FDA approves Abilify Maintena for schizophrenia
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.
PTCB to change pharmacy tech-certification program
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.
"PTCB is elevating our certification requirements in order to meet the demands of the evolving healthcare system," PTCB executive director and CEO Everett McAllister said. "We have made bold decisions on what will be required for candidates to become certified pharmacy technicians. Our board of governors is sharply focused on ensuring that the PTCB program prepares CPhTs for the integral roles they play in supporting pharmacists in all practice settings."
New candidates will be required to complete criminal background checks starting in 2014, and individual CPhTs will have to complete one our of medication-safety continuing education in addition to the one hour of CE law already required. By 2015, the organization will require all 20 recertification CE hours to be pharmacy tech-specific, and the allowable CE hours from college courses will be reduced from 15 to 10 by 2016, while allowable in-service hours will be phased out by 2018.
By 2020, the PTCB will require candidates for initial certification to successfully complete an American Society of Health-System Pharmacists-accredited education program, which includes didactic coursework and practical experience, thereby providing well-rounded training for technicians.
Supreme Court to hear patent settlements case
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.
The FTC has long been an opponent of so-called “pay-for-delay” deals between brand and generic companies. When a generic company wishes to launch a generic version of a drug early, it will file a regulatory application with the Food and Drug Administration containing a Paragraph IV certification, an assertion that the branded drug’s patent protection is invalid, unenforceable or won’t be infringed. In virtually all cases, the branded drug’s manufacturer will sue the generic drug maker for patent infringement, but usually, the generic drug maker agrees to hold off launch in exchange for the branded drug maker agreeing not to launch an “authorized generic” — essentially the branded drug marketed under its generic name at a reduced price, usually through a third-party company — or, less commonly, monetary payment.
At any rate, supporters of the deals say, they typically result in generic drugs becoming available months or even years before patent expiry, and holding off launch of the generic after patent expiry would be illegal.
The Generic Drug Association on Friday filed an amicus brief with the court, saying that the deals benefit consumers. “We believe the court will find that patent settlements are pro-consumer, pro-competition and transparent,” GPhA president and CEO Ralph Neas said. “The proof is in the track record: When a patent settlement is reached, consumers gain access to the lower-cost generic medicines prior to patent expiration 100% of the time. These settlements have saved the healthcare system tens of billions of dollars over the past decade.”