Drug Shortages: Frequently Asked Questions
October 23, 2003 -- The following questions are those that are most frequently asked of the CDER Drug Shortage Program along with answers.
What is the CDER Drug Shortage Program (DSP)?
This program, within the Center for Drug Evaluation and Research (CDER), was established to address potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health. Through communication, facilitation and negotiation, DSP works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages.
Who handles non-CDER drug shortages?
Center for Biologics Evaluation and Research (CBER)
Biological products, including blood and vaccines, and related drugs and devices
Supervisory Consumer Safety Officer 301-827-6220
Center for Food Safety and Nutrition (CFSAN)
Food, including medical foods and cosmetic products
Center for Veterinary Medicine (CVM)
Food additives and drugs that will be given to animals
Center for Devices and Radiological Health (CDRH)
Medical devices and radiation-emitting products
Why aren't all drugs in short supply listed on the Drug Shortage web page?
The CDER Drug Shortage Program focuses on shortages of medically necessary products since these shortages have the greatest impact on public health. The Drug Shortage page on the FDA website lists shortages of medically necessary products. Shortages that are expected to be resolved quickly or which involve only a particular strength or package size, which has a substitute strength(s) and package size(s), are not usually the focuses of the DSP.
Why are there so many drugs in shortage?
Over the last ten years, the number of shortages has continued to increase. There are many reasons for this increase in shortages and some of the causes are as follows:
- Manufacturing issues -- this may include problems with manufacturing, enforcement activities, raw material shortages, packaging shortages, and other reasons.
- Business decisions may be made by firms to discontinue manufacturing of a drug -- newer products continue to replace older products due to better safety profiles, better efficacy, more convenient dosing regimens, etc.
- Limited manufacturing capacity -- often multiple products are produced on the same equipment which means that an increase in production of one product will usually result in a delay for another product produced on the same production line.
- Market concentration -- as firms discontinue manufacturing of various products, only one or two firms may remain as producers of a product.
How does the CDER Drug Shortage Program find out about shortages?
Often manufacturers will report shortages to FDA although they are not required to do so. Other components within FDA may provide such notification. The DSP also gets reports from healthcare professionals, patients/individuals, or professional organizations using the electronic mail account (email@example.com).
How does the CDER Drug Shortage Program verify that a shortage exists?
The CDER Drug Shortage team utilizes information from manufacturers, distributors and market share data to determine if a shortage exists.
(DSP defines a drug shortage as follows: The total supply of all versions of the approved product available at the user level will not meet the current demand. A registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the user level.)
Once a drug is determined to be in shortage, what happens next?
The DSP consults with the CDER review division that has medical expertise on the drug in shortage to determine whether the drug is a medically necessary drug product. (A medically necessary drug is defined as a product used to prevent or treat a serious or life-threatening disease or medical condition for which there is no other available source of that product, alternative drug or therapy available.) On occasion, expertise from outside the FDA is also obtained to make such a determination. The approved and unapproved ("off-label") uses of a product are taken into consideration.
What can FDA do about drug shortages?
There are many shortage situations over which FDA has no regulatory authority. FDA may, however, do the following:
- Expedite review of submissions from manufacturers -- these submissions may be in support of a marketing application for a new product (NDA or ANDA), or may be in support of manufacturing changes which will allow a product to be available (for example, a chemistry supplement for a new manufacturing site) or may involve other issues (for example, toxicity data for an impurity identified in a product).
- Identify alternate manufacturers that can initiate or ramp-up production.
- Find new/additional sources of raw material.
- Advise/consult with sponsors on resolution of manufacturing issues.
- Allow temporary import of a non-US product, in rare instances.
How long does it take to post a shortage on the FDA drug shortage web site once a report is received that a drug is in shortage?
Once the CDER Drug Shortage Program receives a report of a shortage, verifies that the shortage exists, and receives the determination of a medical necessity for the drug from the review division, Medically Necessary drugs are posted on the drug shortage page. This entire process may take several days to complete.
Can FDA do anything about pricing of medications?
Pricing issues are not within the purview of FDA. However, if you have concerns regarding the price of your medications, you may wish to contact the Federal Trade Commission (FTC). The FTC enforces a variety of federal antitrust and consumer protection laws. The FTC seeks to ensure that the nation's markets function competitively, and are vigorous, efficient, and free of undue restrictions. Contact information for the FTC is as follows:
Federal Trade Commission
Bureau of Competition
Office of Policy and Evaluation
Washington, D.C. 20580
Phone: (202) 326-3300
Website address: www.ftc.gov
Where can I obtain additional information on drug shortages?
The American Society of Health System Pharmacists (ASHP) lists drug shortages and additional information on their website:
Posted: October 2003
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