FDA Source For Information About Drugs

Questions about CDER

Frequently Asked Questions to CDER

1. What does the Center for Drug Evaluation and Research do?
2. What drugs are regulated by CDER?
3. Are generic drugs the same as brand name drugs?
4. Why are some drugs changed from prescription to non-prescription or over-the-counter (OTC)?
5. Does the FDA test drugs?
6. Once FDA approves a drug, does this mean that the product is perfectly safe?
7. What questions should I ask my health care provider before taking a new medication?
8. What should I do if I've had a serious side effect to an over-the-counter or prescription medicine?
9. What is required for a drug to be approved by CDER?
10. What is a clinical trial?
11. How are drugs found?
12. What is being done by FDA to gain more information about drugs approved for adults that doctors also use for children?
13. How can I find out about drugs that are currently under review by FDA?
14. I've heard that in life-threatening situations, investigational drugs (those not yet FDA approved) can be obtained. What does this mean?
15. Is it legal for me to bring foreign-made medications into the United States, or have such products mailed to me?
16. What can the FDA do about the cost of drugs?
17. What should I know before buying medical products online?
18. 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:

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)

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FDA/Center for Drug Evaluation and Research
Last Updated: September 19, 2002
Originator: OTCOM/DML
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