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The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it. Read More
Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Read More
“Recent reports analyzing increasing insulin prices have noted a growing difference between a product's average list price and the net price that is ultimately received by the manufacturer,” Collins and Shaheen said. Read More
The FDA granted orphan status to 26 drugs whose applications didn’t include all required information, , according to a Government Accountability Office report released on Friday. Read More
As part of its efforts to contain the opioid epidemic, the U.S. Attorney for the District of Massachusetts issued warnings to opioid prescribers whose patients died of overdoses. Read More
Sen. Jeff Merkley (D-Ore.) introduced the Low Prices Drug Act (S.3680) — a bill that would tie drug prices to drugmakers’ access to Medicare and Medicaid patients and align U.S. drug prices with those in other developed countries. Read More
The FDA announced plans Friday to collaborate with the World Health Organization (WHO) under a pilot program aimed at speeding up reviews of HIV drug applications. Read More
In a wide-ranging analysis of ways to improve access to cancer drugs, the World Health Organization found the drugs remain costly even in countries with strict drug pricing regulations, price transparency is desirable but won’t really address high prices, and initiatives like value-based pricing may not be all that its advocates promise. Read More