Watson seeks approval for generic Type 2 diabetes drug
PARSIPPANY, N.J. — Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.
Watson said Thursday that it had filed with the Food and Drug Administration for approval of a generic version of Depomed’s Glumetza (metformin hydrochloride extended-release tablets) in the 1,000-mg strength.
In response, Depomed and a division of Valeant International filed suit against Watson Wednesday in the U.S. District Court for the District of Delaware, alleging that Watson’s application infringes two patents covering Glumetza. Under the Hatch-Waxman Act, the suit puts a stay of FDA approval on Watson’s drug for 30 months, or until Watson and the companies suing it settle the case.
GPhA signs on with IMS Health to address drug shortages
WASHINGTON — A trade organization representing generic drug manufacturers announced Thursday its latest solution to the problem of drug shortages.
The Generic Pharmaceutical Association announced a partnership with IMS Health, whereby IMS will serve as the independent third party in the Accelerated Recovery Initiative, a program the GPhA announced in December 2011 that is designed to use real-time supply and distribution information to help manufacturers, wholesalers, distributors, the Food and Drug Administration and group purchasing organizations understand current conditions and expand the supply of critical medications to patients who need them. At the time of the announcement of the ARI, the GPhA said it would involve an "independent third party," but didn’t specify which company that would be.
IMS, which provides data-mining and analysis services to drug manufacturers, will collect and process information from generic drug companies in order to identify where shortages are and where they are likely to develop, and then send the information to the FDA.
Manufacturers will provide funding for the project, with costs "somewhere in the several hundred-thousand range," GPhA president and CEO Ralph Neas said.
"As an established industry leader with decades of experience, IMS is ideally suited to fill this critical role," Neas said. "IMS commands the respect of all stakeholders and has a reputation for confidentiality. Their unique ability to collect, process and communicate the complex manufacturing data the ARI requires will be essential to the initiative’s success and will strengthen the entire healthcare industry’s collective ability to increase communication and supply patients with the medicines they need."
The Obama administration announced in October 2011 that it would seek to address the problem of drug shortages. As of that time, the FDA and the American Society of Health Systems Pharmacists found shortages of 168 drugs. According to IMS, while this represents a small and highly concentrated portion of the overall drug market, it includes a number of critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system disorders and pain, and more than 80% are injectables and generics.
Since then, the FDA has taken various actions to address shortages. In February, the agency sought to address shortages of the chemotherapy drug Doxil (doxorubicin hydrochloride liposome) by temporarily allowing India-based Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Labs, to import an identical drug, Lipodox, after a shortage of Doxil resulting from the closing of drug maker Ben Venue’s manufacturing plant in Bedford, Ohio.
The FDA also gave expedited review to APP Pharmaceuticals’ preservative-free methotrexate, used to treat leukemia in children and osteosarcoma, as well as autoimmune disorders, while Hospira released a month’s supply of 31,000 vials of the drug, and the agency said it would work with Mylan, Sandoz and other companies to increase production.
The GPhA also is hoping for passage of the Generic Drug User Fee Act, which will provide the FDA with $1.5 billion of additional funding and reduce the amount of time it takes to review generic drug and supplement applications by nearly two years.
Lawmakers to address 2012 NCPA Legislative Conference attendees
ALEXANDRIA, Va. — In anticipation of its 2012 Legislative Conference next month, the National Community Pharmacists Association unveiled its lineup of congressional speakers who will discuss pressing healthcare and pharmacy issues with pharmacists.
The current program for NCPA’s 2012 Legislative Conference, which will be held May 7 to 9 in Washington, D.C., includes Sens. Jerry Moran, R-Kan., and Sherrod Brown, D-Ohio, as well as Reps. Dave Camp, R-Mich.-4th; Frank Pallone, D-N.J.; Aaron Schock, R-Ill.; and Mike Ross, D-Ark.
"We commend these members of Congress for supporting patients’ access to independent community pharmacies and for their plans to speak during our Legislative Conference," NCPA CEO Douglas Hoey said. "Our members look forward to visiting them and talking face-to-face about how Medicaid cuts, MAC pricing, abusive audits, mandatory mail order, and other issues are hurting small business pharmacies and pharmacists’ ability to serve their patients."