Frequently Asked Questions to CDER
- What does the Center for Drug Evaluation
and Research do?
- What drugs are regulated by CDER?
- Are generic drugs the same as brand name drugs?
- Why are some drugs changed from prescription to non-prescription or
over-the-counter (OTC)?
- Does the FDA test drugs?
- Once FDA approves a drug, does this mean that the product is perfectly
safe?
- What questions should I ask my health care provider before taking a new
medication?
- What should I do if I've had a serious side effect to an
over-the-counter or prescription medicine?
- What is required for a drug to be approved by CDER?
- What is a clinical trial?
- How are drugs found?
- What is being done by FDA to gain more information about drugs approved
for adults that doctors also use for children?
- How can I find out about drugs that are currently under review by FDA?
- I've heard that in life-threatening situations, investigational drugs
(those not yet FDA approved) can be obtained. What does this mean?
- Is it legal for me to bring foreign-made medications into the United
States, or have such products mailed to me?
- What can the FDA do about the cost of drugs?
- What should I know before buying medical products online?
- What should I look for on the new over-the-counter medicine label?
Frequently Asked Questions
1. What does the Center for Drug Evaluation and Research do?
The Center is a consumer watchdog in America's healthcare system. CDER's best-known job is
to evaluate new drugs before they can be sold. The Center's review of new drug
applications not only prevents quackery, but it provides doctors and patients with the
information they need to use medicines wisely.
The Center makes sure that safe and effective drugs are available to improve the health
of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name
and generic, work correctly and that the health benefits outweigh known risks.
2. What drugs are regulated by CDER?
From aspirin to cancer treatments, CDER ensures that the benefits of drug products
outweigh any known risks. The Center has oversight responsibilities for prescription,
over-the-counter and generic drugs. This responsibility includes products that many
consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff
shampoos and sunscreens. CDER carefully evaluates the benefits and risks of drugs and
ensures that consumers have access, as quickly as possible, to promising new treatments.
The Center oversees the research, development, manufacture and marketing of drugs. CDER
ensures truth in advertising for prescription drugs and monitors the use of marketed drugs
for unexpected health risks. If unexpected risks are detected after approval, CDER takes
action to inform the public, change a drug's label, or--if necessary--remove a product
from the market. Specifically, CDER regulates:
- Prescription Drugs
Prescription medicines include any drug product that requires a doctor's authorization to
purchase.
- Generic Drugs
A generic drug is a drug product that is equivalent to brand name products in terms of
quality and performance.
- Over-the-Counter Drugs
OTC drug products are available to consumers without a doctor's prescription.
3. Are generic drugs the same as brand name drugs?
FDA works with pharmaceutical companies to assure that all drugs marketed in the United
States meet specifications for identity, strength, quality, purity, and potency. Before
approving a generic drug product, CDER requires many rigorous tests and procedures to
assure that the generic drug can be substituted for the brand name drug.
CDER bases evaluations of substitutability or "therapeutic equivalence" for
generic drugs on scientific evaluations. By law, generic drug products must
contain the identical amounts of the same active drug ingredient as the brand name
product. Drug products evaluated as "therapeutically equivalent" can be expected
to have equal effect and no difference when substituted for the brand name product. FDA
considers drug products to be substitutable if they meet the criteria of therapeutic
equivalence, even though the generic drug may differ in certain other characteristics
(e.g., shape, flavor, or preservatives).
For more information on generic drugs, please visit http://www.fda.gov/cder/consumerinfo/generics_q&a.htm
4. Why are some drugs changed from prescription to non-prescription
or over-the-counter (OTC)?
Some drugs are initially approved as over-the-counter drugs. More often, however,
medications are first approved as prescription drugs and then later switched.
Drugs are commonly switched one of two ways: under an OTC drug review, or by a
manufacturer's submission of additional information to the original drug application.
When considering a prescription to OTC switch, the key question that must be answered
is whether the drug can benefit consumers without endangering their safety.
Nonprescription or OTC drugs are considered safe for consumers to use if they can
easily follow the directions and warnings on the label. To protect consumers, FDA
regulations require that labeling of OTC drugs be written so that ordinary people,
including those with low reading comprehension skills, are able to easily find and
understand information like:
- the intended uses and results of the product
- adequate directions for proper use
- warnings against unsafe use, side effects and adverse reactions.
Toxicity (a drug's potential for poisonous effects) is the major issue in deciding
whether to switch a drug from prescription to OTC. Since almost any drug, if misused, can
have serious side effects, FDA considers the drug's overall safety.
