GPhA urges congressional super committee not to ban patent settlements
WASHINGTON — The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.
The Generic Pharmaceutical Association took out an advertisement in the Wall Street Journal that quoted several figures — including Federal Trade Commission commissioner J. Thomas Rosch and Sens. Frank Lautenberg, D-N.J.; Tom Carper, D-Del.; Bob Casey, D-Pa.; Kay Hagan, D-N.C.; and former Sen. Arlen Specter, D-Pa. — voicing opposition to FTC chairman Jon Leibowitz’s efforts to ban the settlements.
"The facts are crystal clear — patent settlements save consumers and taxpayers billions of dollars," GPhA president and CEO Ralph Neas said. "The growing chorus of lawmakers urging the super committee to resist efforts to put a patent settlement ban into their recommendations offers further proof — such a ban is bad public policy that would have a detrimental impact on the American public and eliminate billions of dollars in healthcare savings from our country."
Neas also wrote a letter to Politico that criticized an op-ed on the site by Leibowitz and defended the settlements..
"Leibowitz would like readers to believe that these settlements harm consumers by driving up the price of prescription medicines," Neas wrote. "This is inaccurate. Indeed, settlements provide patients early access to lifesaving medicines months, and often years, before a drug’s patent would have otherwise expired — giving consumers a break from more expensive brand products."
Under the Hatch-Waxman Act of 1984, a generic drug company that wishes to launch its version of a branded drug after the latter’s market exclusivity period has expired but before its loss of patent protection, may file a regulatory approval application containing a paragraph IV certification, which asserts that the patent is invalid, unenforceable or that the generic won’t infringe it.
In most circumstances, the branded manufacturer will sue the generic manufacturer for patent infringement. But usually, both companies will reach a settlement of some sort. In some cases, the settlement involves the generic drug company agreeing not to immediately launch a product in exchange for a payment, which sometimes includes cash but usually means that the branded drug manufacturer agrees not to launch a so-called authorized generic — essentially the branded drug marketed under its generic name at a reduced price — during the 180-day period in which the first company to win approval for the generic gets to compete exclusively with the brand manufacturer before the drug becomes commoditized, and any company can market a generic version.
It’s these settlements that have the FTC and Leibowitz, as well as members of Congress, including Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, irked the most. The FTC said the deals cost consumers and taxpayers $3.5 billion per year because they result in delayed entry of cheaper generics into the market.
Click here to view the WSJ ad.
Actavis launches Kadian authorized generic
MORRISTOWN, N.J. — Actavis has launched an authorized generic drug for treating pain, the company said.
The drug maker announced Friday that it had started shipping morphine sulfate extended-release capsules, an authorized generic version of Kadian, which it also manufactures. The authorized generic product was launched on the same day as Watson Pharmaceuticals’ generic version.
Authorized generics are branded drugs marketed under their generic names at a reduced price, either by the branded drug’s manufacturer or a third-party company through a contractual agreement, as a way to provide the branded manufacturer an additional means of competing against the generic manufacturer during the latter’s legally mandated, 180-day market-exclusivity period.
Kadian had sales of $275 million during the 12-month period ended in September, according to IMS Health.
NACDS bolsters staff with new communications manager
ALEXANDRIA, Va. — The National Association of Chain Drug Stores has hired healthcare policy reporter Ben Moscovitch to serve as communications manager.
Moscovitch joins NACDS’ marketing, communications and media relations department, and will report to Chrissy Kopple, VP media relations. Prior to joining NACDS, Moscovitch served as the managing editor for Inside Washington Publishers’ FDA Week and wrote for the Inside Health Policy website. In this capacity, Moscovitch reported on issues that relate directly to pharmacy and to other aspects of healthcare delivery.
“Ben will bring additional expertise and professionalism to an NACDS team that dedicates its talent and tenacity to advancing community pharmacy every day,” stated NACDS president and CEO Steve Anderson. “At the heart of the NACDS brand is a commitment to talking externally and with passion about the work of the people of community pharmacy, and we look forward to the unique perspective that Ben will bring to this effort as a journalist and as a creative communicator.”
Previously, Moscovitch served as a reporter for Exchange Monitor Publications, and as a writer in the government affairs office of Underwriter Labs. He also has written articles for the Foreign Policy Association, focusing on Middle East issues.