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HHS Eyes Value-Based Drug Pricing, Transparency Policies To Curb Costs

The Obama administration is considering ideas to control drug prices that include contracting with drug makers to pay prices based on performance, employing pharmaceutical cost transparency measures akin to those that some state legislatures have proposed and targeting single-source drugs for price negotiations, according to an HHS official.

Idea Of Government Withholding Protections For High-Priced Drugs Surfaces Again

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FDA's device center chief advocated for the creation of a national device registry as a game-changing way to streamline effectiveness decisions as the agency increasingly shifts some device clinical trial requirements to the post-market arena.

FDA ordered three manufacturers of duodenoscopes, a device that was linked to outbreaks of antibiotic-resistant infections at a Washington hospital and in other health care facilities around the country, to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

A CMS spokesperson tells Inside Health Policy that about 2 percent of subsidized exchange plan members were dually enrolled in Medicaid or CHIP in the states that were able to compare enrollment numbers, which, when using HHS' most recent enrollment figures, equals about 100,000 of approximately 5 million subsidized exchange members in those 27 states.

FDA has accepted for review Sandoz's second biosimilar application, a biosimilar of Amgen's drug Enbrel, a tumor necrosis factor alpha inhibitor, announced parent company Novartis Friday (Oct.2).

FDA is searching for a new director for the Center for Biologics Evaluation and Research, as current Director Karen Midthun is set to retire at the end of the year after working at the agency for 22 years, according to an FDA spokesperson.

Both FDA and groups pushing competing legislative proposals for regulation of laboratory developed tests are holding discussions with academic institutions as a heated debate continues over the agency's oversight plan and legislative alternatives.

Representatives from a major pathology association, the largest lobbying group for medical device manufacturers and FDA faced off last week over the agency’s draft guidance on laboratory developed tests, a discussion that underscored the fierce debate among stakeholders as to the level of oversight required to ensure the safety and accuracy of tests performed in laboratories.

The House Energy & Commerce Committee plans to hold a hearing in October on a revised regulatory proposal to govern laboratory developed tests floated by a working group of large reference laboratories and diagnostic manufacturers, stakeholder sources say.