PHARMACY

Walgreens puts hold on its plan to sell genetic test kits in stores

BY Jim Frederick

DEERFIELD, Ill. Apparently having second thoughts on a deal that would have put genetic testing kits up for sale in its stores, Walgreens said Thursday it would delay any move to offer the products until questions posed by the Food and Drug Administration about the product are resolved.

Those questions arose following published reports that Pathway Genomics would begin selling its genetic test kits in most Walgreens stores this week. The reports triggered new scrutiny from the FDA, which indicated this week that it has no record of having approved the kits for sale.

The federal agency – which may be adopting a more assertive stance to product reviews and approvals under commissioner Margaret Hamburg – told Reuters news service that it would “take a hard look at any claims made by the company.”

Both Walgreens and Pathway asserted earlier this week that FDA approval is not needed for the sale of test kits in a retail setting. But FDA spokesperson Erica Jefferson told Reuters on Tuesday, “If a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do.”

In response, Walgreens reversed course. The company said Thursday has shelved, for now, its plan to go ahead with a rapid rollout of the kits.

“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” said Walgreens spokesman Jim Cohn.

The tests are saliva-based, and are intended to assess via DNA analysis patients’ genetic markers for such potential conditions as diabetes and cancer.

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Pfizer acquires rights to terguride

BY Alaric DeArment

NEW YORK Pfizer will acquire worldwide rights to a drug for treating pulmonary arterial hypertension, the drug maker said Wednesday.

Pfizer announced it would acquire terguride, an investigational drug, from Germany-based Ergonex Pharma. Under the agreement, Pfizer will support completion of phase 2 clinical trials of the drug and have exclusive worldwide rights to commercialize the drug, except in Japan. Ergonex will receive milestone and royalty payments.

“Pfizer’s unique business unit structure positions us to advance a broad portfolio of innovative research programs designed to lead to a diversity of products, including highly specialized ones in disease areas like PAH,” Pfizer specialty care business unit president Geno Germano said. “In the case of terguride, we are pleased that we can support its continued development given our commitment to advancing science in PAH and to bring new, potentially disease-modifying treatments to patients.”

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USP recommends prescription labeling be standardized

BY Alaric DeArment

ROCKVILLE, Md. An advisory panel of the U.S. Pharmacopeial Convention has recommended standardizing prescription labeling so patients can more easily understand the instructions, USP said.

USP, a nonprofit organization that sets standards for the identity, strength, quality and purity of medicines in the United States, cited Institute of Medicine statistics indicating that limited health literacy affects 90 million adults, thus reducing their ability to benefit from the healthcare system.

“Patients have the right to understand health information that is necessary to safely care for themselves and their families,” USP Health Literacy Prescription Container Labeling Advisory Panel co-chairwoman Joanne Schwartzberg said. “Confusing medication labels is one area that can be improved considerably. As most of us who have ever received a prescription drug know, the contact and appearance of medication labels can vary widely.”

Recommendations included simplifying language on labels by eliminating unfamiliar terms and unclear medical jargon, using explicit language to describe dosing and interval instructions and improving readability by using clearer fonts.

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