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Senators urge congressional super committee to support ‘pay-for-delay’ ban

BY Alaric DeArment

WASHINGTON — Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

The Pharma Letter reported that Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, had urged the "super committee" to support a bill that would ban settlements that include any form of payment in exchange for holding off launch of a generic drug.

When a generic drug company wants to launch a product ahead of the expiration of the patent covering the branded version, it will file an application with the Food and Drug Administration containing a paragraph IV certification, an assertion that the patent is invalid, unenforceable or won’t be infringed. In response, the brand manufacturer will usually file a patent infringement suit, but many of these suits never go to trial and instead end in a settlement between the two companies.

In what the senators, the Federal Trade Commission and several advocacy groups have called "pay-for-delay" settlements, the generic drug company will agree to not immediately launch its product in exchange for a cash payment or, more often, a pledge by the brand company not to launch an authorized generic — essentially the branded drug marketed under its generic name for a lower price — during the 180 days of market exclusivity in which the generic and branded versions compete directly with one another. Nevertheless, in virtually all cases, generic launch takes place months and sometimes years ahead of patent expiration.

Critics say the deals delay generic launches for too long and thus cost consumers and the federal government billions of dollars, while brand and generic drug companies say the deals are often necessary to ensure the timely launch of a generic. At any rate, waiting until after patent expiration to launch would be against the law.


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Healthier snack options to augment move toward fresh

BY Michael Johnsen

MECHANICSBURG, Pa. — Worried you can’t get your child to eat their vegetables? Pack them in a chip. This Creative Snacks product pictured here was part of a Wegmans standee display just outside the pharmacy aisle and across the way from more natural chip selections (Terra Sweet Potato Chips, for example). These kinds of products may dovetail nicely with the drug channel’s move toward fresh — merchandising a healthier snack option in an easy-in, easy-out retail setting.

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WAG, Novo Nordisk, Sharps Compliance team up to offer free needle disposal system

BY Alaric DeArment

HOUSTON — Walgreens and Novo Nordisk are working with Sharps Compliance to offer Sharps’ Complete Needle Collection & Disposal System for customers who use injectable drugs.

Sharps said Monday that the program with the pharmacy retail company and drug maker would offer the system for free in a special promotional program that lasts from Oct. 23 until Nov. 19 and coincides with National Diabetes Month, with sponsorship from Novo Nordisk. The disposal system allows users of such injectables as insulin to safely dispose of used needles and ship them to Sharps, which then destroys them.

"Our unique three-way cooperative arrangement with Walgreens and Novo Nordisk is the first of its kind to involve a retail pharmacy and pharmaceutical manufacturer to address the proper handling and disposal of needles for the approximately 13.5 million people that require injectable medications for their health and well-being," Sharps president and CEO David Tusa said.

Under the program, which is receiving sponsorship from Novo Nordisk, customers at Walgreens can purchase the system at any Walgreens store and then receive a rebate form at the register for the $4.99 cost of the system.

"We believe that working together, we have an excellent opportunity to offer our customers a safe, environmentally friendly means of disposing of their needles, syringes or other injectable devices and are proud to offer the easy-to-use system for their safety and convenience," Walgreens group VP pharmacy operations Suzanne Hansen said.


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