What is FDA

1
What is FDA
2
What is FDA

• The Food and Drug Administration (FDA) touches
  the lives of virtually every American, every day.
  Its FDAs job to see that medicines and medical
  devices are safe and effective
• FDA is a federal science-based law enforcement
  agency mandated to protect public health. The
  agency has approximately 9.000 employees, most of
  whom are scientists, inspectors, medical doctors,
  and other professionals. FDAs budged is 1.2
  billion, or about 4 a year peer taxpayer

3
The mission

• FDAs mission is to ensure the safety and
  effectiveness of the products under its
  jurisdiction. These products are worth about a
  trillion dollars a year and make up 22 of all
  consumer expenditures.

4
The mission

• FDA accomplishes its mission by establishing and
  enforcing high product standards and other
  regulatory requirements authorized or mandated by
  the Federal Food, Drug and Cosmetic Act (FDC
  Act), its amendments, and other public health
  laws.
• The purpose of this legislative framework is to
  make sure that

5
The mission

• human and veterinary drugs are safe and effective
• there is reasonable assurance of the safety and
  effectiveness of devices intended for human use.
• (cosmetics are safe and properly labeled)
• (public health and safety are protected from
  electronic product radiation)
• (foods are safe, wholesome, sanitary, and
  properly labeled)

6
A brief history
1862 Due to the growing necessity for safe food
and drug products. President Abraham Lincoln
appointed chemist Charles M. Wetherill to head
the chemical division in the newly created
Department of Agriculture. 1883 Chief Chemist
Harvey W. Wiley petitioned for a federal law
prohibiting the adulteration and misbranding of
foods and drugs.
7
A brief history
1906 Upton Sinclairs description of the lack of
hygiene at the Chicago stockyards in his
muckraking novel, The Jungel, prompted
prohibiting interstate commerce in misbranded and
adulterated foods, drinks, and drugs. 1938
Following the death of 107 persons, mostly
children, who took a poisonous Elixir of
Sulfanilamide, Congress greatly strengthened the
public health protection by passing the Federal
Food, Drug and Cosmetic Act
8
A brief history
1962 Dr. Frances Kelsey, an FDA medical officer,
prevented a major tragedy by refusing to allow
the marketing of thalidomide, a s sleeping pill
that lacked sufficient evidence of safety.
Responding to thousand of birth defects that the
drug was causing in Europe and South America,
Congress passed the Kefauver-Harris Amendments
requiring evidence of drug effectiveness as well
as greater safety.
9
A brief history
1976 Congress passed the Medical Device
Amendments that extended the requirements of
safety, effectiveness, and quality control
procedures to medical devices and diagnostic
products. This passage was preceded by a U.S.
Senate report that faulty medical devices had
caused in 10 years 10.000 injuries, 731 of which
were fatal.
10
A brief history
Today FDA implementing the FDA Modernization ACT
of 1997, which was passed by Congress after three
years of FDA scrutiny and covers all of the
agencys activities and programs. With an 80
favorable rating in public polls, the agency is
cooperating with its stakeholders in the U.S. and
aboard to continue protecting consumers and the
public health in the new era of unprecedented
technological and scientific advances.
11
Food, Drug and Cosmetic Act (FDC)

• This Act, passed in 1938, remains FDAs main
  legal basis. It greatly enlarged the agencys
  mission and authority by
• requiring that new drugs be shown to be safe
  before marketing.
• extending FDAs control to cosmetics and
  therapeutic devices.
• authorizing factory inspections and standards of
  identity for food staples.
• eliminating a requirement to prove intent to
  defraud in drug misbranding cases.
• adding court injunctions to the previous
  penalties of seizures and prosecutions.

12
FDA Modernization Act of 1997 (FDAMA)

• In FDAMA, Congress recognized that the protection
  of public health is a responsibility shared by
  the entire health care community. The law directs
  the agency to carry out its mission in
  consultations and cooperation with all FDA
  stakeholders, including consumer and patient
  groups, the regulated industry, health care
  professionals, and FDAs regulatory counterparts
  abroad.

13
Labeling

• In addition to setting product standards, FDA
  regulates the labeling of products under its
  jurisdiction. This information, which must be
  rigorously truthful, well documented, and not
  misleading, plays a major role in protecting
  consumers and the public health. The
  FDA-regulated labeling of drugs and medical
  devices gives pre-scribers and patients reliable
  guidance about the safety and effectiveness of
  health care products.

