-
Is it legal to import medicines into the
U.S. from other countries?
-
What are the drug interactions, side
effects, and/or adverse events associated with
a certain medicine?
-
How do I market an Over-the-Counter (OTC)
drug?
-
How do I report an adverse event?
-
Why are drug prices so high in the United States?
-
Why won’t my insurance company pay for
certain drugs?
-
When will a drug be approved?
-
What is the Investigational New Drug (IND)
process?
-
Are dietary supplements FDA approved?
-
How do I find out when a patent
or marketing exclusivity expires
and when a generic drug will become available?
1. Is it legal to import medicines into the
U.S. from other countries?
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 an 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
importation policy, 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:
http://www.fda.gov/ora/import/ora_import_program.html
You may also find information regarding
concerns of bringing foreign medications into
the U.S. at:
http://www.fda.gov/oc/opacom/hottopics/importdrugs/default.htm
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2. What are the drug interactions, side
effects, and/or adverse events associated with
a certain medicine?
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
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
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/foi/foia2.htm
3. How do I market an Over-the-Counter (OTC)
drug?
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:
http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm.
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/cder/offices/otc/default.htm
and/or CDER Handbook,
http://www.fda.gov/cder/handbook/index.htm.
4. How do I report an adverse event?
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/medwatch/index.html.
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.
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5.
Why are drug prices so high in the
United States?
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
Room 394
Washington, D.C. 20580
Phone: 202-326-3300
Internet:
http://www.ftc.gov
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
Phone: 410-786-3000
http://cms.hhs.gov
6. Why won’t my insurance company pay for
certain drugs?
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_contacts/sid_websites.htm
7. When will a drug be approved?
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 visit
the CDER Handbook at:
http://www.fda.gov/cder/handbook/index.htm
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.
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8.
What is the Investigational New Drug (IND)
process?
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:
http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm
9. Are dietary supplements FDA approved?
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.cfsan.fda.gov/~dms/ds-savvy.html
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.
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10. How do I find out when a patent
or marketing exclusivity expires
and when a generic drug will become 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.fda.gov/cder/ob/: 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:
http://www.fda.gov/cder/ob/faqs.htm
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