The U.S. Court of Appeals just delivered another blow to a rather-clever-but-cunning play by Allergan, the pharmaceutical giant, to game the patent system.
FDA
Can the FDA's tactics – to impact the current opioid problem – also predict its successor? The goal is to head off escalation before problems are crises, and the move is a departure from the status-quo, reactive nature of prior policies.
The ubiquitous, on-screen advertising about prescription drugs is highly structured by the FDA. That helps explain why the voice-over's claims and cautions are delivered so quickly at the end of the commercial.
Society often pathologizes normal development. When this is done, a medicine must be made for treatment (needed or not). The FDA recently called out a group of over-the-counter drugs for being harmful and without benefit for infant teething.
Using patient safety as a bargaining chip, and a tactic of delay, is unseemly at best and immoral at worst.
Question: Does the deletion a gene make an organism genetically modified? Answer: Not if the organism is a plant – only if it's an animal. The contradictions of that definition are now a subject of congressional concern.
Commissioner Scott Gottlieb believes that his FDA should be in the business of getting smokers to transition away from cigarettes, to something less harmful like e-cigarettes or other products. That's similar to the policy taken by the UK's National Health Service, and it's precisely in line with ACSH's policy stance of harm reduction.
Did you know that in an emergency you could be enrolled in a clinical trial without your consent? How is this possible and what can you do about it?
Intermountain Health, a Utah-based non-profit, announced it will be leading an effort that controls 450 U.S. hospitals to make a strategic play in the generic drug market. But will fighting a consolidated industry with consolidation reduce drug costs?
Can you hear Ho, Ho, Ho from the halls of the FDA? We can! They are playing Santa this year, helping to make one of our Christmas wishes come true. That's by bringing the gift of stopping people from getting harmed by homeopathic remedies.
When it comes to medical developments, it was an exciting year in the pursuit of what was once impossible. Here are some top picks that genuinely are changing the medical and tech landscape.
When words like "world-renowned" are used in the medical realm (especially by people selling something, like an unnecessary product or procedure), beware. And then prepare yourself with a healthy dose of skepticism.