14
How is FDA organized?

• FDA is organized into eight offices and program
  Centers
• Commissioners office FDA is headed by the
  Commissioner of Food and Drugs who is appointed
  by the President of the United States, confirmed
  by the U.S. Senate, and serves at the Presidents
  discretion. The Office of the Commissioner
  oversees all of the Agencys activities.

15
How is FDA organized?

• Specialized program CentersFDA is organized into
  several specialized program Centers that are
  responsible for protecting the publics health.
• Office of Regulatory Affairs
• Center for Food Safety and Applied Nutrition
• Center for Drug Evaluation and Research
• Center for Biologics Evaluation and Research
• Center for Veterinary Medicine
• National Center for Toxicological Research

16
What is CDERs mission?
CDER Center for Drug Development and Research
makes sure that safe and effective prescription,
non-prescription, and generic drugs are available
to American People as quickly as possible. CDER
fulfills this mission by overseeing the research
, development, manufacture, and marketing of
drugs. It reviews clinical trial evidence of the
safety and electiveness of new drugs before
approving them for marketing monitors their
performance for unexpected health risks and
ensures that drug labeling, drug information for
patients, and drug promotion are truthful,
helpful, and not misleading.
17
CDERs Drug development
Drug development is a highly complicated, lengthy
process that starts with the testing of the
potential medication in vitro in a laboratory and
in animals. When the firm is ready to test the
compound in humans, CDER reviews the
manufacturers design (IND) for clinical studies
to make sure they will answer important questions
about the drugs safety and effectiveness. FDA
monitors the subsequent trials to protect the
rights of the participants and the integrity of
the resulting data. Following the completion of
the required clinical trials that test the
products safety, effectiveness, and dosage, CDER
reviews the results and, if the products
benefits outweigh its risks, it may approve the
drug for marketing (NDA).
18
Good Manufacturing Practices
To make sure that drugs are manufactured to the
same high standards that are required for their
approval, FDA has developed a set of regulations
called the current Good Manufacturing Practices
(cGMPs). The law requires periodic inspections of
all drug firms for compliance with GMPs.
19
Drug safety
Every drug that affects the body has some side
effects. Since FDA approves only those drugs
whose benefits outweigh their risks, the side
effects of properly used drugs usually are not
serious. To further mitigate the potential risks,
FDA includes emphatic warnings about possible
adverse events in the product labeling and the
drug information for patients that is routinely
included with the packaged product.
20
Adverse event reporting
FDA maintains several reporting systems that
alert the agency to side effects that were not
detected during clinical trials, but emerged when
the product became widely used. One of these
programs is CDERs MedWatch, which encourages
particularly health professionals to report
serious adverse events for the agencys analysis.
If necessary, FDA can take regulatory actions to
protect patients that include restrictions on the
products use or its withdrawal from the market.
About 1-3 of products approved each year have
to be removed later because of rare, but serious
side effects.
21
Prescription Drug User Fee Act (PDUFA)
In the Prescription Drug User Fee Act of 1992
(PDUFA) the U.S. Congress, pharmaceutical
industry, and FDA agreed on specific review goals
for certain drugs and biologics, to be achieved
with the help of user fees paid to FDA by the
products manufacturers. The program, which was
re-authorized for another 5 years in 1997, has
been instrumental in reducing FDAs median drug
review times by more than one-half.
22
Prescription Drug User Fee Act (PDUFA)
Today, typical drug applications are processed
by FDA in one year or less priority applications
for breakthrough medications are usually approved
in six months.     PDUFA user fees, however, do
not cover FDAs expenses connected with generic
and non-prescription drugs, plant inspections,
post market surveillance, and monitoring of drug
advertisements.
23
Accelerated Approval
Many of the drugs currently used to treat
life-threatening conditions, such as cancer, were
approved through an accelerated FDA review
process. In accelerated approval, FDA approves
the drug on the condition that the applicant
studies and reports findings of the clinical
benefit of the drug. FDA continues to review new
information and data about these drugs as the
data becomes available. If the findings are
negative, the appropriate actions are taken.
24
What is CBERs mission?
The mission of CBER FDAs Center for Biologics
Evaluation and Research is to ensure the safety
and effectiveness of biological products for the
prevention and treatment of human diseases.
25
What is a biologic, or biological product?
Biological products are made from living
organisms they can be derived from human,
plant, animal, or micro organism
sources. Examples of biological products include
blood, blood components and derivatives, tissues,
allergenic extracts, vaccines, drugs derived from
biotechnology, and certain diagnostic products.
Other examples include somatic cell therapy, gene
therapy or the transplantation of animal organs
or tissues into humans.
26
Regulating biologics

• CBERs activities include
• monitoring the pre-clinical and clinical testing
  of new biological products, and evaluating their
  safety and effectiveness before marketing.
• licensing biological products and manufacturing
  establishments, including blood banks.
• research on AIDS medications, diagnostic tests,
  and vaccines.
• compliance monitoring, lot releasing, and post
  market surveillance.

