Regulatory and Washington

WASHINGTON — The Council for Responsible Nutrition on Thursday strongly urged the United States International Trade Commission to reject a complaint filed by Amarin Pharma against 18 manufacturers of concentrated EPA omega-3 fish oil.

WASHINGTON — With Congress back from its August recess, lawmakers are making it clear that the fight over the future of the nation’s healthcare system is far from over. Wednesday on Capitol Hill saw the introduction of one bill from each side of the aisle, seemingly diametrically opposed to each other.

The price of drugs — particularly specialty drugs — is the perennial issue plaguing both patients and the companies that make them, as the cost of making a drug, estimated at around $2.6 billion with an average time of 10-15 years, will be factored into the cost of a treatment. Recently, though, patient advocates and regulators have begun acknowledging a need for something to be done about this trend.

WASHINGTON — The Association for Accessible Medicines has rolled out a new video and infographic in support of its campaign for patients to call on their representatives to support legislation supporting the generics industry. The materials outline AAM’s case for passing the Creating and Resorting Equal Access to Equivalent Samples Act.

ATLANTA — The Centers for Disease Control and Prevention is awarding more than $28.6 million in additional funding to 44 states and the District of Columbia to support their responses to the opioid overdose epidemic. The funds will be used to strengthen prevention efforts and better track opioid-related overdoses. This builds upon the July 2017 announcement that CDC was providing $12 million to states to support overdose prevention activities.

INDIANAPOLIS — Eli Lilly and Incyte Corporation on Wednesday announced that, after discussions with the U.S. Food and Drug Administration in late August, Lilly will resubmit the New Drug Application for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data.

NEW YORK — Mayor Bill de Blasio earlier this week signed a series of bills to help reduce the number of smokers in New York City by 160,000 by 2020, in part by banning the sale of tobacco products in retail pharmacy outlets by 2018.