Regulatory and Washington

Steel yourself for a strong cough/cold and flu season. Because before the ball even had a chance to drop in Times Square on Dec. 31, the 2017/2018 flu season is already being touted as the strongest on record since the 2009 H1N1 pandemic. According to data released by the Centers for Disease Control and Prevention on Friday, 5.8% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were due to influenza-like illness.

A staunch legislative advocate of the dietary supplement and over-the-counter medicine industries earlier this week announced his retirement from the Senate. On Tuesday, Sen. Orrin Hatch, R-Utah, announced on Twitter that he will not be defending his Senate seat in 2018.

The Food and Drug Administration is moving full speed ahead into the new year, releasing two documents Wednesday as part of its ongoing Drug Competition Action Plan. The documents are aimed at making the generic approval process speedier and reducing the number of review cycles for abbreviated new drug applications, or ANDAs.

It has been announced by the United States subsidiary of Dr.Reddy’s Laboratories, that the company has reached a settlement with the U.S. Government in a case involving packaging for five blister-packed prescription products.

In a joint filing, both parties have agreed to a settlement of the action without any adjudication or issue of fact or law. The matter has been settled for $5 million dollars, and the product in question has not been distributed in the packaging at issue since June 2012, the company said.

The Centers for Medicare and Medicaid Services have released new data from 2016 showing that upward trajectory of U.S. healthcare spending has slowed. The agency, in a report published in the January 2018 issue of Health Affairs that 2016 saw spending increase to 17.9% of U.S. gross domestic product. But that it only grew at a rate of 4.3% — down from the 5.1% and 5.8% spending growth rates seen in 2014 and 2015, respectively.