Current Drug Shortages: June 2000

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. A 1997 FDA Consumer article "Inside FDA: When a Drug is in Short Supply" 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.

Current Drug Shortage Listing

Adagen (PEG Adenosine Deaminase)
Enzon, Inc, 20 Kingsbridge Rd., Piscataway, NJ 08854. Tel: 732-980-4500.
Manufacturing difficulties: Adagen is currently available through normal channels. However, current manufacturing difficulties may limit the supply of the product.

Bethanechol
Sidmak Laboratories, 17 West St., East Hanover, NJ 07936
Raw materials: As of 6/23/00 Odyssey Pharmaceuticals (a subsidiary of Sidmak) has a supply of Urecholine 25 mg that may be obtained through wholesalers.

Dilantin (phenytoin) Chewable tablets
Parke Davis (Warner-Lambert), 201 Tabor Rd., Morris Plains, NJ 07950. Tel: 800-223-0432.
Manufacturing difficulties: Parke-Davis consumer line reports that this product is currently on drop ship status. An emergency reserve is authorized for shipment directly to pharmacies in quantities of one or two bottles at a time.

Floxuridine Injection
Bedford Laboratories, 300 N. Field Rd., Bedford, OH 44146. Tel: 800-562-4797
Scale up time: Bedford Laboratories is currently limiting distribution of floxuridine injection. The company expects to distribute the product more widely shortly.

Mycobutin (rifabutin)
Pharmacia UpJohn, 100 Route 206 N., Peapack, NJ 07977. Tel: 888-768-5501
Reason unknown: As of 6/21/2000 the Pharmacia UpJohn customer service line reports that this product is in backorder status.

Mesantoin (mephenytoin)
Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936. Tel: 888-669-6682
Discontinued manufacturing: Mesantoin is currently distributed by Novartis under a transition program. Physicians may possibly obtain a small quantity of mesantoin for use in transitioning patients to other anticonvulsant medications.

Mestinon (Pyridostigmine) Timespan 180 mg
ICN Pharmaceuticals, 3300 Hyland Ave., Costa Mesa, CA 92626. Tel: 714-545-0100.
Manufacturing difficulties: Mestinon is currently available through a limited distribution system due to manufacturing difficulties.

Resolved Drug Shortage Listing

Bleomycin Sulfate Injection
Faulding Pharmaceutical, 11 Commerce Dr., Cranford, NJ 07016. Tel: 908-709-1200.
Bleomycin has been in short supply through some manufacturers. Please note, Faulding Pharmaceuticals has recently been approved as a generic supplier of this product.

Factrel (gonadorelin)
Wyeth-Ayerst, P.O. Box 8299, Philadelphia, PA 19101-8299. Tel: 800-666-7248.
Factrel is currently available through normal mechanisms. In the past, manufacturing difficulties led to a limited the supply of the product.

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.

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.

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.

Edited by Angelo DePalma