Drug Shortages: Frequently
Asked Questions
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 Evaluaion and Research (CBER)
Biological products, including blood and vaccines
Website:
http://www.fda.gov/cber/shortage/shortage.htm
E-mail address for reporting shortages:
CBERProductshortages@cber.fda.gov. Also, during business
hours, biological product manufacturers and healthcare personnel
may report a real or suspected biological product shortage by
calling (301) 827-6220.
-
Center for Food Safety and Nutrition (CFSAN)
Food, including medical foods and cosmetic products
www.cfsan.fda.gov/list.html – 1-888-SAFEFOOD
-
Center for
Veterinary Medicine (CVM)
Food additives and drugs that will be given to animals
CVMHomeP@CVM.fda.gov
-
Center for
Devices and Radiological Health (CDRH)
Medical devices and radiation-emitting products
Dsmica@cdrf.fda.gov – 1-888-463-6332
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 primarily 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 (drugshortages@cder.fda.gov).
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 website 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
Room 394
Washington, D.C. 20580
Phone: (202) 326-3300
Website address:
http://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:
:http://www.ashp.org/s_ashp/index.asp
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Updated: December 15, 2008 |