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CDER Report to the Nation: 1999

Center for Drug Evaluation and Research
Food and Drug Administration
U.S. Department of Health and Human Services

CDER 1999 Report to the Nation

Improving Public Health Through Human Drugs

Adobe Acrobat version of this document



1999 Highlights

1 Drug Review

2 Drug Safety and Quality

3 International Activities

4 Communications


Who we are

The Center for Drug Evaluation and Research is America's consumer watchdog for medicine. We are part of one of the nation's oldest consumer protection agencies-the Food and Drug Administration. The FDA is an agency of the federal government's Department of Health and Human Services. We are the largest of FDA's five centers, with nearly 1,700 employees. Approximately half of us are physicians or other kinds of scientists. Many of us have experience and education in such fields as computer science, legal affairs and regulatory matters.

What we do

Our best-known job is to evaluate new drugs for safety and effectiveness before they can be sold. Our evaluation, called a review, makes sure that the drugs we approve meet our tough standards for safety, effectiveness and quality. We also make sure that you and your doctor will have the information you need to use medicines wisely. Once drugs are on the market, we monitor them for problems.

Reviewing drugs before marketing. A drug company seeking to sell a drug in the United States must first test it. 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 risks, we approve it for sale. We don't actually test the drug when we review the company's data. By setting clear standards for the evidence we need to approve a drug, we help medical researchers bring 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 doesn't stop. 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, change how a drug is used or even remove a drug from the market. We also monitor manufacturing changes to make sure they won't adversely affect the safety or efficacy of the medicine. We evaluate reports about suspected problems from manufacturers, health care professionals and consumers. Sometimes, manufacturers run into production problems that might endanger the health of patients who depend on a drug. We try to make sure that an adequate supply of drugs is always available.

Monitoring drug information and advertising. Accurate and complete information is vital to the safe use of drugs. Drug companies have historically promoted their products directly to physicians. More and more frequently now, they are advertising directly to consumers. While the Federal Trade Commission regulates advertising of over-the-counter drugs, we oversee the advertising of prescription 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. We are monitoring the industry's voluntary program to provide consumers useful information about prescription drugs when they pick up their prescriptions. We are watching this program closely to see that it meets its goals for quantity and quality of information.

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. 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.

Conducting applied research. We conduct and collaborate on focused laboratory research and testing. Research 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.

Why we do it

Our present and future mission remains constant: to ensure that drug products available to the public are safe and effective. Our yardstick for success will always be protecting and promoting the health of Americans.

Getting consumer input. Protecting consumers means listening to them. We routinely consult the American public when making decisions about the drugs that they use. We hold public meetings about once a week to get expert, patient and consumer input into our decisions. We also announce many of our proposals in advance. This gives members of the public, academic experts, industry, trade associations, consumer groups and professional societies the opportunity to comment and make suggestions before we make a final decision. In addition, we take part in a series of FDA-sponsored public meetings with consumer and patient groups, professional societies and pharmaceutical trade associations. These stakeholder meetings help us obtain enhanced public input into our planning and priority-setting practices.

What is a drug?

We regulate drugs used to treat, prevent or diagnose illnesses. However, drugs include more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs." You can buy some drugs in a store without a prescription, while others require a doctor's prescription. Some are available in less-expensive generic versions.

Prescription drugs

Prescription medicines must be administered under a doctor's supervision or require a doctor's authorization for purchase. There are several reasons for requiring a medicine be sold by prescription:

  • The disease or condition may be serious and require a doctor's management.
  • The medicine itself may cause side effects that a doctor needs to monitor.
  • The same symptoms can be caused by different diseases that only a doctor can diagnose.
  • The different causes may require different medicines.
  • Some medicines can be dangerous when used to treat the wrong disease.

Over-the-counter drugs

You can buy OTC drugs without a doctor's prescription. You can successfully diagnose many common aliments and treat them yourself with readily available OTC products. These range from acne products to cold medications. As with prescription drugs, we closely regulate OTC drugs to ensure that they are safe, effective and properly labeled.

Generic drugs

A generic drug is a chemical copy of a brand name drug. There are generic versions of both prescription and over-the-counter drugs. Generic drugs approved by the FDA have the same therapeutic effects as their brand name counterparts. Brand name firms, as well as generic firms, make generic drugs. The biggest difference between a generic drug and its brand name counterpart is usually price. A generic drug may be priced anywhere between 20 percent and 75 percent of the cost of the brand name version.

