Frequently Asked Questions About Drugs
No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act and is illegal. Unapproved new drugs are any drugs -- including foreign-made versions of U.S. approved drugs -- that have not been manufactured in accordance with and pursuant to FDA approval.
FDA recognizes that some individuals may seek treatment with an unapproved new drug in a foreign country and may wish to continue such treatment upon their return to the USA. Likewise, FDA recognizes some individuals suffer from conditions for which no FDA approved treatment exist. FDA has developed a guidance that identifies circumstances under which FDA may consider allowing entry of such drugs. Generally referred to as the Personal Import Policy, found in Chapter 9-2 Coverage of Personal Importations, this guidance provides FDA field offices the opportunity to exercise enforcement discretion in allowing entry of drugs when certain criteria are met. These include:
- the drug is unapproved and intended for use for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
there is no known commercialization or promotion of the drug to persons residing in the U.S. by those involved in the distribution of the product;
the product is considered not to represent an unreasonable risk;
the individual seeking to import the product, affirms in writing that it is for the patient’s own use (generally not more than a three-month supply), and provides the name and address of the doctor licensed in the U.S. responsible for his/her treatment with the product, or provides evidence that the product is for the continuation of treatment begun in a foreign country.
This FDA guidance is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S. Even if all of the factors noted in the guidance are present, the drug remains illegal and FDA may determine that such drugs should be refused entry or seized. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind FDA or the public. Most importantly, this policy is not intended to allow importation of foreign versions of drugs that are approved in the U.S.
The homepage of the FDA Import Program is:
You may also find information regarding concerns of bringing foreign medications into the U.S. at: Importing Prescription Drugs
The drug labeling, or package insert, that accompanies drug products, is the most complete single source of information on the drug. They are available from your local pharmacist and are also reprinted in the Physician's Desk Reference (PDR), which can be found in many libraries. In addition, the package insert is available from the manufacturer and may often be found on the drug manufacturer's Web site. Labeling for drugs approved after 1998 may often be found at Drugs@FDA.
Another option for finding additional information on a drug's side effects is to request this through the FDA's Freedom of information Office (FOI). You can find out more about this option and how to make an FOI request at: http://www.fda.gov/RegulatoryInformation/foi/default.htm
Over 100,000 OTC drug products, which contain approximately 700 active ingredients, are currently marketed. OTC drug products are legally marketed in the United States as a result of two types of review by the FDA: OTC drug monograph review or new drug review.
The majority of currently marketed OTC drug products have been evaluated under the OTC drug monograph review. Under this review, the FDA evaluates the active ingredients in products after they have met certain marketing requirements to affirm that they are safe, effective, and properly labeled for their intended uses. This is an active ingredient review, rather than a product-by-product (new) drug review. As a result, the FDA publishes OTC drug monographs that list active ingredients, allowed combinations, and required labeling for classes of OTC drug products (e.g., antacids, cough-cold products). In general, to market an OTC product, the product must meet the standards of the OTC monograph. OTC monographs specify the allowable ingredients, labeling, dosage, etc. for OTC medications. The OTC monographs are published in the Federal Register and may be found at: Status of OTC Rulemakings.
If the product differs from the OTC monograph, it is treated as a new drug. For new (and new generic) OTC drug products, review and approval of a product-specific New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) must occur before marketing is permitted. Products initially marketed as OTC drugs and products initially marketed as prescription (Rx) drug products may be approved under this new drug review.
For additional information about OTC drugs, visit our web site at: http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm093452.htm and "Protecting America's Health Through Human Drugs: Now Available Without a Prescription."
At the FDA, we are interested in learning of adverse experiences that patients encounter, and have implemented the MedWatch program to monitor these experiences. MedWatch is a voluntary system of reporting to FDA any adverse effects and/or product problems. You can find a link to the voluntary reporting form by going to the MedWatch homepage: http://www.fda.gov/Safety/MedWatch/default.htm. Click on "How to Report", then "Reporting by Health Professionals" or "Reporting by Consumers". Alternatively, the direct address is: https://www.accessdata.fda.gov/scripts/medwatch/. Be sure to include the "s" in "https" to ensure access to a secure server.