27
Approving a biologic
CBER staff reviews clinical research and
laboratory testing data to determine if the
biologic is safe and effective for its intended
use. In order for a biological product to be
approved for marketing in the U.S., an applicant
must submit a Biologics License Application
(BLA). The BLA must include information on the
following
28
Approving a biologic

• animal studies and human clinical trials
  performed
• how the biologic is manufactured, processed, and
  packaged, including information on the quality
  control methods used during its manufacture
• labeling that will be used with the product

29
Approving a biologic
Once a biological product is approved, its
identity and manufacturing process cannot change
without prior FDA approval.
30
Blood supply
Assuring the safety of, and the public
confidence in, the nations blood supply is one
of CBERs main priorities. There are five
overlapping safeguards in place to help protect
the safety of blood.

• quarantine of untested blood
• donor screening
• donor deferral registries
• blood testing
• investigations of problems

31
Blood supply Devices -
Its important to note that some of the products
regulated by CBER are devices. These include
products used in the collection and processing of
blood products, such as blood bags, centrifuges,
and test kits that are used to screen donated
blood for infections diseases such as HIV and
Hepatitis.
32
What is CDRHs mission
FDAs Center for Devices and Radiological Health
(CDRH) is responsible for ensuring the safety and
effectiveness of an medical devices and
protecting consumers against harmful man-made
radiation from medical, occupational, and
consumer products.
33
What is a medical device?
The FDC Act defines a medical device as, any
health care product that does not achieve its
principle intended purposes by chemical action or
by being metabolized. Under this definition, a
device can be as simple as a tongue depressor
or a thermometer, or as complex as a kidney
dialysis machine. Medical devices are
classified and regulated according to their
degree of risk to the public.
34
Regulatory classes for devices
Because each device is different, FDA establishes
three different regulatory classes to ensure that
each device is subject to regulations that are
appropriate.
35
Regulatory classes

• Class I General ControlsClass I devices are
  subject to a set of general regulations that
  apply to all devices.General controls include the
  registration of manufactures, general record
  keeping requirements, and compliance with Good
  Manufacturing Practice regulations.

36
Regulatory classes

• Class II Special ControlsClass II devices
  are those for which general regulations are not
  enough to guarantee the safety of the device. A
  Class II device may be subject to specific
  regulations in order to provide assurance of the
  products safety. These specific regulations may
  include requirements for meeting performance
  standards recognized by FDA, post-market
  surveillance, patient registries, and other
  appropriate requirements.

37
Regulatory classes

• Class III Pre Market Approval A device is
  considered Class III if the device is life
  supporting or life-sustaining, or is important in
  preventing impairment of human health. For a
  Class III device, general controls may be
  insufficient to provide reasonable assurance of
  its safety and effectiveness. These products
  require FDA pre-approval before they are
  marketed. Under Class III regulations, devices
  such as heart valves, breast implants, and
  cranial electrotherapy stimulators must be
  reviewed for safety and effectiveness prior to
  marketing.

38
Obtaining FDA Approval
A manufacturer of a Class III device files a
Pre-Market Approval Application (PMA) to obtain
FDA approval to market the product. Like the
submission that is filed for the approval of a
new drug, a PMA contains clinical and laboratory
testing data to demonstrate the safety and
effectiveness of the device.     A pre-market
notification, also known as a 510(k), is an
application submitted to FDA to demonstrate that
a medical device is substantially equivalent to
(i.e., meaning it is as safe and effective as) a
legally marketed device that does not require
pre-market approval.
39
GMPs
FDA further assures the safety and effectiveness
of medical devices by regulating their
manufacture. As with drugs, FDA has established
Good Manufacturing Practices for medical devices.
FDA regularly inspects manufacturers to assure
they comply with these regulations.
40
Continuous analysis
FDAs work does not end when a medical device has
been approved. FDA continuously analyzes reports
to ensure that products are safe and to watch for
dangerous events related to the use of medical
devices. CDRH also monitors certain electronic
products in order to protect the public from
unnecessary exposure to radiation. Products that
are monitored by FDA include televisions,
microwave ovens, x-ray machines, and even the
lasers used in laser light shows. FDA administers
the law by setting and enforcing standards to
limit unnecessary radiation emissions.