FDA commissioner calls for international inspection offices
WASHINGTON Food and Drug Administration commissioner Andrew von Eschenbach spoke at the National Press Club on Friday, saying that the agency must increase risk-based inspections and collaborations with foreign partners as well as establish offices overseas.
The announcement comes as the FDA finds itself under fire for recent inspection mistakes made by the agency overseas. It was recently reported that the FDA mistakenly said it had inspected a plant in China that was manufacturing the blood thinner heparin. The FDA had actually taken the approved inspection from a previous inspection conducted, a practice the agency often uses.
In response, von Eschenbach has called for an initiative entitled FDA Without Borders, under which the agency will establish offices in at least five regions beginning in China. Other areas include India, the Middle East and Central and South America. The commissioner explained that the agency must work with foreign regulators to share information completely by saying, “This requires us to regulate products where they are produced,” he said. The FDA is also working on developing system called Predict, which will enhance the amount and kind of information the agency gathers, allowing it to better identify where to target resources.
The agency also plans on expanding its workforce to help with these new programs, about 700 more employees this year, according to von Eschenbach.
Rx program more expensive than chain store prescriptions
DENVER Rx Outreach, a Colorado program aimed at helping low-income people afford drugs for chronic diseases, was found to be more expensive for purchasing drugs than regular chain-store pharmacies.
A 90-day supply from a choice of 110 generics costs about $20 each, and three-dozen other drugs sell for $30 and $40. In contrast, Kmart’s program for a choice of 300 generic medications for a 90-day supply retails for $15, while Costco sells their prescriptions for about $10.66 and Walgreens sells them for about $12.99.
The program, Colorado Cares Rx, was unveiled this month by the Department of Health Care Policy and financing in partnership with Rx Outreach. The program was started by the state to develop a low-cost drug program, but the sponsors are finding it harder to compete with chain store rivals, based on pricing.
Officials claim growing pains, however. Rep. Alice Madden, D-Boulder, said “This is just a first step. We have to do more.”
FDA approves Abilify for teens
TOKYO and PRINCETON, N.J. The Food and Drug Administration has approved the Otsuka Pharmaceuticals and Bristol-Myers Squibb drug application for Abilify for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in pediatric patients aged 10 to 17.
The approval is based on the results of a four-week study that compared Abilify to a placebo in treating pediatric patients with bipolar disorder I. Otsuka Pharmaceuticals sponsored the study.
“We are pleased that the FDA has approved Abilify to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder,” said Taro Iwamoto, Ph.D., chief executive officer, president and chief operating officer, Otsuka Pharmaceutical development and c commercialization. “The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population.”