FDA advisory committees say Acurox approval lacks sufficient evidence
PALATINE, Ill. Two advisory committees of the Food and Drug Administration don’t have enough evidence to recommend approval of an opiate made by King Pharmaceuticals and Acura Pharmaceuticals designed to deter drug abusers, the two drug makers said Thursday.
King and Acura said the FDA’s Anesthetic and Life Support Drugs and Drug Safety and Risk Management committees would not recommend approval for Acurox (oxycodone hydrochloride and niacin). The niacin added to Acurox is meant to minimize the potential for oral abuse of the drug.
The FDA is not bound by advisory committee recommendations, but may take them into account when deciding whether to approve a drug.
Independence Blue Cross challenges business leaders to ‘Step Out’ and fight diabetes
PHILADELPHIA Independence Blue Cross is continuing its role as a presenting sponsor of Step Out: Walk to Fight Diabetes for the third consecutive year.
At a corporate kickoff breakfast held Wednesday, hosted with the American Diabetes Association, IBC president and CEO Joseph Frick — this year’s walk chair — urged business leaders to get involved in fundraising efforts for the upcoming annual walk on Oct. 2.
“At IBC, we’re committed to helping our members with diabetes live healthier lives and preventing the onset of this devastating disease among those who are at risk,” said Frick. “This is one of the many reasons we continue to make meaningful investments in prevention, wellness and health management programs for diabetes and other chronic conditions. Participating in Step Out is a great way to remind each other that our health should be a top priority. Equally important is our partnership with organizations like the ADA that are focused on diabetes prevention through education programs that reach our members and the community and help them understand the devastating effects of diabetes.”
Last year while Step Out walks took place in 166 other cities across the country, the Philadelphia walk broke national records as the largest in participation and fundraising. More than 3,500 people were in attendance and with the help of IBC and a number of local corporate and family-and-friend teams the ADA was able to raise more than $550,000.
“IBC’s presenting sponsorship of Step Out continues to demonstrate their care and concern for those in our community who suffer from diabetes and other chronic diseases,” said Russell Moore, ADA executive director of the southeastern Pennsylvania and southern New Jersey region. “Together we hope to communicate the importance of events like Step Out that bring people together in support of a good cause. Every year, each walker and every dollar raised brings us one step closer to a cure.”
Bill for fast response to drug abuse advances in Senate with NACDS nod
ALEXANDRIA, Va. A move by the Senate to root out early-stage drug abuse in the communities where it first takes hold gained a strong endorsement Thursday from the National Association of Chain Drug Stores.
NACDS president and CEO Steve Anderson sent a letter Thursday to Senate Judiciary Committee chairman Patrick J. Leahy, D-Vt., and Sen. Charles Grassley, R-Iowa, voicing the group’s support for legislation that would help stop drug abuse problems in the communities where they begin, before those problems move beyond the local level and impact a wider region. The new bill, which has bipartisan backing, targets abuse of both prescription and non-prescription medications and methamphetamine, among others.
“This bipartisan bill…builds upon the highly successful Drug Free Communities program by providing critical funding to local communities to more effectively deal with emerging drug trends and local drug crises,” wrote Anderson. “On behalf of our members, and the communities and families they serve, we are pleased to endorse your bill.”
Leahy and Grassley, who also serves on the Senate Judiciary Committee, introduced the bill as S. 3031, or the Drug Free Communities Enhancement Act of 2010. The legislation would authorize the director of the Office of National Drug Control Policy to fund community efforts that address emerging local drug issues or local drug crises.
Behind the proposal, according to language inserted in S. 3031, is “historical evidence showing that emerging local drug issues and crises can be stopped or mitigated before they spread to other areas, if they are identified quickly and addressed in a comprehensive multi-sector manner.”
The Senate Judiciary Committee approved the legislation on April 15, clearing its way for placement on the Senate legislative calendar. To reach President Obama’s desk for almost certain enactment, the bill would need to be passed in identical form by the Senate and House of Representatives.