GPhA announces conference talks will have emphasis on science, regulatory issues
ARLINGTON, Va. Scientific and regulatory issues for the generic drug industry will be the focus of the Generic Pharmaceutical Association’s two-day Fall Technical Conference, which starts Oct. 29.
The conference will include representatives from the generic drug industry and the Food and Drug Administration. Topics discussed will include the FDA;s Question-based Review Initiative, current good manufacturing practices, bioequivalence and the regulatory environment for generic drugs.
“Communication is a two-way street, and we look forward to this annual conference to foster increased dialogue to ensure the timely delivery of affordable, safe and effective generics to consumers,” GPhA president and chief executive Kathleen Jaeger said.
FDA approves Teva application for fentanyl patch
JERUSALEM The Food and Drug Administration has approved Teva’s application for its fentanyl transdermal system, the Israeli drug maker announced Monday.
The patches, which will deliver the medication at rates of 25 to 100 micrograms per hour for treating pain, are a generic equivalent to Johnson & Johnson’s Duragesic patches.
Combined sales of the branded and generic versions of the drug were $1.2 billion during the 12 months ending June 30, according to IMS Health data.
Teva said shipment of the patches had begun already.
Medicaid cost hikes ‘unsustainable,’ HHS secretary warns state budgeters
WASHINGTON Spending for Medicaid is rising to “unsustainable” levels, and the program’s rapidly rising costs are threatening access to health care for poor and lower-income Americans, Health & Human Services Secretary Mike Leavitt warned Friday.
The U.S. Centers for Medicare & Medicaid Services is projecting that the Medicaid program will spend $4.9 trillion over the next 10 years. That marks an average annual increase of 7.9 percent annually, according to federal budgeters, significantly outpacing the U.S. economy’s growth rate.
CMS released its report Friday, prompting a grim warning from the HHS secretary at a meeting of state budget directors. “This report should serve as an urgent reminder that the current path of Medicaid spending is unsustainable for both federal and state governments,” Leavitt said. “If nothing is done to rein in these costs, access to healthcare for the nation’s most vulnerable citizens could be threatened.”
Combined, Medicaid and Medicare are expected to gobble up 6.9 percent of the gross domestic product by 2017 at current growth rates, according to HHS. This year, Medicaid will see its rolls swell to a projected 50 million beneficiaries, at an average annual cost per person of more than $6,100.