Possible new FDA diabetes drug guidelines could delay approvals
SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.
The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.
That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.
Von Eschenbach, Leavitt visit Dr. Reddy’s facility in India
HYDERABAD, India In January 2008 Food and Drug Administration Commissioner Andrew von Eschenbach and Secretary of Health and Human Services Michael Leavitt visited a Dr. Reddy’s facility near the pharmaceutical manufacturer’s headquarters here.
Leavitt was focused on assuring the quality of the products as well as creating collaborations beyond borders while von Eschenbach, also concerned with the safety and quality of products, focused on the transparency of the manufacturing process.
Dr. Reddy’s was the only facility in India the two visited as part of a multi-national effort to ensure the safety of the pharmaceutical supply chain.
Congressional report estimates CMS changes would cost states $50 billion in federal aid
WASHINGTON According to a congressional report prepared by the Democratic staff on the House Committee on Oversight and Government Reform, proposed changes to Medicaid would cost states about $50 billion in federal aid over the next five years, the Associated Press reported.
“As the economy tips into recession, the last thing we should be doing is taking federal funds from states, especially funds that are supposed to help people with their health and medical expenses,” said committee chairman, Rep. Henry Waxman, D-Calif.
Federal officials, though, are arguing that the changes are designed to ensure that providers don’t bill the program for more than costs of providing care and also say that the states pay their fare share of the program.
Tthe proposed new rules include limiting Medicaid public hostpital reimbursement to no more than the cost of providing a particular service. Another would prohibit billing Medicaid for the costs of medical interns and residents.
Overall, the federal government will spend more than $1.2 trillion on Medicaid over the next five years. The administration projects that if all the changes it seeks were enacted, the federal government would save about $13 billion over those five years.