Sen. Harkin poses questions for FDA following cough-cold medicine recall
WASHINGTON Sen. Tom Harkin, D-Iowa, on Monday penned a letter addressing Food and Drug Administration commissioner Margaret Hamburg following the recall of 40 varieties of children’s and infants’ formulations of Tylenol, Motrin, Zyrtec and Benadryl by Johnson & Johnson’s McNeil Consumer Healthcare.
“I commend you for FDA’s leadership in responding to this crisis, both in terms of your outreach to the public and your increased regulatory activity,” Harkin wrote. “However, I am interested in ensuring that, as a public health agency whose mission is to protect the American public, you have sufficient authority to prevent and respond to contamination of the drug supply. I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children.”
Harkin, who is chairman of the Senate health, education, labor and pensions committee that has jurisdiction over the FDA, posed questions regarding the recall, events leading up to it and consumer complaints.
Harkin was particularly interested in the voluntary recall process, asking if the FDA had initiated the request for a voluntary recall, and had they been denied that request, would the agency have had the authority to mandate a recall.
Harkin requested FDA respond to his list of questions by June 11.
Abbott receives regulatory approval for FreeStyle Lite test strips
ALAMEDA, Calif. The Food and Drug Administration approved blood-glucose test strips from Abbott.
Abbott’s new FreeStyle Lite test strips use an enzyme which is unaffected by common nonglucose sugars, such as maltose or galactose, and minimizes the potential for other interference, Abbott said. The strips also are compatible with the company’s FreeStyle Lite blood-glucose monitoring systems.
“The new FreeStyle Lite test strips represent Abbott’s latest success in delivering innovative products for people living with diabetes,” said Heather Mason, SVP Abbott Diabetes Care. “Abbott is delivering on what patients and healthcare professionals demand in diabetes care, especially for people who use insulin to manage their diabetes.”
FreeStyle Lite test strips will be available in July.
Bret Michaels raises $390K for American Diabetes Association
ALEXANDRIA, Va. The American Diabetes Association congratulated Bret Michaels on winning NBC’s “The Celebrity Apprentice” and raising $390,000 to further the association’s movement to stop diabetes.
Rock band Poison’s frontman — who has Type 1 diabetes — chose the American Diabetes Association as his charity during this season of “The Celebrity Apprentice.” The money that Michaels raised on the show will help support the American Diabetes Association, leading provider of diabetes camps.
“Nearly 24 million children and adults in the United States have diabetes and an additional 57 million are at risk,” said Larry Hausner, CEO, American Diabetes Association. “If current trends continue, one in three children will face a future with diabetes. We are proud of Bret’s win on the ‘The Celebrity Apprentice’ which will truly help the American Diabetes Association change the future of this disease.”