Regulatory and Washington

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.

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.

Rather than take off for the holidays, the editors of Drug Store News took a look at the year ahead and the trends, issues and headlines that will makes the news in 2013.

What do you think? Follow us on Twitter and LinkedIn, and join the discussion there, or post your comments on DrugStoreNews.com ... Or, you can pretend it’s still 1999 and email your comments to [email protected]. Just don’t fax us.

NEW YORK — Despite caution among consumers, retailers wrapped up 2012 with a healthy holiday shopping season, according to a new report by a retailing trade group.

The National Retail Federation said Tuesday that holiday retail sales increased 3% over the year before, to $579.8 billion. December retail sales increased 0.8% seasonally adjusted from November and 2.1% unadjusted year over year. Nevertheless, the 3% increase was still below the NRF's projected 4.1% growth. Meanwhile, nonstore holiday sales grew 11.1%.

The nation’s highest court has agreed to hear three cases stemming from the longstanding but controversial practice by which branded and generic drug makers agree to delay introduction of a me-too medicine as its brand-name counterpart nears the end of its patent protection. A ruling by the Supreme Court could alter the delicate balance sometimes struck between the two industries as they scramble to either delay or hasten the onset of generic competition for big-selling, patented drugs.

WASHINGTON — The Generic Pharmaceutical Association has appointed a new officer to head its communications, the industry trade group said Tuesday.

The GPhA announced the appointment of Claire Sheahan as VP communications, effective Jan. 22. Sheahan previously worked as SVP and partner of communications firm Fleishman-Hillard, leading the firm's Washington-based healthcare practice.

NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.

WASHINGTON — The Department of Health and Human Services is proposing a new rule that it said would promote consistent policies and processes for eligibility notices in Medicaid, the Children's Health Insurance Program and the health insurance exchanges mandated under the Patient Protection and Affordable Care Act.