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Actuaries Warn Against Eliminating The Individual Mandate

Healthcare actuaries are warning Senate leadership against repealing the Affordable Care Act's individual mandate as a part of the Republican tax bill, arguing the repeal could cause increased premiums, fewer insurers to participate in marketplaces and 2018 solvency problems.

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FDA published final guidance on Tuesday (Nov. 21) that lays out how the agency will evaluate generic abuse-deterrent formulations (ADFs) of oral opioids and includes recommendations of the types of studies sponsors should conduct to show the generic ADF is no less abuse-deterrent than its reference listed drug (RLD).

The White House is asking Congress to appropriate $7.6 million in additional FDA funding for hurricane recovery, namely to pay for repair of the agency's offices in hurricane-affected areas.

Amsterdam was chosen Monday (Nov. 20) as the new seat of the European Medicines Agency in the wake of the United Kingdom's earlier vote to exit the European Union.

Patients should be told when co-pays are more than drug cash-prices, according to the American Medical Association.

The new pay system for laboratory tests that CMS published Friday (Nov. 17) mostly ignores the advice of the American Clinical Laboratory Association, and the lobby group is trying to get lawmakers to delay the pay system and make the agency rework it.

FDA is considering how real-world evidence (RWE) can be used to update product labels, and labeling may be the first area in which the agency develops a clear framework for the use of real-world evidence, agency Commissioner Scott Gottlieb told a group of stakeholders during Friends of Cancer Research's (FOCR's) annual meeting.

FDA Commissioner Scott Gottlieb plans to pilot a new hiring process starting in 2018 after an internal report unveiled by Gottlieb Wednesday (Nov. 15) revealed FDA's hiring process needs to be fundamentally redesigned.

The White House Council of Economic Advisors (CEA) announced Monday (Nov. 20) that the U.S. government has underestimated the cost of the opioid crisis, and that in 2015 the economic cost was $504 billion, or over six times more than the most recently estimated cost of the epidemic.

Generic stakeholders are clashing with FDA over what most thought were completed Generic Drug User Fee Amendments (GDUFA II) negotiations, namely the steps sponsors must take to be eligible for priority review.