Prescription drug prices for single-source brand name drugs in
the United States are significantly higher than in Canada and other
countries, many of which have price controls. Prices for generically
available drugs tend to be higher in Canada. The price differential
for brand-name drugs between the two countries has led Americans
to purchase upward of US$1 billion in drugs per year from Canadian
pharmacies.
The Food and Drug Administration (FDA (Food&Drug administration)) is an agency of the United
States Department of Health and Human Services and is responsible
for the safety regulation of most types of foods, dietary supplements,
drugs, vaccines, biological medical products, blood products,
medical devices, radiation-emitting devices, veterinary products,
and cosmetics. The FDA (Food&Drug administration) also enforces section 361 of the Public
Health Service Act and the associated regulations, including
sanitation requirements on interstate travel as well as specific
rules for control of disease on products ranging from pet turtles
to semen donations for assisted reproductive medicine techniques.
More details about FDA (Food&Drug administration) :
Leadership
The FDA (Food&Drug administration) is headed by Commissioner Andrew von Eschenbach, who
was confirmed by the Senate on December 7, 2006 after serving
as Acting Commissioner for fourteen months. Von Eschenbach succeeded
Lester Crawford, who resigned on September 23, 2005, just two
months after his final Senate confirmation.
Authorization and regulatory mandate
Most federal laws administered through the FDA
(Food&Drug administration) are codified into the Food, Drug and
Cosmetic Act, also called
Title 21,
Chapter 9 of the United States Code (21 USC 9).The programs for
FDA (Food&Drug administration) safety regulation vary widely
by the type of product, its potential risks, and the regulatory
powers granted
to the agency. For example, the FDA (Food&Drug administration)
regulates almost every facet of prescription drugs, including
testing, manufacturing, labeling,
advertising, marketing, efficacy and safety. It regulates other
products with a set of published standards enforced with a modest
number of facilities inspections.
Funding
Federal budget
The FDA (Food&Drug administration)'s federal budget
request for 2008 totaled $2.1 billion, a $105.8 million increase
from what they received in 2007.
Before the 1990s, the FDA (Food&Drug administration) was funded solely by appropriations
from the federal government. In response to a variety of issues,
Congress adopted various laws in the 1990s that imposed a fee
on entities that applied for FDA (Food&Drug administration) approval of a drug, biologic
or medical device.
User fees
FDA (Food&Drug administration) is also funded by user fees submitted with New Drug Applications
under the Prescription Drug User Fee Act (PDUFA) in which the
industry pays a fee for the review of the new product. A similar
process is used for medical devices under the Medical Device
User Fee and Modernization Act (MDUFMA). These fees may be waived
or reduced for small businesses.
Regulatory Programs
Food and dietary supplements
The Center for Food Safety and Applied Nutrition
is the branch of the FDA (Food&Drug administration) which is
responsible for ensuring the safety and accurate
labeling of nearly all food products in the United States.
One exception is products derived from traditional domesticated
animals, such as cattle and chickens, which fall under the jurisdiction
of the United States Department of Agriculture Food Safety and
Inspection Service. Products which contain minimal amounts of
meat are regulated by FDA (Food&Drug administration), and the
exact boundaries are listed in a memorandum of understanding
between the two agencies. However,
medicines and other products given to all domesticated animals
are regulated by FDA (Food&Drug administration) through a different
branch, the Center for Veterinary Medicine. Other consumables
which are not regulated
by the FDA (Food&Drug administration) include beverages containing
more than 7% alcohol (regulated by the Bureau of Alcohol, Tobacco,
Firearms and Explosives
in the Department of Justice), and non-bottled drinking water
(regulated by the United States Environmental Protection Agency
(EPA)).The Dietary Supplement Health
and Education Act of 1994 mandated that the FDA (Food&Drug
administration) regulate dietary supplements
as foods, rather than
as drugs. Therefore, dietary supplements are not subject to safety
and efficacy testing and there are no approval requirements.
FDA (Food&Drug administration) can take action against dietary supplements only after they
are proven to be unsafe. Manufacturers of dietary supplements
are permitted to make specific claims of health benefits, referred
to as "structure or function claims" on the labels
of these products. They may not claim to treat, diagnose, cure,
or prevent disease and must include a disclaimer on the label.