You can also call the Division of Drug Information at 301-827-4573, and request that a MedWatch Voluntary Reporting Form be sent to you.
The FDA does not have the authority to regulate the prices of drug products in the United States. Manufacturers, distributors, and retailers establish these prices. Since some countries' health care systems are government controlled, such as Canada's, drugs sold in these countries may be considerably less expensive than they are in the United States.
You may wish to contact the Federal Trade Commission (FTC) to voice your concerns on the price of drugs. 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 at:
Federal Trade Commission
Bureau of Competition
Office of Policy and Evaluation
Washington, D.C. 20580
We understand that drug prices have a direct impact on the ability of people to cope with their illnesses as well as to meet other expenses. The FDA, however, has no statutory authority to investigate or control the prices charged for marketed drugs. These prices are established by manufacturers, distributors, and retailers.
Several drug manufacturers have patient assistance programs that will make drugs available to consumers at no cost or at a reduced cost. Financial assistance may also be provided to qualified individuals through the Center for Medicare and Medicaid Services (CMS). To obtain additional information, please contact CMS directly at the following address:
Center for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore MD 21244-1850
The FDA does not stipulate what drugs insurance companies may cover or to what extent the drug may be covered. However, most insurance companies construct their policies in accordance with the labeling of that particular product. The labeling or Patient Package Insert (PPI) of each product is disseminated by the manufacturer, but has been reviewed and approved by FDA. We suggest that you contact your health insurance provider directly to discuss the extent of your coverage for prescription medications. You may also wish to contact the State Insurance Commissioner's Office in your state to discuss your concerns: http://www.naic.org/state_web_map.htm
The FDA is empowered to approve drug products that have been shown to be safe and effective for their labeled use, and we can provide releasable information on products approved for use only in the United States.
FDA requires all drugs to undergo a standard approval process in order to assure that all drugs are safe and effective upon approval. Collecting and reviewing the information necessary to ensure the safety and efficacy of drugs takes a great deal of time. If you would like to read about the drug review process, please visit "Protecting America's Health Through Human Drugs."
If you are seeking information about a drug that is not yet approved, please understand that this information is confidential and belongs to the manufacturer/sponsor developing the drug, so we cannot provide it to the public. You may contact the sponsor directly to inquire about products under development.
A: Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND, or Investigational New Drug application, is the means through which the sponsor technically obtains this exemption from the FDA.
The IND application must contain information in three broad areas:
- Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experiences with the drug in humans (often foreign use).
- Manufacturing Information - Information pertaining to the composition, manufacture, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
- Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators -- professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
For more information about the IND application process, please visit:
In general, the regulation of dietary supplements, vitamins, herbals, botanicals, and natural products were placed under The Center for Food Safety and Applied Nutrition (CFSAN) by Congress in 1994.
The Food and Drug Administration (FDA) does not have any information on dietary supplement products for specific conditions or safety of their use and has not pre-cleared their purported claims. Under the Dietary Supplement and Health Education Act (DSHEA) of 1994, the responsibility for determining the appropriateness of using a dietary supplement lies with the consumer, not the FDA.
You may find some useful information on CFSAN's dietary supplement Web site, "Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information" at http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110567.htm to help sort out the abundant information on dietary supplements. Tips related to basic points consumers should consider, questions to ask health professionals, suggestions for searching the Web or evaluating research, and ways to check common assumptions are available.
Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the Patent and Trademark Office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to a New Drug Application (NDA) applicant if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.
You may find patent and exclusivity information in the electronic Orange Book at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm: search for the drug by name, click on an ‘Application No’, and then click on ‘Patent and Exclusivity Information.’ However, since patents and exclusivities can be issued for many different reasons, it is not possible to tell when a generic will be allowed on the market. You may read more about patents and exclusivity at: Frequently Asked Questions on Patents and Exclusivity.