Expert says FDA will be more vigilant in inspecting Chinese imports
WASHINGTON The Food and Drug Administration plans to be more watchful in inspecting overseas active pharmaceutical ingredient production facilities in the wake of the heparin contamination, according to a counterfeiting expert.
“As a whole, the FDA is going to be much more aggressive in inspecting and approving Chinese (drugs), particularly APIs, coming into the United States,” Donald deKieffer, a principal at the deKieffer & Horgan law firm, said. An expert on international counterfeiting and diversion, he said there are probably 30–40 counterfeiting rings operating in the U.S., some of which have substantial operations.
DeKieffer detailed a Florida counterfeiting ring led by Michael Carlow, who set up wholesale distribution companies, established relationships with wholesalers and sold them stolen medicines at discounted prices.
He then started buying medications in foreign countries at substantial discounts and shipping them to the U.S. for distribution. He used counterfeit pedigrees to authenticate the product, which he sold to wholesalers that then sold the drugs to other wholesalers. The counterfeit product ended up in warehouses of the big three distributors: McKesson, Cardinal Health and AmerisourceBergen.
DeKieffer said firms need to know their suppliers and customers. Checking to make sure customers are not in any databases of known diverters or counterfeiters is essential. “It’s always been astonishing to me that some very large and sophisticated manufacturers … continue to do business with known crooks … to whom they’re selling, both in this country and overseas. They’re selling lots and lots of product,” he said.
Pfizer invests in FivePrime for diabetes, cancer treatments
SAN FRANCISCO Pfizer has taken an equity investment in FivePrime Therapeutics as part of a new research and licensing deal to find antibody targets and therapeutic protein products to treat diabetes and cancer, according to published reports.
FivePrime, a preclinical stage company expected to file an investigational new drug application for its lead oncology compound within the next six weeks, will receive an upfront payment and the equity investment from Pfizer. It also will get three years of committed research funding.
The deal is one of the first by Pfizer’s new Biotherapeutics and Bioinnovation Center. The center is trying to boost the company’s pipeline by acquiring companies with promising drug developments.
Pfizer will have exclusive worldwide rights to develop and commercialize certain products and targets that are discovered, while FivePrime will receive future milestone and royalty payments.
The deal helps FivePrime take several of its potential cancer products into clinical trials while expanding its discovery work, said president and chief executive officer Gail Maderis.
The companies did not disclose figures for those aspects of the deal.
H-E-B, Kraft partner to offer health screenings
NEW YORK H-E-B, the Texas grocery chain, will offer health screenings at all its pharmacies on the second Saturday of every month until October.
The “Second Saturday Health and Wellness Screenings” program is sponsored by Kraft and offers free glucose and blood pressure screenings, as well as discounts on lipid panel, A1C and cholesterol screenings. Customers will receive free samples of healthy products as well.
Each screening has a theme: children for June, the military for July, the beginning of the school year for August, fitness for September and wellness for October.