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Senators propose legislation to carve out ‘compounding manufacturers’ subject to FDA regulation

BY Alaric DeArment

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

New draft legislation — proposed in the Senate Health, Education, Labor and Pensions Committee by Sens. Tom Harkin, D-Iowa, and Lamar Alexander, R-Tenn., and others — would seek to resolve the issue by creating a new category of drug compounders called "compounding manufacturers" that would be subject to Food and Drug Administration regulation.

In the wake of the NECC scandal, FDA commissioner Margaret Hamburg called for giving the FDA the authority to regulate sterile compounding — compounding of medications, usually for injection, that differs from traditional compounding in its complexity and need for attention to sterile practices. Currently, compounding pharmacies are regulated by state boards of pharmacy.

The new legislation would require compounding manufacturers to register with the FDA and pay a fee intended to help cover inspections.

Trade group the National Association of Chain Drug Stores cautioned on what it called potential unintended consequences of the draft legislation, saying it was important to distinguish between traditional compounding – medication orders based on individual prescriptions for products not commercially available – and manufacturing.

“NACDS supports the mission and work of FDA in ensuring that Americans receive only safe and effective prescription medications. Safeguarding the health and welfare of our patients remains our highest priority,” the group said in a statement. “Pharmacist compounding services are the only source of critical medications for millions of patients who each have their own unique health care needs. For these patients, there are no commercially-manufactured preparations available. Accordingly, we agree with FDA that pharmacist compounding services are a valuable and important part of our nation’s healthcare system.”


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Esri mapping platform to aid Hy-Vee’s location decisions

BY Alaric DeArment

REDLANDS, Calif. — Midwestern supermarket chain Hy-Vee is expanding its use of a mapping platform made by geographic information systems firm Esri to aid its real estate decision-making, Esri said Wednesday.

Esri said this would allow Hy-Vee to enhance its site selection, using location analytics that combine demographic and psychographic data.

"We are able to combine data and improve analysis to get a much clearer understanding of new and existing markets," Hy-Vee SVP store development Andy McCann said. "We know how geography plans a significant role in consumers’ choices and behaviors. Using location analytics, we can maximize the way we respond to and understand our customers, stores and market presence."

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Merck submits FDA filing for ragweed allergy drug

BY Alaric DeArment

WHITEHOUSE STATION, N.J. — Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

Merck said the Food and Drug Administration accepted a regulatory application for its ragweed pollen sublingual allergy immunotherapy tablet. Ragweed, also known as Ambrosia artemisiifolia, is a major cause of seasonal allergies in the United States. Merck also submitted an application for a similar drug, for Timothy grass pollen allergies, in March.

The company expects the FDA to complete its review of both applications in the first half of next year. The drugs work by dissolving under the tongue and treating the underlying cause of allergic rhinitis by generating an immune response.

 

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