Regulatory and Washington

From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.

As a result of the patent cliff, generic drug manufacturers have thrived while branded pharmaceutical manufacturers have suffered. Branded pharmaceutical manufacturers are expected to suffer even more in the coming years, as many more important patents will lose exclusivity.

NEW YORK — Lawmakers in Florida are looking into ways to ease regulatory limitations for telemedicine in an effort to increase access to care and create “a fertile ground” for the technology to be used, according to a local report.

MARQUETTE, Mich. — A study released by the Centers for Disease Control establishes that consuming too much added sugar — often found in regular soda, cakes, cookies and candies — significantly increases the risk of death from heart disease.

WASHINGTON — Led by former U.S. Senate Majority Leaders Tom Daschle, D-S.D., and Trent Lott, R-Miss., and former Senator John Breaux, D-La., the Alliance for Connected Care has been launched to promote policy reform around telehealth and remote patient monitoring.

Board members of the Alliance include CVS Caremark, Walgreens, Teladoc, HealthSpot, Doctor on Demand, Welch Allyn, MDLIVE, Care Innovations, Cardinal Health, Verizon and WellPoint.

SILVER SPRING, Md. — After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports. 

Those advisory panels who voted against the change felt the data were insufficient to say naproxen was safer than other NSAIDs.

WASHINGTON — A Medicare proposed rule change limiting the number of prescription drug plans that insurers may offer in the Part D market could require 39% of all enhanced plans to be eliminated in 2016, according to an analysis from Avalere Health that was released Wednesday. The change, which limits standalone PDP sponsors to one basic and one enhanced plan per region, was proposed by the Centers for Medicare and Medicaid Services in a January proposed regulation. 

NEW YORK — The National Advertising Division has recommended that Trinity Sports Group discontinue certain claims for the company’s “NeuroImpact” dietary supplement, including claims that the product has been clinically tested.

NAD noted, however, that the advertiser provided a reasonable basis for “carefully qualified ingredient claims regarding the ability of certain ingredients,” in NeuroImpact “to support healthy brain function.”

ALEXANDRIA, Va. — Members of Congress are contacting the U.S. Centers for Medicare and Medicaid Services in support of pro-patient improvements the agency proposed for Medicare Part D prescription drug plans in 2015, a development applauded today by the National Community Pharmacists Association.

In response to problems with “preferred pharmacy” networks, CMS has proposed allowing any willing pharmacy to offer a plan’s lowest, or preferred, cost-sharing to give seniors more choice and to foster greater competition among pharmacies.