Content about Regulatory and Washington

February 24, 2014

Regional player Lewis Drug has acquired Throndset pharmacies in Jackson and Lakefield, Minn., according to a local news report.

February 21, 2014

Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

February 21, 2014

The Food and Drug Administration will host a public meeting in March to discuss updating the OTC monograph system, the Wall Street Journal reported Friday.

February 19, 2014

The Electronic Retailing Self-Regulation Program recommended that truDERMA discontinue certain claims for the company’s Troxyphen dietary supplement, including claims that the product is “safe and clinically researched.”

February 19, 2014

The Food and Drug Administration announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs.

February 19, 2014

Legislation recently introduced by U.S. Rep. Tom Marino, R-Pa., which is intended to reduce the abuse of prescription drugs by fostering greater collaboration among stakeholders and implementing new safeguards, has received the endorsement of the National Community Pharmacists Association.

February 19, 2014

The West Virginia Senate on Tuesday voted 25-to-9 to make pseudoephedrine a Schedule IV prescription drug and exempt medicines that can’t easily be diverted to methamphetamine, according to published reports.

February 18, 2014

While flu activity declined slightly from the week prior, incidence of influenza-like illness rates remained above the national baseline for the week ended Feb. 8, the Centers for Disease Control and Prevention reported.

February 18, 2014

In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.

February 18, 2014

Now that most generics have declined in cost, plans will look for new ways to control health spend and ensure that generics are being used whenever possible.

February 18, 2014

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.

February 18, 2014

The federal agency in charge of Medicare is pushing for a major overhaul of its Medicare Part D drug benefit program for seniors.

February 18, 2014

The Food and Drug Administration has approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome), which is a rare disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS).

February 14, 2014

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.

February 13, 2014

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.

February 13, 2014

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.

February 13, 2014

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.

February 12, 2014

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.

February 12, 2014

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.

February 12, 2014

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.

February 12, 2014

A coalition of associations representing supplement manufacturers on Tuesday expressed their support of the Designer Anabolic Steroid Control Act of 2014 by Sens. Sheldon Whitehouse, D-R.I., and Orrin Hatch, R-Utah.

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

February 10, 2014

According to last week’s FluView report, released Friday, influenza activity remains elevated nationally.

February 10, 2014

Two Florida lawmakers have introduced legislation in the Florida State Senate and Florida House of Representatives, respectively, that aims to apply standards to pharmacy audits and rein in practices that could negatively impact patient care, small business community pharmacies and state revenue. The legislation has received a nod of approval from the National Community Pharmacists Association.

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