Regulatory and Washington

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.

Recently, I had a brief conversation with a man I admire and respect very much, regarding the cover story of the Oct. 15 issue of DSN, “Building the ACO.”


“Eder, what’s an ACO?” the man asked.


I explained that it stands for accountable care organization; basically, it means providers from different practice settings working together to spread primary care responsibility across an integrated healthcare team. 


“You think that’s good?”


The Obama administration’s ambitious overhaul of the nation’s healthcare system weathered some significant challenges in 2012 and came through relatively unscathed.


The first major test came in June, when the U.S. Supreme Court refused to overturn the Patient Protection and Affordable Care Act, while still ruling that the law’s provision requiring individuals to obtain health insurance was unconstitutional.


What saved the ACA was the court’s decision that the government’s mandate to purchase health insurance qualified as a tax. 


NEW YORK — Kiosk manufacturer PharmaSmart got a visit from New York Gov. Andrew Cuomo Tuesday as he visited companies that his administration sees as leading the way in the state's economic development.

PharmaSmart was one of two companies in the Rochester, N.Y., area and one of 20 in the state overall to become part of Cuomo's Empire State Development Program.

Some legislators are concerned with the way energy drinks can affect young consumers, especially in light of news reports linking several deaths with energy drink use.

Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., are urging the Food and Drug Administration to move quickly to review the safety of these drinks.

WASHINGTON — The Food and Drug Administration will review the safety of energy drinks containing such stimulants as caffeine in response to a letter from two senators.