U.S. Marshals seize drugs from Caraco Pharmaceutical Labs
ROCKVILLE, Md. U.S. Marshals seized drugs made by generic manufacturer Caraco Pharmaceutical Labs Thursday at the company’s Michigian plants in Detroit, Farmington Hills and Wixom, at the request of the Food and Drug Administration.
The FDA said the seizure resulted from violations of the agency’s current Good Manufacturing Practice requirements by the company. Since January, Caraco has voluntarily recalled drugs due to potential manufacturing defects, including formulation errors and oversized tablets. The FDA found unresolved violations of cGMP requirements during an inspection of Caraco’s Detroit plant in May, the company said.
“The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements,” FDA associate commissioner for regulatory affairs Michael Chappell stated.
In a statement on the seizure, Caraco said it had taken corrective actions and was making “continual improvements,” noting that the seizure did not affect products made outside of Michigan.
PCMA launches ad campaign to push Senate on biosimilars
WASHINGTON An organization of the country’s pharmacy benefit managers has launched a new ad campaign to nudge senators on biosimilars.
The Pharmaceutical Care Management Association announced Thursday the launch of the campaign, directed at members of the U.S. Senate Health, Education, Labor and Pensions committee, hoping they will include “real” biosimilars legislation as part of healthcare reform.
The ad features a photo of a toddler and the caption “Meet the first recipient of an affordable biologic for hemophilia. He’ll be 66 years old when he finally gets it.”
“If this week’s report is accurate that Washington and the drug company lobby have reached some kind of new health reform ‘agreement,’ we sincerely hope that biogenerics is not part of it,” PCMA president and CEO Mark Merritt said in a statement. “The drug lobby will truly have reason to celebrate if Washington either ignores biogenerics reform or, worse, establishes a new process that could actually forbid competition for years after patents expire.”
Medical care for pre-diabetes costs nation $25 billion annually, new data shows
WASHINGTON One-in-4 American adults suffers from a silent condition known as pre-diabetes, a condition that costs the nation $25 billion a year in medical costs, according to new data.
Studies also show healthcare costs attributed with some 180,000 pregnant women diagnosed with gestational diabetes are estimated at $623 million a year.
In response to high diabetic healthcare costs, The American Diabetes Association recently engaged The Lewin Group to build upon a 2008 study that determined the estimated total direct and indirect costs of diagnosed diabetes in the United States to be $174 billion.
“It is absolutely critical that we understand the economic impact of diabetes on the nation so that we can develop health care policies that can effectively support the necessary behavior change and aggressive medical management needed to stem the diabetes epidemic,” said Dana Haza, senior director of NCDP, an initiative created by Novo Nordisk to drive systems change at the national and local level.
The studies, conducted by The Lewin Group, can be found in the current edition of the peer-reviewed journal Population Health Management.