MASSDEVICE ON CALL — A U.S. House of Representatives committee slammed the FDA over the $1 billion in unobligated user fees the watchdog agency is carrying on its books.
"While Congress did allow for some exemptions from fiscal year limitations and for some amounts to be carried forward into subsequent fiscal years, it could not have been anticipated that FDA would be carrying in excess of $1,000,000,000 in unobligated user fees halfway into any fiscal year," according to a report from the House Appropriations Committee. "In the tobacco user fee program alone, the fiscal year 2012 unobligated balance that carried over into fiscal year 2013 was $600,000,000. While FDA estimates this figure will drop to $250,000,000 by the end of fiscal year 2013, the committee remains skeptical that this will occur."
Manufacturers pay the user fees in return for reviews of their products; the most recent user fee authorization for medical devices called for the agency to meet timeliness benchmarks to reduce the backlog of FDA applications
The House panel wants the agency to categorize each fee and provide "a detailed explanation of what accounts for the balance and what the balance will be used for," according to the report.
Bipartisan group wants CMS to delay competitive bidding
The Centers for Medicare and Medicaid Service is under pressure from a bipartisan group of legislators in Washington to postpone competitive bidding for durable medical equipment. The group petition is concerned about unlicensed suppliers in the marketplace.
PwC calls sluggish healthcare growth rates "new normal"
Slow recession recovery and a lockdown of reimbursement rates are contributing to slow economic growth in the healthcare sector. PricewaterhouseCoopers projected a 6.5% medical cost trend
and new depths of medical inflation in 2014. A report by PwC called this sluggish growth prosect the "new normal" for healthcare organizations.
The heart/mind connection: Rapid heart rate linked to memory problems
People who develop atrial fibrillation
are more at risk for memory and cognition problems, according to a new study in the journal
Neurology. The study examined people over 65 without a history of atrial fibrillation at the start of a 7-year monitoring process. The study found that those who developed heart irregularities were more likely to have memory problems earlier in life.
Study pairs specific pancreatic cancer treatments with genetic profiles
A Phase II trial is being launched at the University of Michigan to evaluate if different pancreatic cancer treatments can be paired with specific genetic profiles for better survival outcomes. The trial will examine patients with non-responsive metastatic prostate cancer.
"We hope this study will help us understand why certain patients respond to therapy and certain patients do not. By better understanding the evolving biology of prostate cancer, we will have the ability to better treat the disease," said principal investigator Dr. Maha Hussain.