Content about Regulatory and Washington

December 18, 2013

The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

December 18, 2013

The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.

December 18, 2013

Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

BALTIMORE — Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

Lupin's U.S. subsidiary launched its generic version of ViiV Healthcare's Trizivir (abacavir sulfate; lamivudine; zidovudine) tablets in the 300-mg/150-mg/300-mg strength. The launch follows a ruling by the U.S. District Court for the District of Delaware that the drug did not infringe on Viiv's patent.

December 18, 2013

The U.S. healthcare system saved $217 billion in 2012 thanks to the use of generic drugs, according to a new report by a generic drug industry trade group.

WASHINGTON — The U.S. healthcare system saved $217 billion in 2012 thanks to the use of generic drugs, according to a new report by a generic drug industry trade group.

December 17, 2013

In response to the study "Long-Term Multivitamin Supplementation and Cognitive Function in Men: The Physicians' Health Study II," and the editorial "Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements," published Monday in the Annals of Internal Medicine, the Council for Responsible Nutrition on Tuesday released two video statements.

WASHINGTON — In response to the study "Long-Term Multivitamin Supplementation and Cognitive Function in Men: The Physicians' Health Study II" and the editorial "Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements," published Monday in the Annals of Internal Medicine, the Council for Responsible Nutrition on Tuesday released two video statements.

December 17, 2013

Mylan and a partnering company will be able to sell a generic version of a cancer drug starting in summer 2015, under a court settlement announced Tuesday.

PITTSBURGH — Mylan and a partnering company will be able to sell a generic version of a cancer drug starting in summer 2015, under a court settlement announced Tuesday.

Mylan said that it and Banner Pharmacaps had reached a settlement agreement with Eisai and a subsidiary of Valeant Pharmaceuticals International to resolve a lawsuit filed over their generic version of Targretin (bexarotene) capsules in the 75-mg strength. The drug is used to treat certain forms of T-cell lymphoma.

December 16, 2013

The Food and Drug Administration may require makers of antibacterial soaps to perform clinical trials to show their products are better at preventing infections and disease than ordinary soaps.

SILVER SPRING, Md. — The Food and Drug Administration may require makers of antibacterial soaps to perform clinical trials to show their products are better at preventing infections and disease than ordinary soaps, part of a larger effort by the agency to ensure the safety and efficacy of antibacterial products and slow down the rise of antibiotic-resistant bacteria.

December 16, 2013

In support of the more than 1.1 million people living with HIV in the United States, Walgreens on Monday announced its collaboration with the Centers for Disease Control and Prevention to develop and evaluate a model of HIV patient-centered care through a national project aimed at advancing clinical integration and medication therapy management.

DEERFIELD, Ill. — In support of the more than 1.1 million people living with HIV in the United States, Walgreens on Monday announced its collaboration with the Centers for Disease Control and Prevention to develop and evaluate a model of HIV patient-centered care through a national project aimed at advancing clinical integration and medication therapy management. The program is another way Walgreens is extending its commitment to improve HIV prevention and treatment outcomes.

December 13, 2013

The Irish High Court has approved Perrigo's pending acquisition of Irish drug maker Elan, the companies said Friday.

ALLEGAN, Mich. — The Irish High Court has approved Perrigo's pending acquisition of Irish drug maker Elan, the companies said Friday.

December 13, 2013

The National Association of Chain Drug Stores underscored its commitment to improving the quality and affordability of the nation’s healthcare system and expressed concern about potential consequences of restricted pharmacy networks with the Patient Protection and Affordable Care Act exchange plans.

ARLINGTON, Va. — The National Association of Chain Drug Stores underscored its commitment to improving the quality and affordability of the nation’s healthcare system and expressed concern about potential consequences of restricted pharmacy networks with the Patient Protection and Affordable Care Act exchange plans in a statement to the U.S. House of Representatives Oversight and Government Reform Committee. 

The committee held a hearing Friday titled, “Premiums, Provider Networks and the Health Care Law.”


December 13, 2013

Pharmacy benefit manager Express Scripts hopes to drive down the cost of new drugs to treat hepatitis C by pitting their manufacturers against each other, according to published reports.

NEW YORK — Pharmacy benefit manager Express Scripts hopes to drive down the cost of new drugs to treat hepatitis C by pitting their manufacturers against each other, according to published reports.

Bloomberg News reported that ESI would pit companies like Gilead Sciences against others such as AbbVie when the new treatments become available in 2014 or 2015. The Food and Drug Administration announced last week the approval of Gilead's new drug, Sovaldi (sofosbuvir), which is designed to cut by three quarters the time needed for treatment.

December 12, 2013

The National Advertising Division referred advertising claims made by Bremmen Clinical, for its Vysera-CLS weight-loss supplement, to the Federal Trade Commission for further review.

NEW YORK — The National Advertising Division on Tuesday referred advertising claims made by Bremmen Clinical, for its Vysera-CLS weight-loss supplement, to the Federal Trade Commission for further review.

