FDA desperately needs an overhaul
by Brian Blase May 09, 2020 06:47 PM The Food and Drug Administration, along with the Centers for Disease Control and Prevention, failed America with its coronavirus response. The CDC bears…
FDA Shouldn’t Keep Safe Drugs off the Market
Congress’s mandate that medications be proved effective is unnecessary and delays potential cures. By : Charles L. Hooper and David R. Henderson March 25, 2020 6:28 pm ET The federal…
Theory, Evidence and Examples of FDA Harm
To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. Additional testing often enhances safety and effectiveness, but requiring…
Cost of Caution: The Impact on Patients of Delayed Drug Approvals
Eric Sun Tomas J. PhilipsonJune 12, 2010Health PolicyFDA Reform The Food and Drug Administration (FDA) has long been judged by how well it balances the goal of safer and more effective prescription…
Delays in Drug Approval Are Deadly, Highlighting the Need for Improved Regulatory Efficiency
Researchers have determined just how many lives are lost when effective investigational drugs are not approved in a timely manner. These delays in the process of anticancer drug approvals result…
Why the FDA Has an Incentive to Delay the Introduction of New Drugs
FDA drug reviewers are immune from legal liability, but they may be reproached and humiliated by congressional hearings, television exposés, and newspaper condemnations. Why don’t congressional representatives, television reporters, and…
FDA policies can kill by delaying approval of effective drugs
Walter E. Williams, Syndicated columnistPublished 11:40 a.m. CT Dec. 24, 2018 Among the U.S. Food and Drug Administration’s responsibilities are approval and regulation of pharmaceutical drugs. In short, its responsibility is…
Study Examines Reasons for Delay, Denial of New Drugs by FDA
EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, JANUARY 21, 2014 Media Advisory: To contact Leonard V. Sacks, M.B.B.Ch., call Sandy Walsh at 301-796-4669 or email sandy.walsh@fda.hhs.gov.Chicago – Several potentially preventable deficiencies, including…
FDA Delay of One Drug Causes 82,000 Lost Life-Years
Reviewed and Critiqued by Stephen B. Strum, MD, FACP, Medical Oncologist Specializing in Prostate Cancer Since 1983November 2010By William FaloonIn 2004, I wrote an article describing how Americans die needlessly because…
Drug Approvals and Deadly Delays
Sam Kazman, J.D. Truth can be stranger than fiction, and bureaucracy can be stranger than metaphor. In 1984 a man named John Nestor became notorious in Washington, D.C., for his…