Bottled water is regulated in America by the FDA
(Food&Drug administration). State governments also regulate
bottled water. Tap water is regulated by state
and local regulations, as well as the United States EPA. FDA
(Food&Drug administration) regulations of bottled water generally
follow the guidelines
established by the EPA, and new EPA rules automatically apply
to bottled water if the FDA (Food&Drug administration) does not
release an explicit new rule. Water bottlers in the US are
subject to inspection similar
to other food firms, but quality controls for the bottled water
industry are not nearly as stringent as those for municipal water
supplies.
Drugs
The Center for Drug Evaluation and Research has different requirements
for the three main types of drug products: new prescription drugs,
generic drugs and over-the-counter drugs. The most rigorous requirements
apply to new prescription drugs.
New prescription drugs
New drugs receive extensive scrutiny before FDA (Food&Drug administration) approval and
some continuing surveillance after marketing. The following sections
outline the basic elements of the regulatory program.
Approval for testing in humans
To test a new drug experimentally in humans, a
sponsor must first file Investigational New Drug Application
(IND). The sponsor
must show it has learned enough about the drug from animal and
laboratory studies to give the drug safely to healthy volunteers.
An IND is automatically approved unless the FDA (Food&Drug administration)
objects. After an initial IND filing, a sponsor must submit annual
reports,
scientific reports about every study conducted and reports of
adverse events.
Approval to market a new drug
A New
Drug Application (NDA)
is request for approval to market a new drug for a specific
indication
or
medical use. The first
pivotal hurdle for approval is the legal requirement for "substantial" evidence
of efficacy demonstrated through controlled clinical trials.
[8] This standard lies at the heart of the regulatory program
for drugs. It means that the clinical experience of doctors,
the opinion of experts, or testimonials from patients, even if
they have experienced a miraculous recovery, have no weight in
this process. The second critical requirement is that the sponsor
must prove the drug is safe "by all scientific means applicable."This
places the burden on the sponsor to conduct whatever tests may
be needed to establish the safety of the drug product.
However, prescription drugs are not completely safe. The legal
requirements for safety and efficacy have been interpreted as
requiring scientific evidence that the benefits of a drug outweigh
the risks and that adequate instructions exist for its safe use.
Many approved medications for serious illnesses (i.e. cancer)
have severe and even life-threatening side effects.
The results of the testing program are codified
in an FDA (Food&Drug administration)-approved public document
that is called the product label, package insert
or Full Prescribing Information. [9]The prescribing information
is widely available on the web, from the FDA (Food&Drug administration),
drug manufacturers, and frequently inserted into drug packages.The
main purpose of
a drug label is to provide doctors with adequate information
and directions for the safe use of the drug.
Chemistry and manufacturing
The FDA (Food&Drug administration) initial review of an NDA also includes a chemical assessment
of the drug molecule. The sponsor must demonstrate a capacity
to manufacture and package the drug at the specified potency
without contamination or impurities and the with specified chemical
characteristics (such as dissolution).
Advertising and promotion
The FDA (Food&Drug administration) reviews and regulates
prescription drug advertising and promotion. (Other kinds of
advertising,
including for over-the-
counter drugs, are regulated by the Federal Trade Commission).
The drug advertising regulation[11] contains two key requirements.
Under most circumstances, a company may only advertise a drug
for the specific indication or medical use for which it was approved.
Also, an advertisement must contain "fair balance" between
the benefits and risks of a drug.
Post market safety surveillance
After approval of an NDA, the
sponsor must review and report to the FDA (Food&Drug administration) every patient adverse
drug experience
of which it
learns. Unexpected serious and fatal adverse drug events must
be reported within 15 days; other events on a quarterly basis.
[12] The FDA (Food&Drug administration) also receives directly adverse drug event reports
through its MedWatch program.[13] These reports are called '"spontaneous
reports" because reporting by consumers and health professionals
is voluntary. While this remains the primary tool of postmarket
safety surveillance, FDA (Food&Drug administration) requirements for postmarketing risk
management are increasing. As a condition of approval, a sponsor
may be required to conduct additional clinical trials, called
Phase IV trials. In some cases the FDA (Food&Drug administration) is requiring risk management
plans for some drugs that may provide for other kinds of studies,
restrictions, or safety surveillance activities.
Generic drugs
Generic drugs are prescription drugs whose patent
protection has expired, and therefore may be manufactured and
marketed by
other companies. For approval of a generic drug, the FDA (Food&Drug administration) requires
scientific evidence that the generic drug is interchangeable
or therapeutically equivalent with the originally approved drug.
Over-the-counter drugs
Over-the-counter (OTC) drugs are biologically active
drugs and combinations that do not require a doctor's prescription.