December 12, 2013

The National Community Pharmacists Association urged U.S. Senators on the Senate Finance Committee to support a proposal intended to expand coverage in the Medicare Part D prescription drug program of medication therapy management programs.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday urged U.S. Senators on the Senate Finance Committee to support a proposal — scheduled for a vote as soon as Thursday — intended to expand coverage in the Medicare Part D prescription drug program of medication therapy management programs.

December 12, 2013

Vitamin Shoppe announced that the company had filed suit against law firm Seeger Weiss in New York federal court.

NORTH BERGEN, N.J. — Vitamin Shoppe on Wednesday announced that the company had filed suit against law firm Seeger Weiss in New York federal court. Seeger Weiss has been using the company's name and trademark "Vitamin Shoppe" in its domain name and marketing materials, as well as the trademarked Bodytech name in marketing and soliciting materials without the company's permission, Vitamin Shoppe charged. 

December 11, 2013

While the Patient Protection and Affordable Care Act will undoubtedly reshape the U.S. healthcare industry for years to come, it is only one of many factors that will emerge next year, according to a new report.

NEW YORK — While the Patient Protection and Affordable Care Act will undoubtedly reshape the U.S. healthcare industry for years to come, it is only one of many factors that will emerge next year, according to a new report released Wednesday.

The report, Top Health Industry Issues for 2014, by PwC's Health Research Institute, was based on a survey of 1,000 consumers and interviews with health industry leaders.

December 11, 2013

The Food and Drug Administration is planning to limit the use of antimicrobials in food animals in an effort to stem the rise of antibiotic-resistant bacteria, the agency said Wednesday.

SILVER SPRING, Md. – The Food and Drug Administration is planning to limit the use of antimicrobials in food animals in an effort to stem the rise of antibiotic-resistant bacteria, the agency said Wednesday.

December 11, 2013

Reimbursement cuts to California's state Medicaid program are the subject of a lawsuit filed last week in San Francisco.

SACRAMENTO, Calif. — Reimbursement cuts to California's state Medicaid program are the subject of a lawsuit filed last week in San Francisco.

The Professional Pharmacy Alliance and the California Korean American Pharmacists Association filed suit against the California Department of Health Care Services in San Francisco Superior Court over an across-the-board 10% cut in 2011 to the reimbursement rates for most providers under the program, known as Medi-Cal.

December 11, 2013

All children attending day care or preschool in New York must get a flu vaccine by the end of the year, according to published reports.

NEW YORK — All children attending day care or preschool in New York must get a flu vaccine by the end of the year, according to published reports.

CBS News reported that the city's Board of Health voted unanimously Wednesday to require all children younger than 5 attending a day care or preschool to receive the vaccine before Dec. 31.

December 11, 2013

A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

DUBLIN — A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

Actavis said its Warner Chilcott subsidiary had settled with Zydus Pharmaceuticals USA and Cadila Healthcare over Zydus' generic version of Asacol HD (mesalamine) delayed-release tablets.

December 10, 2013

Lt. Gov. Ron Ramsey, Tennessee Rep. Tony Shipley, R-Kingsport along with representatives from Food City and the Consumer Healthcare Products Association, announced the expansion of Tennessee's statewide Anti-Smurfing Campaign.

KINGSPORT, Tenn. — Lt. Gov. Ron Ramsey, Tennessee Rep. Tony Shipley, R-Kingsport along with representatives from Food City and the Consumer Healthcare Products Association, on Monday announced the expansion of Tennessee's statewide Anti-Smurfing Campaign.  

December 9, 2013

The American Pharmacists Association's philanthropic wing has appointed five new members to its board of directors, the group said Monday.

WASHINGTON — The American Pharmacists Association's philanthropic wing has appointed five new members to its board of directors, the group said Monday.

The APhA Foundation announced in September the official installment of Stuart Haines, professor of and vice chairman for clinical services in the Unviersity of Maryland School of Pharmacy's Department of Pharmacy Practice and Science in Baltimore, as well as a clinical pharmacy specialist in primary care at the West Palm Beach, Fla., VA Medical Center.

December 9, 2013

Fifteen years after reaching more than $246 billion in legal settlements against the tobacco industry, most states have fallen short of spending a significant portion of the money on programs to prevent kids from smoking and help smokers quit, according to a report released Monday by a coalition of public health organizations.

WASHINGTON — Fifteen years after reaching more than $246 billion in legal settlements against the tobacco industry, most states have fallen short of spending a significant portion of the money on programs to prevent kids from smoking and help smokers quit, according to a report released Monday by a coalition of public health organizations.

December 9, 2013

Swiss drug maker Novartis is providing a vaccine to Princeton University amid an outbreak of potentially fatal meningitis that has affected at least eight students, the university said Monday.

CAMBRIDGE, Mass. — Swiss drug maker Novartis is providing a vaccine to Princeton University amid an outbreak of potentially fatal meningitis that has affected at least eight students, the university said Monday.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

WASHINGTON — The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

December 6, 2013

The Food and Drug Administration has approved a treatment for a sexual deformity that affects men.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for a sexual deformity that affects men.