HEALTH

PharmaSmart’s president, SVP join pharmacy school’s advisory council

BY Alaric DeArment

ROCHESTER, N.Y. Two executives from blood pressure screening equipment manufacturer PharmaSmart International have joined the Wegmans School of Pharmacy’s advisory council, PharmaSmart said Wednesday.

President Fred Sarkis and SVP and general manager Ashton Maaraba will work with the council to help plan and initiate new academic and extracurricular opportunities for the school and began their term by donating blood pressure screening equipment and Web services to the school for students to use in their studies.

“Ashton and I are very excited to become part of this prestigious committee, and we hope that our grant and continuing support make a difference for the students, faculty and the School of Pharmacy,” Sarkis said.

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FDA approves revised safety label for Xenical

BY Michael Johnsen

BETHESDA, Md. The Food and Drug Administration on Wednesday notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of the medication.

The agency also is adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for GlaxoSmithKline’s Alli.

Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription.

This new safety information, originally announced in August 2009, is based on FDA’s completed review of orlistat.

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Dietary supplement legislation receives support from CRN, NPA

BY Michael Johnsen

WASHINGTON Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, on Tuesday introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010, a piece of legislation designed to provide the Food and Drug Administration with additional enforcement resources.

Each of the leading trade associations representing the supplement industry issued their support behind the bill.

“[The Council for Responsible Nutrition] applauds Sens. Tom Harkin and Orrin Hatch for their efforts to fully fund, implement and enforce the Dietary Supplement Health and Education Act of 1994,” stated Steve Mister, CRN president and CEO. “CRN and its member companies have long advocated for more resources to help the FDA better enforce industry regulation, and this bill is a step in the right direction to making that happen.”

John Gay, executive director and CEO of the Natural Products Association added, “While some have called for additional regulations on supplements, Sens. Harkin and Hatch understand that the real need is to fully enforce the stringent statutes already on the books, to the full extent of the law. The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple.”

This legislation reinforces the authority FDA has to regulate the supplement industry under DSHEA, and ensures the agency has additional resources to more fully implement that authority. The bill would provide FDA with additional resources over a five-year period to accomplish important regulatory mandates set out by DSHEA, including:

  • Assuring that manufacturing facilities are GMP compliant through additional facility inspections;
  • Calling on FDA to issue clear guidance for new dietary ingredients and the submission of these NDI notifications, as well as the criteria for establishing a reasonable expectation of safety for these ingredients;
  • Implementing an annual registration process for supplement manufacturers, packers and distributors;
  • Requiring more dialogue between FDA and the Drug Enforcement Administration so that anabolic steroids or their analogues do not reach consumers as a mislabeled supplement; and
  • Developing appropriate consumer education initiatives that will create more informed supplement customers.

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