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Pharmaceutical Research Resources

Below you'll find a number of organizations and articles which deal with the pharmaceutical approval process.

Government Agencies

Food and Drug Administration (FDA)
The main Web site for the FDA contains information on all its areas of oversight including product recalls and approvals. Recent news reports on the site include "Limited Use of Cox-2 Inhibitors Recommended."

Center for Drug Evaluation and Research
CDER is the arm of the FDA devoted to monitoring the drug industry and is in charge of approving new drugs for market. It has up-to-date news as well as an archive of documents pertaining to drug information. The site contains an interactive guide to the drug approval process.

Consumer Education: What You Should Know About Buying and Using Drug Products
This section of CDER's Web site provides consumers with information on prescription, generic, and over-the-counter drug products. Visitors can also sign up for email notification of new consumer educational materials on the safe and effective use of medicines .

The FDA's site for drug-related adverse event reporting, with drug safety information and instructions on how to file a report.

Office of Medical Policy Division of Drug Marketing, Advertising, and Communications (DDMAC)
The branch of CDER responsible for overseeing drug advertising. The site contains information on advertising rules, definitions of common terms, FAQs and research reports.

How to Report Problems With Products Regulated by FDA
Step by step instructions from the FDA on how to report problems with products regulated by the agency, including food, prescriptions and over-the-counter medicine, cosmetics, vaccines, blood products and others.

National Institutes of Health: Health Information
The National Institute's of Health maintains a large collection of information on medical conditions and healthy living.

National Institutes of Health: Database provides regularly updated information about federally and privately supported clinical research in human volunteers. gives information about a trial's purpose, who may participate, locations, and phone numbers for more details. The site also offers a background primer on the process of clinical trials.

The National Institutes of Health and the National Library of Medicine maintain an extensive database of news reporting and government information about all health-related topics. The section covers drug and medical safety.

The Centers for Education and Research on Therapeutics
The Centers for Education and Research on Therapeutics (CERTs) is a research program administered by the Agency for Healthcare Research and Quality (AHRQ), in consultation with the Food and Drug Administration, agencies within the United States Department of Health and Human Services (HHS). The mission of the CERTs is to conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products.

Industry and Consumer Groups

American Council on Science and Health: Pharmaceuticals
The American Council on Science and Health (ACSH) is a non -profit consumer education consortium concerned with issues related to food, nutrition, chemicals, pharmaceuticals, lifestyle, the environment and health.

Kaiser Family Foundation: Prescription Drugs: Market and Industry
The Kaiser Family Foundation provides non-partisan information on national health issues to policymakers, the media, and the general public.

Merck Vioxx Information Center
Information on the Vioxx withdrawal from the maker Merck. The collection includes testimony before Congress, clinical study timelines and withdrawal notifications.

Pharmaceutical Research and Manufacturers of America (PhRMA)
The Web site of the pharmaceutical industry's main lobbying organization provides information on new drug treatments, offers its perspective on the issues at hand for drug policy, and offers resources for patients.

Public Citizen's Health Research Group
A non-profit consumer watchdog, the Health Research Group keeps the public informed of the latest drug alerts via its Web site and pressures the FDA on drug safety issues.

The Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research group affiliated with Tufts University. The Center is author of a study which suggests it takes 10-15 years and, on average, $897m to bring a new drug to market.


Dr. Graham's Testimony
Dr. Graham's November 18, 2004 testimony before the Senate Finance Committee.

Statement by Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER)
Text of the FDA/CDER response to Dr. Graham's testimony.

Settlement Sets New Standard For Release Of Drug Information
Press release from the New York Attorney General's office relating to a lawsuit filed by the office relating to the reporting of clinical drug trials by manufacturers.

GlaxoSmithKline settles litigation with New York Attorney General's office
GSK's announcement of the settlement between itself and the New York Attorney General.

Reports and Articles

"The Development of Direct-to-Consumer Prescription Drug Advertising Regulation"
2002 Kaiser Family Foundation study on drug advertising regulation in America.

"Doctor Faults Aggressive Painkiller Ads"
New York Times Syndicate, December 28, 2004

"Fear of bias puts spotlight on drug approval"
Report on 2001 Congressional hearings on the FDA process from the journal NATURE.

FRONTLINE: "Dangerous Prescription"
The extensive companion site to PBS FRONTLINE's late 2003 report on drug approvals contains interviews with FDA officials, scientists and consumer advocates, information on funding of drug studies and other resources. You can view the whole program online.

International Committee of Medical Journal Editors
Web site of the group of medical journals requiring advance submission of clinical trials to a public database before results can be published.

JAMA: Journal of the American Medical Association, December 1, 2004
This issue of JAMA contained several articles and counterpoints addressing the relationship between the pharmaceutical industry and the FDA in the drug approval process.

Additional Sources: THE ECONOMIST, American Council on Science and Health and U.S. Food and Drug Administration Center for Drug Evaluation and Research.

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