Regulatory and Washington

WASHINGTON — The Consumer Healthcare Products Association on Friday released a statement regarding a poll released last week by the Asthma and Allergy Foundation of America. 

TOKYO — The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

Otsuka Pharmaceutical and H. Lundbeck announced the FDA approval of Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation indicated for the treatment of schizophrenia.

The companies described Abilify Maintena as the first dopamine D2 partial agonist approved as a once-monthly injection, contributing to a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia.

ARLINGTON, Va. — The National Association of Chain Drug Stores has launched a mobile app for its upcoming 2013 Annual Meeting in Palm Beach, Fla., the retail pharmacy trade group said.

Sponsored by the Emerson Group, the app is designed to provide attendees with an updated schedule, list of speakers, floor plan, list of companies and other important information. The meeting takes place from April 20-23.

WASHINGTON — The Pharmacy Technician Certification Board is making changes to its certification program that it said would advance pharmacy tech certifications, the group announced.

The PTCB said that over the next seven years, it would phase in the changes, which include mandatory background checks, accredited education requirements and changes in acceptable continuing education programs for recertification. The group said its requirements have remained largely unchanged since its 1995 founding.

WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.

ARLINGTON, Va. — Every year, the Centers for Medicare and Medicaid Services issues a "call letter" to lay out various policies and requirements for the coming program year within the Medicare program.

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday applauded the Kentucky Senate for voting to pass S.B. 107, a bill that will provide transparency regarding how pharmacy reimbursements are determined for multiple source generic drugs, and establish an appeals process when a dispute arises over those payment levels.