U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.
FDA Commissioner Dr. Scott Gottlieb has quieted many of his critics. An unprecedented level of transparency and public disclosure has garnered support from across the industry.
The Senate is clearing the way this week for a bipartisan bill supported by insurers and provider groups aimed at easing generic drugs' entry into the market, although the legislation's future in the House and Senate is unclear.
Unless Congress changes the law or the FDA changes guidance on biosimilar development, patients and payers can expect to pay exorbitant prices for biologics long after the drugs' patents have expired.
The Institute for Healthcare Improvement, CMS, FDA, Joint Commission and others joined forces to create an action plan that relies on a "total systems approach" to uniformly apply safety principles across the industry.
The FDA claimed 39 drug companies may be blocking generic-drug makers from obtaining samples of their branded products to hinder generic competition.
The FDA is exploring whether it can legally force drugmakers to disclose prices in consumer advertising. President Donald Trump has called the move a key strategy to give companies incentives to keep prices low.
In most transactions, consumers can decide whether price and value are aligned. There's competition, a free flow of information regarding the product, and transparency regarding pricing. Not so with prescription drugs.
The FDA is looking for a "large electronic medical record system" to conduct pharmaceutical safety research.
FDA Commissioner Dr. Scott Gottlieb said tweaking drug rebate laws that favor pharmacy benefit managers could be key to reducing drug prices.
HHS Secretary Alex Azar said HHS is focused on finding solutions for the "lack of negotiating tools" that cause government programs and seniors to overpay for drugs and out-of-pocket costs and lead to "foreign governments free-riding" off U.S. innovation.
As pharmaceutical companies develop digital tools to combat medication adherence issues, the Food and Drug Administration is considering regulating them.