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Enact PDUFA, but leave restrictions out of it

BY Jim Frederick

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate’s version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

That amendment, from Sen. Joe Manchin, D-W.Va., was slipped in as the Senate hammered out its final version of the Safety Innovation Act. It has nothing to do with the reauthorization of user fees, which are paid each year by drug manufacturers to help the FDA allay the staffing and operational costs of reviewing the hundreds of new drug applications it receives each year.

Instead, Manchin decided PDUFA would serve as a handy legislative vessel in which he could insert new and unnecessary restrictions on the sale of pain remedies commonly available in any pharmacy.

The Manchin proposal would make it tougher for patients to obtain common pain relief remedies containing hydrocodone — and tougher by far for pharmacies to offer them. How? By raising those pain relief meds from Schedule III to the more-restrictive Schedule II classification.

The nation’s top community pharmacy advocates haven’t let the amendment go unchallenged. Five pharmacy groups — the American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists, National Association of Chain Drug Stores and National Community Pharmacists Association — sent a letter in late May to every U.S. member of Congress and senator, warning that the new classification would "result in significant barriers for patients who have a legitimate need for these products and result in adding to the nation’s health care costs with no assurance of a reduction in diversion and abuse."

The restrictions would also make it impossible for doctors to phone prescriptions into pharmacies for those pain relievers, or even to electronically prescribe them in some states. What’s more, if enacted, the shift to Schedule II would boost dispensing costs to pharmacies, noted the organizations, "including significantly higher administrative costs, due to recordkeeping, inventory management and storage requirements."

If you agree, join NACDS and other groups in opposing the Manchin amendment. If not, please share your reasons why with us.

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Save-A-Lot looking for college interns to ‘hit the road’

BY Michael Johnsen

ST. LOUIS — Save-A-Lot, a wholly owned subsidiary of Supervalu, on Monday launched a national search for a team of two interns to serve as brand ambassadors — or more aptly titled Road Scholars — for its 2012 Fuel Your Family Road Trip campaign.

The winning team will hit the road at the end of July for a four-week tour to 12 U.S. cities to personally bring the brand to consumers and help show people how Save-A-Lot can help families with savings of up to 40%, compared with traditional grocery stores.

Throughout the four-week road trip, the Road Scholars will attend community events, conduct random acts of kindness and sampling, host customer appreciation events at Save-A-Lot stores, and share tips for affordable, easy road trip snacks, and breakfast and lunch ideas.

As part of the national search for this year’s Road Scholars, teams of two are invited to submit their resumes, writing samples and a 90-second-or-less audition video explaining why they deserve this unique internship. Videos will be evaluated based on originality, creativity and poise, as well as applicants’ ability to create social media buzz for their videos. Candidates must be college graduates or enrolled in an accredited college and have strong communications, social media and interpersonal skills.

This year’s Fuel Your Family Road Trip route will include stops in Florida; Georgia; South Carolina; North Carolina; Virginia; Washington, D.C.; Maryland; and New York.

The experiential program was created to give consumers the opportunity to personally connect with the Save-A-Lot brand and raise awareness of Save-A-Lot as a destination.

In 2011, the road trip team of Abby Tinberg and Bob Ringer visited 10 U.S. cities.

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Barilla rolls out microwaveable meals

BY Allison Cerra

BANNOCKBURN, Ill. — A new line of shelf-stable microwaveable meals has arrived from Barilla.

The pasta brand has introduced five varieties of microwaveable meals, including mezze penne with traditional marinara sauce, mezze penne with tomato and basil Sauce, mezze penne with spicy marinara sauce, whole grain fusilli with vegetable marinara sauce and whole grain mezze penne with tomato and basil sauce. The meals are made with 100% natural ingredients and no preservatives and provide between 10 g and 11 g of protein.

Barilla microwaveable meals carry a suggested retail price of $3.29 per 9-oz. package and available in Albertsons, Giant Foods, Jewel-Osco, Kroger, Publix, Safeway, Stop & Shop, Target and Walmart.

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