Content about Regulatory and Washington

March 26, 2014

CVS Caremark has been awarded a three-year contract to provide integrated PBM for the Blue Cross and Blue Shield Government-wide Service Benefit Plan, also known as the Federal Employee Program.

WOONSOCKET, R.I. — CVS Caremark has been awarded a three-year contract to provide integrated PBM for the Blue Cross and Blue Shield Government-wide Service Benefit Plan, also known as the Federal Employee Program.

March 26, 2014

GlaxoSmithKline began alerting consumers that some bottles of its Alli over-the-counter weight-loss medication have been tampered with.

MOON TOWNSHIP, Pa. — GlaxoSmithKline on Wednesday began alerting consumers that some bottles of its Alli over-the-counter weight-loss medication have been tampered with. "Consumer safety is GSK's primary concern," the company stated. "We have initiated an investigation and are working with the Food and Drug Administration."

The outer carton of any tampered product may look authentic, but there are several tell-tale signs that the product has been tampered with, GSK cautioned, including:  

March 26, 2014

Message to federal health plan payers from community pharmacy: We have the systems in place and the professional expertise to help millions of patients to better their health outcomes at a lower cost. Message to pharmacy from the U.S. Department of Health and Human Services and its Centers for Medicare and Medicaid Services: Prove it.

Message to federal health plan payers from community pharmacy: We have the systems in place and the professional expertise to help millions of patients to better their health outcomes at a lower cost. Message to pharmacy from the U.S. Department of Health and Human Services and its Centers for Medicare and Medicaid Services: Prove it.

March 25, 2014

The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL.

SILVER SPRING, Md. — The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL. 

Atovaquone is the generic equivalent of GlaxoSmithKline's Mepron, indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

March 25, 2014

Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution.

PITTSBURGH — Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's abbreviated new drug application for this product infringed four Mylan patents covering Perforomist.  

The court's decision prevents Teva's ANDA, which has yet to receive a tentative approval from the Food and Drug Administration. 

March 24, 2014

As the March 31 enrollment deadline draws near, CVS/pharmacy and Ralphs grocery chain have inked deals with the Covered California exchange to promote the healthcare law inside their retail outlets, the Los Angeles Times has reported.

LOS ANGELES — As the March 31 enrollment deadline draws near, CVS/pharmacy and Ralphs grocery chain have inked deals with the Covered California exchange to promote the healthcare law inside their retail outlets, the Los Angeles Times has reported.

March 21, 2014

Advanced Care Scripts, a division of Omnicare Specialty Care Group, on Friday announced that it has been awarded specialty pharmacy accreditation from URAC, a Washington, D.C.-based healthcare accrediting organization.

ORLANDO, Fla. — Advanced Care Scripts, a division of Omnicare Specialty Care Group, on Friday announced that it has been awarded specialty pharmacy accreditation from URAC, a Washington, D.C.-based healthcare accrediting organization. URAC offers one of the only third-party, voluntary accreditation programs of this scope for the pharmacy benefit management and prescription services industries.  

March 21, 2014

Rx Response earlier this week established a new membership structure that will enable individual companies in the bio-pharmaceutical supply chain to become direct members.

WASHINGTON — Rx Response earlier this week established a new membership structure that will enable individual companies in the bio-pharmaceutical supply chain to become direct members.

March 20, 2014

The Consumer Healthcare Products Association on Wednesday released the results of a recent poll of Missouri voters conducted by GS Strategy Group and supported by CHPA that found a clear majority of state residents oppose proposed legislation that would require a prescription for the purchase of pseudoephedrine.

WASHINGTON — The Consumer Healthcare Products Association on Wednesday released the results of a recent poll of Missouri voters conducted by GS Strategy Group and supported by CHPA that found a clear majority of state residents oppose proposed legislation that would require a prescription for the purchase of pseudoephedrine.

March 20, 2014

Mallinckrodt, a specialty pharmaceuticals company, announced the completion of its acquisition of Cadence Pharmaceuticals for approximately $1.4 billion.

DUBLIN — Mallinckrodt, a specialty pharmaceuticals company, announced the completion of its acquisition of Cadence Pharmaceuticals for approximately $1.4 billion.

March 19, 2014

The Electronic Retailing Self-Regulation Program recommended Progenum International modify or discontinue certain claims for Zvelt, its weight-loss patch.

NEW YORK — The Electronic Retailing Self-Regulation Program on Tuesday recommended Progenum International modify or discontinue certain claims for Zvelt, its weight-loss patch.

March 19, 2014

The Electronic Retailing Self-Regulation Program on Tuesday announced it will refer direct response advertising for Dinamo to the Federal Trade Commission and the Food and Drug Administration after the marketer, Natures Flava, failed to respond to an ERSP inquiry.

NEW YORK — The Electronic Retailing Self-Regulation Program on Tuesday announced it will refer direct response advertising for Dinamo to the Federal Trade Commission and the Food and Drug Administration after the marketer, Natures Flava, failed to respond to an ERSP inquiry.

March 19, 2014

Ferring Pharmaceuticals announced that it received approval from the Food and Drug Administration for new labeling of its fertility products Menopur and Bravelle.

PARSIPPANY, N.J. — Ferring Pharmaceuticals announced that it received approval from the Food and Drug Administration for new labeling of its fertility products Menopur and Bravelle. The update is a result of the Combine trial, which showed that both Menopur and Bravelle can be safely mixed and administered in a single injection.

