Reports: Senators introduce bill to ban ‘pay-for-delay’ settlements
NEW YORK — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.
Reuters reported that Sens. Amy Klobuchar, D-Minn., and Chuck Grassley, R-Iowa, were sponsoring a bill to ban so-called "pay for delay" settlements. Critics of such settlements say they delay patients’ access to cheaper generic drugs, while drug makers say the settlements are often necessary to allow launch of generics ahead of branded drugs’ loss of patent protection, and that delaying generic launch beyond patent expiry would be illegal anyway.
When a generic drug company wishes to challenge a branded drug’s patent, it will usually file a regulatory approval application with the Food and Drug Administration containing a paragraph IV certification, a legal assertion that the drug’s patent is invalid, unenforceable or not at risk of infringement. In response, the branded drug company will generally sue the generic company. The companies may then settle the case before the court and make a deal that allows the generic company to launch ahead of patent expiration but requires it to wait for a period of time. While the "pay" part of the "pay-for-delay" deal may include a cash payment to the generic drug maker, it most often involves an agreement by the branded drug company not to launch a so-called authorized generic — essentially the branded drug marketed under its generic name at a reduced price — during the legally mandated 180 days following FDA approval in which the generic product can compete exclusively with its branded counterpart.
Branded and generic drug makers alike have strongly opposed attempts to ban the patent settlements, saying that requiring cases to go to trial will only further delay the availability of generics. Industry opposition has contributed to the defeat of previous bills to ban them, Reuters noted.
FDA approves Elite Pharmaceuticals’ opioid painkiller
NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.
Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.
The drug is a generic version of Duramed’s Revia. The branded drug and generic versions had sales of about $16 million in 2012, according to IMS Health.
McKesson, Safecor Health partnership generating cost savings, efficiencies for alternate site pharmacies
SAN FRANCISCO — Alternate site pharmacies, including those serving long-term care and correctional care facilities, are realizing significant cost savings and greater efficiencies as a result of an innovative partnership forged by McKesson and Safecor Health, the San Francisco wholesaler announced Monday. According to McKesson, the year-over-year benefit can be as high as 15.5%.
"Alternate site pharmacies manage a great deal of complexity and associated cost in serving their customers, including operational inefficiencies, regulatory mandates, safety concerns and more," stated Rich McKeon, VP McKesson Alternate Site Pharmacy. "The McKesson/Safecor Health Partnership helps to alleviate the cost and complexity burden; it addresses evolving packaging needs based on the pharmacy’s business model, without upfront capital investments or extra staff."
The McKesson/Safecor Health Partnership combines McKesson’s distribution services with Safecor Health’s FDA-registered drug repackaging and barcoding services to deliver customized medication packaging solutions with low pricing to alternate site pharmacies.
The McKesson/Safecor Health Partnership also addresses medication packaging needs for alternate site pharmacies preparing to implement CMS-mandated changes for short-cycle dispensing, which became effective Jan. 1.
McKesson and Safecor Health estimated that a long-term care pharmacy serving 2,000 beds can realize a more than $57,000 annual cost benefit — a 15.5% improvement year over year — as a result of implementing the McKesson/Safecor Health third-party repackaging solution.
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