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1999 Highlights

We are pleased to present our fourth performance report. Our work last year offered many Americans new or improved choices for protecting and maintaining their health or new ways to use existing products more safely. We began the process of engaging our stakeholders in a national effort to improve the nation's multicomponent, complex system for managing the risks and benefits associated with using medicines.

Drug Review

Children, older Americans at risk for stroke, people with rare disorders, Parkinson's disease, cancer and AIDS all benefited from significant new drugs approved in 1999. We met our obligations to the pharmaceutical industry for prompt and thorough review of drug applications supported by user fees. Our reviews of generic drugs have been prompt and predictable despite the growing complexity of drugs coming off patent. We approved 83 new drugs, including 35 new molecular entities. New molecular entities contain an active substance never before approved for marketing in any form in the United Sates. We also approved 97 new or expanded uses of already approved drugs, four over-the-counter drugs and 186 generic drugs.

Drug safety and quality

All medicines have risks. Injuries from approved medicines may rank among the top 10 causes of death in the United States. With modern, state-of-the-art tools and techniques, we are able to detect rare and unexpected risks more rapidly and take corrective action more quickly. With our colleagues in the FDA's other medical product centers, we conducted a study of the system that has evolved in this country to maximize the benefits of the use of medicines and minimize their risks. We trained our own staff on modern methods of risk management and began the process of using our influence to begin a dialogue with other components of the system.

International activities

We worked closely with our colleagues in Japan and the European Union on finding ways to make the drug development process more efficient and uniform. Our goal is to shorten drug development times, while learning the most, to make new medicines available with minimum delay. We neared completion of a common technical document that can be used to submit a marketing application in all three regions. We began the first year of a three-year implementation process for the Mutual Recognition Agreement with the European Union. This agreement will allow reciprocal reliance on inspections of pharmaceutical manufacturing plants.


We continued our efforts begun in 1998 to include greater input into our planning and decision making from consumers, patients, health-care professionals, academia and industry. We revamped our Internet site to make it more interactive and intuitive to use. We include cross-linked information on all new medicines approved since January 1998. This includes plain language information for consumers and technical information for health professions.

We executed the first phase of an information campaign to introduce the public to the new over-the-counter drug labels. We remain a trusted and reliable source of information on drugs. We had thousands of contacts with members of the public, health professional, sate and local public health officials and the industry.

Y2K drug shortage assurance

We surveyed the pharmaceutical industry on their preparedness for the Y2K transition and launched a successful information campaign to allay public fears of drug shortages.

Antibiotic resistance

We play an active role on FDA's antibiotic resistance coordinating committee to address the growing problem of antibiotic resistance and its effects on drug development and regulation. We are developing approaches to provide education and information on the appropriate use of antibiotics to health care professionals and consumers.

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Scientific Research

We focus on advancing the scientific basis of regulatory policy by developing new scientific methods and regulatory testing paradigms and by providing scientific support for the development of regulatory policy. We have focused specifically on creating tighter linkage between nonclinical and clinical studies, enhancing the methodology for assuring product quality, building databases for improved drug development and review and providing regulatory support through laboratory testing.

We continue to seek ways to leverage our scientific resources. We collaborated with a scientific professional society and pharmaceutical trade associations to create the Product Quality Research Institute as a nonprofit corporation. The institute will bring our scientists together with those from academia and industry to identify better test methods for assessing the quality of drugs and to improve manufacturing and management processes.

Other key scientific achievements include:

  • Streamlining the productivity of laboratory programs that are used as an important analytical part of the new and generic drug review process.
  • Refocusing our metabolism research program to examine liver toxicity issues.
  • Developing behavioral assessments and noninvasive imaging techniques to detect and predict drug induced toxicity to the nervous system.
  • Investigating practical biomarkers to detect and predict drug-induced damage to blood vessels.
  • Developing improved animal models and skin biomarkers for drug-enhanced tendency to develop skin cancer.
  • Strengthened support for alternative transgenic mouse models that take less time to test the cancer-causing potential of drugsEnhancing our computational toxicology software to improve drug safety and provide better support to the drug development and review process.

Scientific excellence

We received the 2000 FDA Scientific Achievement Award for developing and implementing a guidance that established a mechanistic basis for correlating in vitro drug product dissolution and in vivo bioavailability. The award recognizes the importance of collaboration between research and review staff to establish policy.

Alternative methods for toxicology testing

Last year, we assumed leadership of FDA's participation on the Interagency Coordinating Committee on the Validation of Alternative Methods. The committee, with representatives from 14 federal regulatory and research agencies, works on the validation, acceptance and harmonization of toxicological test methods. This process serves our needs for responding to alternative testing initiatives and provides a mechanism to interact with developers of such tests.

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