US government agency to investigate FDA over rofecoxib

Rofecoxib, Merck, and the FDA.

The new england journal of medicine 2875 correspondence Rofecoxib, Merck, and the FDA to the editor: Merck has been proactive and conscientious in evaluating the cardiovascular profile of rofecoxib (Vioxx); Dr. Topol's remarks to the contrary in his Perspective article (Oct. 21 issue) 1 are false. First, his description of the time line obfus-cates the facts. The Food and Drug Administration (F...

Failing the public health--rofecoxib, Merck, and the FDA.

On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in hi...

The FDA as a public health agency.

n engl j med 360;24 nejm.org june 11, 2009 2493 Act. The act sought to prevent the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors.” The office initially charged with this responsibility was the Bureau of Chemistry of the Department of Agriculture. Since that time, the bureau has grown into the Food and Drug Adm...

Does the FDA Owe Us an Explanation?

The approval process for new medications sometimes appears to require pharmacokinetic data in some circumstances and clinical trial data in others. This editorial calls for more clarity and transparency in the process and uses three examples to raise the issue.

FDA Reform and the European Medicines Evaluation Agency