March 18, 2014

Avella Specialty Pharmacy announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act.

PHOENIX — Avella Specialty Pharmacy on Tuesday announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act. Outsource facilities must consent to greater federal oversight including more frequent inspections and are required to demonstrate their adherence to specific “good manufacturing practices,” Avella noted. 

March 18, 2014

The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning.

AMELIA ISLAND, Fla. — The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning. 

March 17, 2014

Abbott voluntarily recalled the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter, neither of which have been in production since 2010.

ALAMEDA, Calif. — Abbott on Friday voluntarily recalled the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter, neither of which have been in production since 2010. Other Abbott Diabetes Care meters are not affected by the recall. 

When used with the Abbott FreeStyle test strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter may produce mistakenly low blood glucose results. Abbott began notifying users on Feb. 19, 2014, immediately after the issue was discovered.

March 17, 2014

New York Attorney General Eric Schneiderman on Monday joined Ohio Attorney General Mike DeWine in leading an effort to persuade the largest pharmacy chains in the United States to stop selling tobacco products.

NEW YORK — New York Attorney General Eric Schneiderman on Monday joined Ohio Attorney General Mike DeWine in leading an effort to persuade the largest pharmacy chains in the United States to stop selling tobacco products. Along with Schneiderman and DeWine, the Attorneys General of 28 states and territories have written to the CEOs of WalMart, Walgreens, Rite Aid, Safeway and Kroger, asking them to remove all tobacco products from their shelves. 

March 17, 2014

An educational briefing, “Widespread Nutrient Shortfalls: A Public Health Crisis?” was held for Capitol Hill staffers Friday by the Congressional Dietary Supplement Caucus, in cooperation with the leading trade associations representing the dietary supplement industry — the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.

WASHINGTON — An educational briefing, “Widespread Nutrient Shortfalls: A Public Health Crisis?” was held for Capitol Hill staffers Friday by the Congressional Dietary Supplement Caucus, in cooperation with the leading trade associations representing the dietary supplement industry — the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.  

March 17, 2014

The legislature is mulling a bill that would alter the structure of Florida’s Board of Pharmacy, raising from one to three the number of seats for pharmacists representing both smaller and larger pharmacies, according to the Associated Press.

TALLAHASSEE, Fla. — The legislature is mulling a bill that would alter the structure of Florida’s Board of Pharmacy, raising from one to three the number of seats for pharmacists representing both smaller and larger pharmacies, according to the Associated Press.

The measure, proposed by Sen. Denise Grimsley, would also reduce from five to one the number of at-large posts for those with pharmacy licenses, the report states.

March 14, 2014

In a statement, HDMA president and CEO John Gray said the national association representing primary healthcare distributors applauds U.S. Attorney General Eric Holder's weekly address concerning the nation's prescription drug abuse epidemic.

ARLINGTON, Va. — In a statement, HDMA president and CEO John Gray said the national association representing primary healthcare distributors applauds U.S. Attorney General Eric Holder’s weekly address concerning the nation’s prescription drug abuse epidemic.

March 14, 2014

Legislation introduced to unclog the backlog of sunscreen ingredients and streamline the review process for faster public access has garnered the accolades of the Public Access to SunScreen Coalition.

WASHINGTON — Legislation introduced to unclog the backlog of sunscreen ingredients and streamline the review process for faster public access has garnered the accolades of the Public Access to SunScreen Coalition.

March 14, 2014

The Federal Trade Commission is holding a public workshop in March to examine U.S. healthcare competition issues as healthcare spending swallows up a significant part of federal and state budgets. Among the topics up for discussion, according to reports, are retail clinics and telemedicine.

WASHINGTON — The Federal Trade Commission is holding a public workshop in March to examine U.S. healthcare competition issues as healthcare spending swallows up a significant part of federal and state budgets. Among the topics up for discussion, according to reports, are retail clinics and telemedicine.

According to reports, the two-day workshop will be held March 20 and 21 in Washington, D.C. and will be webcast on the FTC’s site.

March 13, 2014

The American Association of Nurse Practitioners, a national professional membership organization for nurse practitioners of all specialties, is calling on state lawmakers to consider the consequences of undue restrictions on APRNs, or nurse practitioners, as recommended by the Federal Trade Commission.

AUSTIN, Texas — The American Association of Nurse Practitioners, a national professional membership organization for nurse practitioners of all specialties, is calling on state lawmakers to consider the consequences of undue restrictions on APRNs, or nurse practitioners, as recommended by the Federal Trade Commission.

March 12, 2014

Citing pharmacist-administered medication therapy management, recognition of pharmacists as healthcare providers, the need for fair and accurate pharmacy reimbursement in state Medicaid programs and other pharmacy services, the National Association of Chain Drug Stores has sent a statement to lawmakers urging them to consider pharmacy provisions within the “Fiscal 2015 Budget,” released by the administration last week.

ARLINGTON, Va. – Citing pharmacist-administered medication therapy management, recognition of pharmacists as healthcare providers, the need for fair and accurate pharmacy reimbursement in state Medicaid programs and other pharmacy services, the National Association of Chain Drug Stores has sent a statement to lawmakers urging them to consider pharmacy provisions within the “Fiscal 2015 Budget,” released by the administration last week.

March 12, 2014

Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

WASHINGTON, D.C. — Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.