Content about Pharmaceuticals policy

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November. 

WASHINGTON — The Community Anti-Drug Coalitions of America and the Consumer Healthcare Products Association on Tuesday joined forces to honor the Bucks County, Pa.-based Bucks Promise for Youth and Communities with this year’s Dose of Prevention award. This award recognizes community-based organizations that have implemented successful initiatives to raise awareness of the dangers of prescription drug abuse and OTC cough medicine abuse.

SPRINGFIELD, Ill. — H. D. Smith on Tuesday announced the establishment of H. D. Smith Specialty Solutions, an organization structured to provide focus and alignment around specialty and traditional brand products, solutions and services. The wholesaler also announced the realignment of select executive leadership positions to best capitalize on the growing needs resulting from recent geographic and service expansions. These expansions include the acquisition of Valley Wholesale Drug in October 2012 and a planned majority ownership investment in Triplefin announced in January 2013.

This will be a big year for implementation of the Patient Protection and Affordable Care Act, and the National Community Pharmacists Association will track the process closely on behalf of NCPA members and the patients they serve. NCPA recently submitted comments about the ACA’s Multi-State Plans, or MSPs, being designed by the Office of Personnel Management.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

The world market for generic drugs will jump more than 15% this year and reach a global total of $127.8 billion, a British market research firm predicted.

NEW YORK — The state supreme court in Alabama ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.

According to The New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer's acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis, now owned by Watson, make generic versions.

NEW YORK -- Growth in the consumer products market is likely to slow down over the next five years, while pharmacy retailers will see a profit windfall due to the generic drug cycle, according to a new report.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has hired a former executive from the Generic Pharmaceutical Association to head lobbying at the federal and state level, the company said Wednesday.

Watson announced the appointment of James Fenton as VP U.S. government affairs. In the new position, Fenton will work out of Watson's Washington offices and will be responsible for leading the company's expanded federal and state government affairs activities.

SAN FRANCISCO — While pressure to grow will drive more large drug makers to pursue mergers and acquisitions, diminished resources and competition from biotech and specialty pharmaceutical companies will challenge their ability to do so, according to a new report.

CINCINNATI, Ohio — Drug maker Prasco Labs has launched an authorized generic version of a drug used to treat heavy menstrual bleeding, the company said Monday.

Prasco announced the launch of tranexamic acid tablets in the 650 mg strength, an authorized generic version of Ferring Pharmaceuticals' Lysteda. Authorized generics are branded drugs marketed under their generic names at a discount, usually through third-party companies, to compete with Food and Drug Administration-approved generics.