PRESS RELEASE: Pharma Pricing and FDA Updates from Inside Health Policy; Complimentary Trial Subscription Available

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WASHINGTON, DC USA -- PHARMA UPDATE NEWS SERVICE™ -- JANUARY 10, 2019: Sign up for a free trial subscription to Inside Health Policy, the online news service on health care policy from the regulatory reporting experts at Inside Washington Publishers.

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Odds Of Pharma-Backed Part D Measure Passing Are Poor In 2019
It's going to be more difficult for brand drug makers to get Congress to lower their share of seniors' Part D donut-hole costs now that Democrats control the House, and the industry also exposed itself to billions of dollars in offsets while trying to roll back the donut hole policy in 2018, which Congress could use in 2019 to fund other health sector priorities.

International Price Referencing Demo Exposes Patient Advocate Divide
The Trump administration's Medicare Part B international price referencing demo has exposed chasms among groups that call themselves patient advocates, especially on the issues of patient access to medications and the use of value assessments to determine reimbursement levels. Traditionally influential disease-specific groups have largely been critical of the proposal, while a high-profile new drug pricing-focused advocacy organization has put its full-throated support behind the administration.

FDA Guide Outlines Advantages, Disadvantages Of Oncology Endpoints
In an attempt to encourage modernization of clinical trials, FDA revised and replaced its 11-year-old guidance outlining its current thinking on oncology endpoints based on context of use, FDA Commissioner Scott Gottlieb announced Wednesday (Dec. 19).

Booker Drafts Bill To Force Transparency Of Medicaid Drug Board Perks
Sen. Cory Booker (D-NJ) will introduce a bill this week that would require drug manufacturers to report perks given to pharmacists and others who serve on boards that determine which drugs end up on states' Medicaid preferred drug lists, National Public Radio first reported Monday (Dec. 17). The payments can ultimately lead to Medicaid spending more than necessary for some drugs, and paying for medicines that do not fit patients' needs.

Sanders, Khanna Release Drug-Pricing Bill Mixing Trump, Dem Ideas
Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) on Tuesday (Nov. 20) unveiled a prescription drug-pricing bill that blends Republican and Democratic proposals: The legislative plan would expand the Trump administration's international reference pricing concept to span the entire U.S. drug market and includes a Democratic proposal to give the government power to invalidate brand-drug makers' exclusivity if their drug prices are deemed excessively high. Sanders and Khanna plan to introduce the bill in the next session of Congress, which could see more action on drug pricing with a Democratic-led House.

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