Content about Regulatory and Washington

WASHINGTON — President Barack Obama has proposed increasing federal taxes on cigarettes, drawing criticism from tobacco companies and praise from anti-smoking groups.

As part of his proposed budget, Obama proposed raising the tax on cigarettes by 94 cents per pack, with similar increases on other tobacco products. The current tax is $1.01 per pack.

TAMPA, Fla. — The National Association of Specialty Pharmacy has named James Smeeding its first executive director, the group said Tuesday. The announcement was made during its first Specialty Pharmacy Conference in San Diego, which drew more than 500 participants.

Smeeding is the founder of the University of Texas College of Pharmacy's Center for Pharmacoeconomic studies and has worked for a variety of companies and organizations, including the TPG National Payor Roundtable, the Jestarx Group, Digital Health Dialog and others.

NEW YORK — A desire to save money is driving younger and older adults to request cheaper drugs from their doctors, but it's also driving younger adults not to take their drugs as prescribed, according to a new study.

PARSIPPANY, N.J. — A growing number of patients on Medicaid are filling their prescriptions through Managed Medicaid plans instead of the fee-for-service model as states switch them over in an effort to improve patient care and cut healthcare costs, but the effects remain unclear, according to a new study.

NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma's behalf in extending patent exclusivity for Plan B One-Step. 

NEW YORK — The National Advertising Division on Friday recommended that Matrixx Initiatives discontinue advertising claims that suggest its homeopathic Zicam Cold Remedy products prevent users from catching a cold.

Claims at issue were featured in an advertising campaign that depicted a “Cold Monster” and encouraged treatment with Zicam products at the “pre-cold” stage.

HYDERABAD, India — Dr. Reddy's Labs has launched zoledronic acid injection in the 5 mg-per-100-mL strength, the Indian generic drug maker Thursday.

The drug, launched following its approval by the Food and Drug Administration, is a generic version of Novartis' Reclast and is used to treat osteoporosis. Reclast had sales of $355 million during the 12-month period that ended in February, according to IMS Health.

WASHINGTON — A committee of Florida's state Senate has passed a bill that could limit the use of biosimilars in the state.

The Florida Senate Committee on Health Policy passed S.B. 732, sending it to the full state senate. The legislation would require pharmacists to inform doctors when a follow-on biologic was substituted for a brand-name biotech drug. The bill is similar to one signed into law last month by Virginia Gov. Bob McDonnell.

PITTSBURGH — The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said Wednesday.

Mylan announced the approval of acyclovir ointment in the 5% strength. The drug is a generic version of Valeant International's Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems.

ALEXANDRIA, Va. — The recent call letter released by the Centers for Medicare and Medicaid Services addresses issues that can have an adverse effect on the program's cost and quality of care, a trade group representing independent retail pharmacies said Wednesday.

Commenting on the CMS' announcement, the National Community Pharmacists Association said it had prepared a detailed list for its members.

PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.