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What is FDA

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What is FDAThe Food and Drug Administration (FDA) touches the lives of virtually every American, every day. It’s FDA’s 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. FDA’s budged is $ 1.2 billion, or about $ 4 a year peer taxpayer

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The mission

FDA’s 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.

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The missionFDA 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 (FD&C Act), its amendments, and other public health laws.

The purpose of this legislative framework is to make sure that:

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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)

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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.

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A brief history

1906 Upton Sinclair’s 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

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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.

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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.

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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 agency’s 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.

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Food, Drug and Cosmetic Act (FD&C)

This Act, passed in 1938, remains FDA’s main legal basis. It greatly enlarged the agency’s mission and authority by:

• requiring that new drugs be shown to be safe before marketing. • extending FDA’s 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.

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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 FDA’s regulatory counterparts abroad.

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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.

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How is FDA organized?

FDA is organized into eight offices and program Centers:

Commissioner’s 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 President’s discretion. The Office of the Commissioner oversees all of the Agency’s activities.

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How is FDA organized?

Specialized program CentersFDA is organized into several specialized program Centers that are responsible for protecting the public’s 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

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What is CDER’s 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.

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CDER’s 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 manufacturer’s design (IND) for clinical studies to make sure they will answer important questions about the drug’s 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 product’s safety, effectiveness, and dosage, CDER reviews the results and, if the product’s benefits outweigh its risks, it may approve the drug for marketing (NDA).

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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.

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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.

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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 CDER’s MedWatch, which encourages particularly health professionals to report serious adverse events for the agency’s analysis. If necessary, FDA can take regulatory actions to protect patients that include restrictions on the product’s 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.

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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 product’s manufacturers. The program, which was re-authorized for another 5 years in 1997, has been instrumental in reducing FDA’s median drug review times by more than one-half.

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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 FDA’s expenses connected with generic and non-prescription drugs, plant inspections, post market surveillance, and monitoring of drug advertisements.

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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.

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What is CBER’s mission?

The mission of CBER – FDA’s Center for Biologics Evaluation and Research – is to ensure the safety and effectiveness of biological products for the prevention and treatment of human diseases.

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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.

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Regulating biologics

CBER’s 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.

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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:

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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

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Approving a biologic

Once a biological product is approved, its identity and manufacturing process cannot change without prior FDA approval.

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Blood supply

Assuring the safety of, and the public confidence in, the nation’s blood supply is one of CBER’s 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

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Blood supply – Devices -

It’s 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.

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What is CDRH’s mission

FDA’s 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.

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What is a medical device?

The FD&C 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.

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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.

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Regulatory classes

• Class I – General Controls

Class 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.

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Regulatory classes

• Class II – Special Controls

Class 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 product’s safety. These specific regulations may include requirements for meeting performance standards recognized by FDA, post-market surveillance, patient registries, and other appropriate requirements.

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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.

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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.

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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.

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Continuous analysis

FDA’s 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.

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