Regulatory and Washington

BOSTON — A new study of the growing United States opioid epidemic found that deaths from overdoses have nearly doubled over the past seven years, while increasing acute care costs and hospitalizations are taxing health care systems.

ATLANTA — The Centers for Disease Control and Prevention last week upated its 2017-2018 flu season vaccine recommendations.

Vaccine viruses included in the 2017–18 U.S. trivalent influenza vaccines will be an A/Michigan/45/2015 (H1N1)pdm09–like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain these three viruses and an additional influenza B vaccine virus, a B/Phuket/3073/2013–like virus (Yamagata lineage).

WASHINGTON — The final three of nine defendants sued for deceptively marketing dietary supplements will settle charges that the Federal Trade Commission and the State of Maine had filed in February 2017. The agencies charged the defendants with using deceptively formatted radio infomercials and print ads with fictitious endorsers to pitch products they claimed would improve memory and reduce back and joint pain.

WASHINGTON — Hearing aids addressing mild to moderate hearing loss are soon headed to a retail pharmacy near you. President Donald Trump last week signed into law the "FDA Reauthorization Act of 2017," which included the bipartisan Over-the-Counter Hearing Aid Act.

In newspaper ads placed in selected Congressional districts this August, NACDS is thanking members of the U.S. House of Representatives for co-sponsoring the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 109). NACDS also is urging the members of Congress to work toward ultimate passage and enactment of the legislation.

One OTC category expected to emerge in the coming year is hearing aids, which, when paired with in-store hearing aid service centers, will become a powerful solution set. Earlier this year, CVS Pharmacy opened seven hearing stores-within-stores in the Baltimore-Washington, D.C., area, with plans to expand significantly by year’s end.

PARSIPPANY, N.J. — Companies are being more selective in the Rx-to-OTC switches they pursue, Kline & Company  reported in its latest research, the 13th study in its syndicated series, "Rx-to-OTC Switch Forecasts USA: Next Frontier."

In an effort to bring down the price of prescription drugs, the Food and Drug Administration’s new commissioner, Dr. Scott Gottlieb, has made increasing competition among generics manufacturers one of his top priorities. Gottlieb unveiled the Drug Competition action plan in late June. Ahead of a July 18 public meeting, the agency released a list of branded drugs that currently have no listed patents or exclusivities, and also have no generics.