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“Medicare isn’t proposing to set prices in Medicare Part B; it already sets prices in Medicare Part B,” said John O’Brien, senior advisor to the HHS Secretary for drug pricing reform. Read More
The FDA will step up enforcement efforts against stem cell clinics in the coming months, Commissioner Scott Gottlieb told participants at the FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C., on Wednesday. Read More
Challengers of brand name drug patents would have to choose between litigating under Hatch-Waxman or through inter partes review under legislation introduced in both the Senate and House on Wednesday. Read More
An HHS audit of the Medicaid program in 2017 found that the federal government lost $1.3 billion in rebates involving 885 misclassified drugs over five years. Read More
Approved NDAs for certain biological products will be deemed to be biologics licenses under new FDA policies beginning March 2020, allowing the products to compete under the biosimilars pathway and potentially lower drug costs. Read More
A coalition of more than 200 healthcare advocacy and biopharma groups warned congressional leaders on Monday of unintended consequences of the Trump administration’s proposal to tie Medicare Part B drug prices to those of foreign countries. Read More