Report shows FDA slow in generics application reviews
WASHINGTON According to a report by the Department of Health and Human Services’ inspector general Daniel Levinson, the Food and Drug Administration failed to review nearly half the applications from generic drug manufacturers on time, as reported by Reuters.
The report also found that the agency approved or tentatively approved just 4 percent of generic applications reviewed in 2006, rejecting the majority because they did not meet the FDA’s standards.
The inspector’s office looked at the FDA’s review times in 2006 for 989 generic drug applications and found that 46 percent of them were not fully evaluated within the 180-day period allowed by law. Among a sample of 105 delayed applications, the agency did not even begin to review 70 percent of them until after the 180-day period had ended, the report found.
Part of the problem, the inspector said, is the way FDA officials prioritize applications. The agency reviews them on a “first-in, first-reviewed” policy rather than first tackling clear-cut applications that are not bogged down with patents or exclusivity issues that complicate the process. It takes the FDA a median time of nearly 17 months to approve generic applications, according to the report.
The FDA, in comments submitted to Levinson, said the agency was already implementing some of the report’s recommendations to improve its review process. It also said it was working with the industry to have drug makers submit more easily reviewed applications.
Mass. approves $1 billion for state life sciences industry
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.”
nFinanSe raises $10.7 million in securities sale
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.”