Another consideration in deciding whether or not a drug should be available without a
prescription is whether the condition being treated can be self-diagnosed and recognized
without the help of a health-care practitioner. Not being able to self-diagnose a medical
condition does not automatically prevent a product from switching to OTC status; FDA
evaluates each drug on an individual basis.
5. Does the FDA test drugs?
FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of
a drug's studies so that the Center can evaluate its data. The studies answer the
question: "Does this drug work for the proposed use?" By analyzing the data,
CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be
approved.
6. Once FDA approves a drug, does this mean that the product is
perfectly safe?
No drug product is "perfectly" safe. Every single drug that affects the body
will have some side effects. Since the FDA considers both the benefits and risks of all
medications before approval, side effects are generally not serious. For every drug FDA
approves, the benefits are balanced against its risks. In addition, FDA makes sure the
labeling (package insert) outlines the benefits and risks reported in the tested
population. You and your health-care provider should decide together if the benefits
outweigh the risks for YOU. Talking about your medicines with your health-care provider is
just as important and good for your health as a complete check-up and taking your medicine
as directed.
7. What questions should I ask my health care provider before taking
a new medication?
Before taking a new medication, always ask:
- What is the name of the medication, and what is it for?
- How and when do I take it, and for how long?
- What are the side effects, and what should I do if they occur?
- Is this medication safe to take with other over-the-counter or prescription medication
or dietary supplements that I am currently taking?
If you don't understand the answers, always ask for an explanation.
8. What should I do if I've had a serious side effect to an
over-the-counter or prescription medicine?
Contact your health-care provider right away so that they can advise you on the necessary
actions to take. Also, urge the provider to report the problem to FDA's MedWatch hotline,
at 800-FDA-1088. Your health care provider, however, is not required to report to FDA.
Therefore, consumers can report problems directly. For more information, visit MedWatch.
9. What is required for a drug to be approved by CDER?
Under current law, all new drugs need proof that they are effective and safe before they
can be approved for marketing. No drug is absolutely safe; there is always some risk of an
adverse reaction. CDER decides--as quickly as a thorough evaluation allows--whether the
studies submitted by the drug's sponsor (usually the manufacturer) show it to be safe and
effective for its intended use. When a proposed drug's benefits outweigh known risks, CDER
considers it safe enough to approve. Once a drug gets CDER approval, the drug is on the
market as soon as the firm gets its production and distribution systems going.
10. What is a clinical trial?
A clinical trial is a study conducted to evaluate a drug. Each study is designed to answer
scientific questions and find new and better ways to help people. With any new drug there
are benefits as well as possible risks. There may also be some risks that are not yet
known. Clinical trials help us find out if promising new treatments are safe and effective
for patients. During a clinical trial, more and more information is gained about a new
drug, its risks, and how well it may or may not work. You may be interested in or asked to
enter a trial. Learn as much as you can about the clinical trial before deciding. Only
patients that volunteer take part in a clinical trial.
11. How are drugs found?
The search for new drugs begins with basic research in the laboratory and animal studies.
If this research results in promising findings, then it is continued in patient studies.
This patient research is used to determine how to use new drugs safely and effectively.
12. What is being done by FDA to gain more information about drugs
approved for adults that doctors also use for children?
Every year more than half of newly approved drugs that are likely to be used in children
lack information to permit safe and effective use. Without adequate information, doctors
may be unwilling to prescribe certain drugs for their pediatric patients, or they may
prescribe them improperly. However, if doctors decide against using adult drugs in their
young patients because the proper dose is unknown, children may be deprived of useful
treatments.
To resolve this, FDA finalized regulations, which require manufacturers of many drugs
to provide information about how their drugs can safely and effectively be taken by
children (from newborns to adolescents). This will give health-care practitioners specific
dosing information--based on scientific evidence--which will make prescribing for children
safer and better. Since doctors will have more complete information on how drugs affect
children and what appropriate doses are needed, it enables children to receive better
treatment.
For drugs already approved, FDA can require children's studies to be conducted in
certain circumstances--for example, when pediatric information can help avoid serious
risks to kids. Government regulations allow FDA to waive sending in pediatric data
completely (under certain circumstances), or to submit data after a drug has already been
on the market, if FDA has safety concerns about testing the drug on children prior to
testing it on adults. FDA, however, will not delay approving a drug for adults if the
pediatric studies are not yet completed.
13. How can I find out about drugs that are currently under review
by FDA?
Due to confidentiality rules, FDA is prohibited from releasing information on any drug
under development, review or pending approval unless the information has been made public.
You may contact the manufacturer directly to ask about products under development.
Another possible source of information is the Pharmaceutical Research and Manufacturers
of America (PhRMA).
