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CDER 2007 Update
Introduction
Who we are
The Center for Drug Evaluation and Research is America’s consumer watchdog for medicine. Approximately half of us are physicians or other kinds of scientists. We are part of one of the nation’s oldest consumer protection agencies—the U.S. Food and Drug Administration. The FDA is an agency of the federal government’s Department of Health and Human Services.
Our mission
CDER promotes and protects public health by ensuring that safe and effective drugs are available to Americans. The Food and Drug Administration Act of 1997 affirmed our public health protection role, clarified the FDA’s mission and called for the FDA to:
- Promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of human drugs in a timely manner.
- Protect the public health by ensuring that human drugs are safe and effective.
- Participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements and achieve appropriate reciprocal arrangements.
- Carry out its mission in consultation with experts in science, medicine and public health and in cooperation with consumers, users, manufacturers, importers, packers, distributors and retailers of human drugs.
Our mission was further enhanced on September 27, 2007 when H.R. 3580, the Food and Drug Administration Amendments Act (FDAAA) was signed into law. This new law represents a significant addition to FDA authority and reauthorized the:
- Prescription Drug User Fee Act, allowing FDA to fund reviews of new drugs and shorten review times.
- Medical Device User Fee and Modernization Act which allows FDA to make significant improvements in the medical device review program.
- Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act to encourage more studies to develop treatments for children.
What we do
We evaluate new drugs for safety and effectiveness before they can be sold. Our evaluation, called a review, ensures that the drugs we approve meet our tough standards for safety, effectiveness and quality. Once drugs are on the market, we monitor them for problems.
Reviewing drugs before marketing. FDA does not conduct the clinical studies that support marketing. A drug company seeking to sell a drug in the United States must conduct the studies intended to demonstrate effectiveness and defining the drug’s risks. We monitor clinical research to ensure that people who volunteer for studies are protected and that the quality and integrity of scientific data are maintained. The company then sends us the evidence from these tests to prove the drug is safe and effective for its intended use. We assemble a team of physicians, statisticians, chemists, pharmacologists and other scientists to review the company’s data and proposed use for the drug. If the drug is effective and we are convinced its health benefits outweigh its known risks, we approve it for sale. By setting clear standards for the evidence we need to approve a drug, we help medical researchers bring safe and effective new drugs to American consumers more rapidly. We also review drugs that you can buy over the counter without a prescription and generic versions of over-the-counter and prescription drugs.
Watching for drug problems. Once a drug is approved for sale in the United States, our consumer protection mission continues. We monitor the use of marketed drugs for unexpected health risks. If new, unanticipated risks are detected after approval, we take steps to inform the public and change how a drug is used or even remove it from the market. We monitor changes in manufacturing to ensure they will not adversely affect safety or efficacy. We evaluate reports about suspected problems from manufacturers, health-care professionals and consumers. We try to make sure an adequate supply of needed drugs is always available to patients who depend on them.
Monitoring drug information and advertising. Accurate and complete information is vital to the safe use of drugs. In the past, drug companies promoted their products almost entirely to physicians. More frequently now, they are advertising directly to consumers. We oversee advertising of prescription drugs, whether to physicians or consumers. We pay particular attention to broadcast ads that can be seen by many consumers. The Federal Trade Commission regulates advertising of over-the-counter drugs. Advertisements for a drug must contain a truthful summary of information about its effectiveness, side effects and circumstances when its use should be avoided.
Scientific research. We conduct and collaborate on focused laboratory research and testing. This maintains and strengthens the scientific base of our regulatory policy-making and decision-making. We focus on drug quality, safety and performance; improved technologies; new approaches to drug development and review; and regulatory standards and consistency.
Protecting drug quality. In addition to setting standards for safety and effectiveness testing, we also set standards for drug quality and manufacturing processes. We work closely with manufacturers to see where streamlining can cut red tape without compromising drug quality. To ensure a safe and effective drug supply, we enforce federal requirements for drug approval, manufacturing and labeling. When necessary, we take legal action to stop distribution of products in violation of these requirements. As the pharmaceutical industry has become increasingly global, we are involved in international negotiations with other nations to harmonize standards for drug quality and the data needed to approve a new drug. This harmonization will go a long way toward reducing the number of redundant tests manufacturers do and help ensure drug quality for consumers at home and abroad.
Why we do it
Our goal is to protect and promote the health of Americans. Protecting consumers includes listening to them. We hold public meetings to get expert, patient and consumer input into our decisions. We also announce most of our policy and technical proposals in advance. This gives members of the public, academic experts, industry, trade associations, consumer groups and professional societies the opportunity to comment before we make a final decision. In addition, we take part in FDA-sponsored public meetings with consumer and patient groups, professional societies and pharmaceutical trade associations. These help obtain enhanced public input into our planning and priority-setting practices.
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Date created: July 31, 2008 |
