.
Phone:
(800) 666-7248
www.ahp.com/ahp/wyeth.htm
Factrel is currently available through normal mechanisms. In the past, manufacturing difficulties led to a limited the supply of the product. Patients/Physicians wishing to obtain the product should contact the product manufacturer.
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Drug Shortage Manual of Policies and Procedures (MaPP)

MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.  MaPPs define external activities as well.   All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities, and procedures.

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Medical Necessity Guidance Document

A product is considered to be medically necessary, or a medical necessity, if it is used to treat or prevent a serious disease or medical condition, and there is no other available source of that product or alternative drug that is judged by medical staff to be an adequate substitute. Patient "inconvenience" alone is an insufficient basis to classify a product as a medical necessity.

  • The Guidance for FDA: Process and Criteria for FDA Determination of Medical Necessity.  Describes the Agency policy and procedures to determine the medical need for drug products within the United States with respect to drug shortage management.  This guidance will be available soon.
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How to Report a Drug Shortage
  • Manufacturers:  Contact Michael Verdi (301) 594-2456.
  • Patients, Consumers, and Health Care Professionals:  Contact CDER Drug Information (888) INFOFDA or (888) 463-6332.  You may also call (301) 827-4570.

For background information on reporting drug shortages, please see the CDER Handbook, Drug Shortages page.

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More Information on Drug Shortages, Product Recalls and Warnings

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Editor: Susan K. Boyer, RN
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