Managed Healthcare Executive - April 2009 - (Page 6) NEWS ANALYSIS Giving it away Feds map strategies to hand out billions from stimulus bill JILL WECHSLER WASHINGTON BUREAU CHIEF WASHINGTON, D.C. — There’s a feeding frenzy going on in Washington as federal agencies begin doling out the billions provided in the February economic stimulus package, or American Recovery and Reinvestment Act (ARRA). Tech companies are rushing from one brie ng on health IT to another, trying to assess opportunities to capitalize on the $19 billion available to develop a national electronic medical records system. Biomedical research organizations are lining up for some of the $10.4 billion provided to the National Institutes of Health. The Department of Energy’s O ce of Science and the National Science Foundation also are looking for ways to hand out funds e ectively. There’s $2 billion available to support construction projects expanding community health centers, plus additional funds to train more primary care physicians and health care workers. And everyone wants to get in on the comparative-e ectiveness research program. Government agencies are under orders to dole out the money quickly and wisely in order to create new jobs and spur economic recovery. As a result, NIH plans to distribute most of the $8 billion available for research grants to “shovel-ready” projects—i.e., applications that came in last year and were vetted by peer review boards but didn’t make the nal cut. In addition, NIH’s National Center for Research Resources is administering some $1.6 billion in grants for construction and repair of outside research facilities and for the purchase of equipment, including new computers and IT systems. Organizations seeking to tap into stimulus funds will require persistence and patience, though. Peter Orszag of the O ce of Management and Budget, reported last month that its Web site, grants.gov, was so overloaded with hopeful applicants that it was likely to crash. MHE Imagezoo/Getty Images Diabetes drug delays stir controversy Patient advocates oppose added FDA testing requirements JILL WECHSLER WASHINGTON BUREAU CHIEF WASHINGTON, D.C. — The Food and Drug Administration’s requirement for more safety information on new diabetes treatments might start claiming victims among the sponsors. In addition to showing that a new type 2 diabetes drug lowers blood sugar, FDA guidance issued last December directs sponsors to study whether drugs also raise the risk of heart attacks and strokes. Patient advocates and researchers are up in arms over this much higher hurdle 6 APRIL 2009 for the more than 100 diabetes drugs under development. The new preapproval safety data demand will mean millions of dollars and more years for development, says Diabetes Close Up publisher Kelly Close. Those sponsors who had completed trials and led NDAs (new drug applications) before the guidance was nalized are in a bind. FDA recently indicated that it may not approve Takeda Pharmaceuticals’ application for alogliptin, which was led months ago, because of insu cient clinical data on cardiovascular risk. Other new diabetes treatments from Bristol-Myers Squibb and Novo Nordisk made it to the advisory committee review stage earlier this month, but additional pre- and post-market testing may be needed. FDA justi es its new policy by the higher risk of heart disease among diabetics. It’s also a response to the safety crisis ignited by GlaxoSmithKline’s Avandia. Pharmaceutical companies generally are sucking it up and agreeing to meet FDA’s requirements to gain approval. Diabetes is a huge market, generating $23 billion in global drug sales. At the Diabetes Forum sponsored by Avalere Health in March, Robert Heine, head of diabetes drug development at Eli Lilly, acknowledged that the FDA guidance may double the cost of development programs. The future, he said, lies in moving beyond glucose-lowering to products that can control the natural course of disease and better manage cardiovascular risk. But Close and others consider FDA’s regulatory environment too stringent for drugs that don’t show any cardiovascular signals, and fear that manufacturers will be more likely to cancel development programs for drugs with any signs of cardiovascular events. We need “the right balance” at FDA between assuring safety and promoting innovation, Close commented. MHE http://www.grants.gov
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