Author Archives: Jill Wechsler
By Jill Wechsler | Published: January 30, 2013
The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
By Jill Wechsler | Published: January 28, 2013
In the dog-eat-dog world of federal deficit reduction, there seems to be one health-related spending cut with broad bi-partisan support: require drug companies to give the federal government “a better deal on medications for low-income people on Medicare.” Nearly 70% of respondents back this strategy, according to a survey sponsored by the Kaiser Family Foundation [...]
By Jill Wechsler | Published: January 24, 2013
A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world. The credit goes to public health authorities and medical experts who challenged a provision blocking production of vaccines with the preservative thimerosal, [...]
By Jill Wechsler | Published: January 21, 2013
Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in [...]
By Jill Wechsler | Published: December 12, 2012
If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).