Content about Regulatory and Washington

February 25, 2014

The U.S. Preventive Services Task Force on Tuesday posted its final recommendation statement on vitamin, mineral and multivitamin supplements for the prevention of cardiovascular disease and cancer.

WASHINGTON — The U.S. Preventive Services Task Force on Tuesday posted its final recommendation statement on vitamin, mineral and multivitamin supplements for the prevention of cardiovascular disease and cancer. However, the Task Force concluded there is not enough evidence to determine the effectiveness of taking vitamins and minerals to prevent cardiovascular disease or cancer. 

February 24, 2014

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

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

The transaction is expected to take effect April 7 and, according to the Lakefield Standard, Lewis Drug will retain all of the employees.

 

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.

ORLANDO, Fla. — Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl on Thursday 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.

SILVER SPRING, Md. — 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

According to the report, the FDA will consider improving the agency's ability to initiate label changes quickly, allowing for faster innovation from manufacturers and imposing new pediatric dosing limits based on the most recent science. 

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.”

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

As support for the performance and establishment claims at issue, the marketer submitted testing on its key ingredient. After reviewing the evidence, ERSP concluded that truDERMA provided a reasonable basis for claims relating to an “increased sex drive.”

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.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. 

In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

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.

ALEXANDRIA, Va. — 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.

CHARLESTON, W.Va. — 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. A similar bill is being considered by the West Virginia House of Delegates.

According to reports, the two exceptions to the prescription-only requirement would include Acura Pharmaceuticals' Nexafed and Westport Pharmaceuticals' Zephrex-D. 

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.

ATLANTA — 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 Friday. 

Six states were still experiencing high ILI activity, including Arkansas, Connecticut, Kansas, New York, Oklahoma and Texas.

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.

SILVER SPRING, Md. — 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.

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. Prescription drug spending is down, and generic drugs made up 77% of all 2012 prescriptions, according to the Centers for Medicare and Medicaid Services. Could this generic utilization percentage go even higher as a result of recent healthcare legislation?

Medicaid is increasingly becoming a managed care program, and states are looking to entities like pharmacy benefit managers to help them manage their drug spend.

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.

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.

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.

The federal agency in charge of Medicare is pushing for a major overhaul of its Medicare Part D drug benefit program for seniors. Those changes, if adopted, could help level the competitive playing field for pharmacy retailers in Part D plan networks, reduce competitive advantages for preferred pharmacy networks and mail-order pharmacies, and put a tighter squeeze on pharmacy benefit managers.

Thus, the proposals by the Centers for Medicare and Medicaid Services for the 2015 federal fiscal year could spell big changes for retail pharmacies. Among the most far-reaching are:

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).

SILVER SPRING, Md. — 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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.”

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.

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. 

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.

WASHINGTON — 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.

WASHINGTON — The Generic Pharmaceutical Association on Tuesday 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. The bill mirrors current pharmacy practice for interchangeable generic substitution language, and is aligned with Food and Drug Administration definitions, the association noted.

February 10, 2014

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

ATLANTA — According to last week’s FluView report, released Friday, influenza activity remains elevated nationally. Flu activity is likely to continue for several more weeks, the Centers for Disease Control and Prevention concluded.

For the week of Jan. 26 through Feb. 1, the national proportion of people seeing their healthcare provider for influenza-like illness decreased slightly for the fifth week, but remains above the national baseline. All 10 regions continue to report ILI activity above their region-specific baseline level. 

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.

ALEXANDRIA, Va. — 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.