The
FDA (Food&Drug administration) has a list of approximately 800 approved ingredients that
are combined in various ways to create more than 100,000 OTC
drug products. Many OTC drug ingredients had been previously
approved prescription drugs now deemed safe enough for use without
a physician's supervision.
Biologics and blood products
The Center for Biologics Evaluation and Research is the branch
of the FDA (Food&Drug administration) responsible for ensuring the safety and efficacy of
biological therapeutic agents.[16] These include blood and blood
products, vaccines, allergenics, cell and tissue-based products,
and gene therapy products. New biologics are required to go through
a pre-market approval process similar to that for drugs. The
original authority for government regulation of biological products
was established by the 1902 Biologics Control Act, with additional
authority established by the 1944 Public Health Service Act.
Along with these Acts, the Federal Food, Drug and Cosmetic Act
applies to all biologic products as well. Originally, the entity
responsible for regulation of biological products resided under
the National Institutes of Health; this authority was transferred
to the FDA (Food&Drug administration) in 1972.
Medical and radiation-emitting devices
The Center for Devices and Radiological
Health (CDRH) is the branch of the FDA (Food&Drug administration) responsible for the
premarket
approval of all
medical devices, as well as overseeing the manufacturing, performance
and safety of these devices.[17] The definition of a medical
device is given in the FD&C Act, and it includes products
from the simple toothbrush to complex devices such as implantable
brain pacemakers. The CDRH also oversees the safety performance
of non-medical devices which emit certain types of electromagnetic
radiation. Examples of CDRH-regulated devices include cellular
phones, airport baggage screening equipment, television receivers,
microwave ovens, tanning booths, and laser products.
CDRH regulatory powers include the authority to require certain
technical reports from the manufacturers or importers of regulated
products, to require that radiation-emitting products meet mandatory
safety performance standards, to declare regulated products defective,
and to order the recall of defective or noncompliant products.
The CDRH also conducts limited amounts of direct product testing.
Cosmetics
Cosmetics are regulated by the Center for Food Safety and Applied
Nutrition, the same branch of the FDA (Food&Drug administration) that regulates food. Cosmetic
products are not generally subject to pre-market approval by
the FDA (Food&Drug administration). However, all color additives must be specifically approved
by the FDA (Food&Drug administration) before they can be included in cosmetic products sold
in the U.S. The labeling of cosmetics is regulated by the FDA (Food&Drug administration),
and cosmetics which have not been subjected to thorough safety
testing must bear a warning to that effect.
Veterinary products
The Center for Veterinary Medicine (CVM) is the branch of the
FDA (Food&Drug administration) which regulates food, food additives. and drugs that are
given to animals, including food animals and pets. CVM does not
regulate vaccines for animals, these are handled by the USDA.
CVM's primary focus is on medications that are used in food
animals and ensuring that they do not affect the human food supply.
FDA (Food&Drug administration)'s requirements to prevent the spread of Mad Cow Disease are
also administered by CVM through inspections of feed manufacturers.
On [December 21], 2007, the FDA (Food&Drug administration)
announced plans to create a database to track cloned animals
through the food system and
enable an effective labeling process . This system will be
part of the National Animal Identification System, which will
track all livestock in the United States from farm to fork
Pharmaceutical companies argue that the prices
they set are necessary in order to continue to fund research.
Only
11% of
drug candidates that enter clinical trials are successful and
receive approval for sale. The large cost of conducting clinicals
trials for unsuccessful candidates must be recovered from the
sales of successful drugs, otherwise the discovery and development
of new pharmaceutical drugs would be unsustainable.
The AARP has published a series of studies suggesting
that prescription drug prices are rising significantly faster
than general inflation.[3]
Others have criticized the methodology used as overstating drug
price inflation.
Prescription drug prices, in particular as part
of Medicare, have become a political issue in the United States.
Critics argue
that there is no reason for American consumers to subsidize the
low drug prices in other first-world nations.
It is claimed by the drug companies and Food and
Drug Administration regulators that there is danger to consumers
in using drugs from
Canada.[citation needed] There is scepticism, based on how much
actual risk is involved
Both houses of Congress have passed legislation
to permit imports; but the Bush Administration and the FDA (Food&Drug administration) are
opposed. The anticipated
Medicare reforms, expected to pass, include prescription drug
coverage under Medicare, and there is some interest in Congress
in permitting imports under FDA (Food&Drug administration) regulation.
The large pharmaceutical companies maintain a website at helpingpatients.org
in order to provide drugs at a reduced rate to needy consumers.
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