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Latest From Cole Werble
FDA is joining the government’s bioresponse and defense efforts to develop small, mobile, on-demand manufacturing systems as next-tech solutions to dwindling domestic supply sources for essential drugs.
How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.
The use of patent “march-in” rights as a tool to control the price of drugs developed with US federal funding support remains substantially less popular with the government-funded research community than with politicians.
HHS is slowly changing its rhetoric on the use of prescription opioids – edging away from crisis to finding positive trends. A new OIG report on opioid use in Medicare Part D emphasizes sustained positive trends in naloxone rescue and medication assisted treatment alternatives to opioid use disorder.
HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.
A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.