The FDA and Pharma Regulation
The Food and Drug Administration (FDA) is the regulatory agency which is responsible for creating guidelines regarding the approval and safe use of pharmaceutical products. There are two requirements that must be met before a drug can be approved by the FDA.
1. The pharmaceutical product has to be effective against the disease it is approved for.
2. The pharmaceutical product has to meet specific safety criteria by being subjected to extensive testing involving animals and controlled testing on humans.
It can take several years to obtain an approval by the FDA for any drug or product. Testing which is carried out on animals has to be extensive and it also has to include multiple species. This requirement helps ensure adequate testing to help with the evaluation of the toxicity and effectiveness of the drug. The dosage of any drug that the FDA approves has to fall inside a certain range and the drug has to be proven to produce either a therapeutic effect or a specifically desired outcome. The federal Prescription Drug Marketing Act of 1987 regulates the effectiveness and safety of drugs in the United States.
What exactly does the FDA do to safeguard pharmaceuticals?
The FDA is a public health agency which is both scientific and regulatory. The agency oversees the manufacture, transport, import, sale and storage of nearly $1 trillion worth of pharmaceutical products every year. The FDA is comprised of physicians, pharmacologists, chemists, lawyers, microbiologists and various other professionals. They regulate a wide variety of pharmaceutical products including human and animal products, medical devices, therapeutic agents, radiation emitting products, cosmetics and animal feed. Around a third of the employees at the FDA live outside of the DC area. Investigators and inspectors make visits to over 16,000 facilities annually and make arrangements with state governments and officials to increase the number of facilities being checked. There are also numerous organizations within the FDA which help ensure drug safety.
Center for Drug Evaluation and Research (CDER)
The CDER is one section of the FDA which has the responsibility of assuring the safety and effectiveness of over the counter and prescription drugs. The CDER also evaluates every new drug prior to it being released for sale to the public. They basically serve as a consumer watchdog for over 10,000 drugs that are already on the market to ensure that they continue to meet the safety standards of the federal agency. The CDER also monitors commercials and ads to make sure that they are accurate and truthful about their products. It is also responsible for providing both consumers and health professionals with information about the appropriate use of drugs.
Center for Biologics Evaluation and Research (CBER)
The CBER is the part of the FDA which works on regulating biological products which are used for disease prevention and treatment. These products are much more complex than pharmaceuticals which are chemically synthesized. They regulate products such as blood products, plasma, tests used to screen blood donors and devices that are used to make blood products. They also test products such as vaccines and allergenic products, protein based drugs and products which are used to fight cancer. They also evaluate the effectiveness and safety of biomedical research.
Center for Devices and Radiological Health (CDRH)
The CDRH is in place to regulate new medical devices. In most cases the devices are brand new and must be inspected to ensure their safety and effectiveness long before they reach patients. These types of devices include those which are first-of-a-kind like robotic arms used for surgical procedures, and other types of high-tech devices which are used to prevent, diagnose or treat different diseases such as cancer and heart disease.
Office of Chief Counsel
The Office of Chief Counsel is made up of counselors and litigators. The litigators handle criminal and civil cases; and counselors help provide legal opinions to the different major programs of the FDA. They offer their expert knowledge in matters such which are regulated by the FDA such as food, drugs, devices, biologics, and veterinary products. They are active in rule making procedures, legislative procedures, and policy deliberations and in international negotiations. FDA attorneys are also involved in explaining the various agency programs to Congress, the public and the regulated industry.
1. The pharmaceutical product has to be effective against the disease it is approved for.
2. The pharmaceutical product has to meet specific safety criteria by being subjected to extensive testing involving animals and controlled testing on humans.
It can take several years to obtain an approval by the FDA for any drug or product. Testing which is carried out on animals has to be extensive and it also has to include multiple species. This requirement helps ensure adequate testing to help with the evaluation of the toxicity and effectiveness of the drug. The dosage of any drug that the FDA approves has to fall inside a certain range and the drug has to be proven to produce either a therapeutic effect or a specifically desired outcome. The federal Prescription Drug Marketing Act of 1987 regulates the effectiveness and safety of drugs in the United States.
What exactly does the FDA do to safeguard pharmaceuticals?
The FDA is a public health agency which is both scientific and regulatory. The agency oversees the manufacture, transport, import, sale and storage of nearly $1 trillion worth of pharmaceutical products every year. The FDA is comprised of physicians, pharmacologists, chemists, lawyers, microbiologists and various other professionals. They regulate a wide variety of pharmaceutical products including human and animal products, medical devices, therapeutic agents, radiation emitting products, cosmetics and animal feed. Around a third of the employees at the FDA live outside of the DC area. Investigators and inspectors make visits to over 16,000 facilities annually and make arrangements with state governments and officials to increase the number of facilities being checked. There are also numerous organizations within the FDA which help ensure drug safety.
Center for Drug Evaluation and Research (CDER)
The CDER is one section of the FDA which has the responsibility of assuring the safety and effectiveness of over the counter and prescription drugs. The CDER also evaluates every new drug prior to it being released for sale to the public. They basically serve as a consumer watchdog for over 10,000 drugs that are already on the market to ensure that they continue to meet the safety standards of the federal agency. The CDER also monitors commercials and ads to make sure that they are accurate and truthful about their products. It is also responsible for providing both consumers and health professionals with information about the appropriate use of drugs.
Center for Biologics Evaluation and Research (CBER)
The CBER is the part of the FDA which works on regulating biological products which are used for disease prevention and treatment. These products are much more complex than pharmaceuticals which are chemically synthesized. They regulate products such as blood products, plasma, tests used to screen blood donors and devices that are used to make blood products. They also test products such as vaccines and allergenic products, protein based drugs and products which are used to fight cancer. They also evaluate the effectiveness and safety of biomedical research.
Center for Devices and Radiological Health (CDRH)
The CDRH is in place to regulate new medical devices. In most cases the devices are brand new and must be inspected to ensure their safety and effectiveness long before they reach patients. These types of devices include those which are first-of-a-kind like robotic arms used for surgical procedures, and other types of high-tech devices which are used to prevent, diagnose or treat different diseases such as cancer and heart disease.
Office of Chief Counsel
The Office of Chief Counsel is made up of counselors and litigators. The litigators handle criminal and civil cases; and counselors help provide legal opinions to the different major programs of the FDA. They offer their expert knowledge in matters such which are regulated by the FDA such as food, drugs, devices, biologics, and veterinary products. They are active in rule making procedures, legislative procedures, and policy deliberations and in international negotiations. FDA attorneys are also involved in explaining the various agency programs to Congress, the public and the regulated industry.