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FDA Hearings Underscore Need for Clear Policy on Biosimilars

July 12 and 13 hearings of the FDA’s Arthritis Advisory Committee cleared the way for two new biosimilars, adalimumab and etanercept. The committee unanimously supported manufacturers’ applications for the drugs – but that wasn’t the only point of consensus. Participants and even committee members expressed concerns about unfinished regulatory policy and the need to prioritize patient safety.

Senators Urge Action on National Pain Strategy

A bipartisan group of U.S. senators has a question for HHS Secretary Sylvia Burwell: Any progress on the National Pain Strategy? In a letter to Secretary Burwell, 12 senators reiterate the widespread suffering and financial toll of chronic pain. “It is time,” they explain, “to transform the [National Pain Strategy] from a plan on paper to a reality …to improve [Americans’] health and quality of life.”

CMS Models Shake Up Cancer Care

The Centers for Medicare and Medicaid Services’ Oncology Care Model is off and running. As announced during The White House’s cancer summit at Howard University, more than 200 physician practices and 3,200 oncologists have enrolled – effective July 1.

A Reality Check on Health Care Value Models

High drug prices have led to a proliferation of value models that investigate how the United States can control ballooning health care costs. But just how realistic are these models – and their implementation?