14. I've heard that in life-threatening situations, investigational
drugs (those not yet FDA approved) can be obtained. What does this mean?
The use of drugs under investigational new drug status is important because it allows
manufacturers to generate data to determine safety and effectiveness in marketing.
However, FDA has established programs to allow patients with an immediately
life-threatening disease "early access" to new treatments. The FDA defines
"immediately life-threatening" as a stage of a disease in which there is a
reasonable likelihood that death will occur within a matter of months, or in which
premature death is likely without early treatment. For example, advanced cases of AIDS and
cancer are considered to be immediately life-threatening diseases.
Since patients who have exhausted standard therapeutic options may be willing to accept
additional risks and potentially dangerous side effects from drug products still under
study, these programs allow patients access to investigational drugs.
A patient's health-care provider should contact the drug manufacturer for information
about product availability for a specific patient if the health-care provider believes
this treatment may be of benefit to their patient. However, FDA is not permitted to
disclose any information regarding investigational drugs, or ask sponsors to provide
investigational drugs to physicians.
15. Is it legal for me to bring foreign-made medications into the
United States, or have such products mailed to me?
The United States Federal Food, Drug and Cosmetic Act prohibits the interstate shipment
(which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs,
including foreign-made versions of U.S. approved drugs that have not received FDA
approval.
FDA has developed a document entitled "Coverage of Personal
Importations" which describes the agency's policy and the circumstances under
which FDA may use discretion and avoid taking legal action against illegally imported
drugs. To find out more about FDA's Import Program visit the Import Information Page.
16. What can the FDA do about the cost of drugs?
We understand that drug prices have a direct impact on the ability of people to cope with
their illnesses as well as meet other expenses. However, FDA has no legal authority to
investigate or control the prices charged for marketed drugs. Manufacturers, distributors
and retailers establish these prices. FDA recognizes that other factors beyond its
purview, including insurance coverage and drug pricing, can determine patient access to
drugs. These factors have been receiving increasing public attention and public debate.
On October 25, 1999, President Clinton directed the Secretary of Health and Human
Services (HHS) to produce the first-ever HHS study of prescription drug costs and trends
for Medicare beneficiaries. This study will investigate price differences for the most
commonly used drugs for people with and without coverage; drug spending by people of
various ages, as a percentage of income and of total health spending; and trends in drug
expenditures by people of different ages, as a percentage of income and of total health
spending. However, the fruits of this research will take some time.
If you cannot afford your prescription medications, we suggest that you:
- Discuss your medication options with your health-care provider to determine if there is
a lower-cost alternative or generic drug available.
- Contact the drug manufacturer. Some drug manufacturers have patient assistance programs
to help patients pay for needed medications.
- Financial assistance may be provided to qualified individuals through the
Centers for Medicare and Medicaid Services (CMS). To obtain additional information, please contact
CMS directly
at:
Department of Health and Human Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850
cms.hhs.gov
For concerns regarding the price of your medications, you should contact the Federal
Trade Commission. 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. You can contact them via the Internet
at: www.ftc.gov.
17. What should I know before buying medical products online?
Although some online pharmacies are legitimate businesses, patients must be cautious
when purchasing drugs over the Internet. Patients should not buy drugs from web sites
that: are not registered on a search engine; offer to prescribe a prescription drug
without a physical exam; sell drugs not approved by FDA; do not offer the opportunity to
ask questions of a registered pharmacist; require that you link to another web site to
purchase the drug; and do not provide an U.S. phone number and address to contact for
questions.
Before buying a prescription drug over the Internet, patients should check with the
National Association of Boards of Pharmacy to see if the online pharmacy possesses a valid
pharmacy license and has met state practice standards. Patients who believe that a web
site is unlawfully selling a drug should report it to the National Association of Boards
of Pharmacy or to the FDA.
For more information on buying medical products online, see the Agency's "Buying Medical Products Online Web Page".
18. What should I look for on the new over-the-counter medicine
label?
The new format will have standardized headings and subheadings using terms that will be
more familiar to consumers. For example, the new label will refer to "uses"
instead of "indications," and it will no longer use the terms
"precautions" or "contraindications." The new label will also require
the information to appear in a standardized order. View sample label
For more information on the OTC label, see CDER's OTC
Label Page.
For additional information about CDER, go to: www.fda.gov/cder/.
You can contact FDA by writing or calling:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Information (HFD-240)
5600 Fishers Lane, Rm. 12B-05
Rockville, MD 20857
1-888-INFO-FDA (1-888-463-6332)
Back to Top
FDA/Center for Drug Evaluation and Research
Last Updated: September 19, 2002
Originator: OTCOM/DML
HTML by SL, PKS, CSA |