PHARMACY

Sen. asks CDER for pharmaceutical accountability options

BY Drew Buono

WASHINGTON Sen. Sherrod Brown, D-Ohio, is asking Center for Drug Evaluation and Research Director Janet Woodcock for the best ways to hold pharmaceutical companies accountable for contaminated drugs when they outsource production of ingredients to other countries.

“It is no coincidence that drug ingredients produced in countries with weak safety standards are often contaminated,” said Brown in a statement. “The FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe.”

Brown asks Woodcock in a June 12 letter to expand on her late-April testimony at a Senate Health, Labor, Education and Pensions Committee hearing in which she said the industry needs to be held accountable for the quality of drugs it markets. 

The hearing was held to discuss the heparin contamination. The contamination has been linked to numerous serious adverse events, including deaths. Brown also requests an estimate of the additional incremental costs to protect the public from “tainted pharmaceutical ingredients produced in countries without drug safety regimes comparable to those in the U.S.” Additionally, he wants an estimate of the volume of drug ingredients outsourced by U.S. firms to Chinese manufacturers, as well as producers in other countries with weaker regulations.

In the letter, Brown says addressing outsourcing trends needs to be considered as an emerging challenge for the FDA. “The drug industry is dealing our nation multiple blows by outsourcing drug ingredients; it is compromising U.S. drug safety and undermining U.S. jobs. Despite paying a steep price for pharmaceutical outsourcing, our nation still pays the highest prices in the world for prescription drugs. There is no evidence that outsourcing is translating into any savings for patients in the U.S,” he writes.

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Mass. approves $1 billion for state life sciences industry

BY Drew Buono

BOSTON The Massachusetts Senate has approved a $1 billion dollar bill designed to help development in the state’s life sciences industry, according to the Boston Globe.

The House passed the bill on Wednesday, which was followed by the Senate’s 31 to 7 vote in favor of approving the bill, a central piece of Governor Deval Patrick’s agenda.

The governor expects to sign the bill Monday, said his spokeswoman, Becky Deusser. Lawmakers are hoping to trumpet the legislation at an international biotechnology conference next week in San Diego.

Proponents of the bill said in Senate debate that the bill would boost the state’s economy while developing life-saving treatments. “This isn’t just for one industry. This will have an enormous impact over a longer run,” said Senator Harriette Chandler, a Worcester Democrat. She said the bill would also have an “absolutely revolutionary” impact on healthcare.

Senate minority leader Richard Tisei told members that the bill was an example of “pork barrel spending. …I just remind you that it’s the taxpayers that are paying. … It’s taxpayers’ money, it doesn’t grow on trees.”

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nFinanSe raises $10.7 million in securities sale

BY Drew Buono

TAMPA, Fla. The prepaid and gift card company nFinanSe has raised $10.7 million through the issuance of almost 1.5 million share of its common stock, about 4 million shares of its Series C Convertible Preferred stock and warrants to purchase over 2.6 million shares of its common stock.

Each share of the Series C Convertible Preferred Stock is convertible into one share of the company’s common stock. Both the Series C Convertible Preferred Stock and the common stock were sold at the purchase price of $2.00 per share. The warrants entitle holders to purchase shares of common stock at an exercise price of $2.30 per share.

In addition, the nFinanSe has closed on its previously announced $15.5 million accounts receivable line of credit with certain institutional investors and shareholders of the company, including Ballyshannon Partners, an affiliate of one of its directors. This line of credit will be used solely to support the company’s reloadable prepaid and gift cards at retail store locations.

Jerry Welch, chairman and chief executive officer, said, “The prepaid card industry is a rapidly growing and very dynamic sector of the U.S. economy. This financing, which will provide the company with over $26 million of capital, enhances our financial condition, strengthens our balance sheet and helps position us to aggressively pursue market share in the prepaid card marketplace.”

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