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Author Archives: Jill Wechsler
Pharma Pricing Top Target for Medicare Cutbacks
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 [...]
UN Pact Scuttles Anti-Vaccine Provision
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, [...]
Posted in Emerging Markets, FDA, Global, Legal, Market Access, Patient Communication, Safety, healthcare Tagged autism, developing countries, patient advocates, patient groups, thimerosol, vaccines, WHO 1 Comment
Will "Robust Pipeline" Yield More New Drugs?
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 [...]
Posted in Biotech, FDA, R&D, Regulatory, leadership Tagged drug approvals, FDA, John Lechleiter, NME, PhRMA, pipeline, R&D Leave a comment
Temple 'Horrified' by Caronia Decision
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).
Posted in FDA, Marketing, Sales, compliance Tagged Appeals Court, First Amendment, off-label, Robert Temple, sales rep, US v. Caronia 2 Comments
Tom Abrams: Caronia Won't Stop Off-Label Enforcement