A Medical Device Daily

The Government Accountability Office is not necessarily charged with dispensing information that would strike the recipient as novel, but that's usually the hope when Congress instructs GAO with a particular task. GAO's latest review of FDA's funding needs, however, struck the same old chord: FDA is starved for resources.

According to the report, which was posted July 20, "funding and staffing resources for FDA's medical products programs increased between fiscal years 1999 and 2008 primarily as a result of increased user fees." The report specifies that user fees accounted for 69% of medical product program funding in 2008, said to total $1.2 billion. In 1999, user fees accounted for 48% of the $562 million going into the centers dealing with drugs, devices and biologics.

Opponents of user fees might not be surprised at the numbers, but were surely dismayed to see that Congress' latest funding boost for FDA also was provided primarily by user fees (Medical Device Daily, July 13, 2009), which are expected to make up roughly a third of the agency's overall budget.

GAO notes that it had studied FDA's predicament 20 years ago and found essentially the same state of affairs. The GAO document also states that while "funding amounts requested for and provided to FDA during the past two years will permit the agency to respond to its most urgent needs and priorities," the agency's management "also noted that they did not receive enough resources to meet some statutory requirements, such as biennially inspecting certain manufacturing establishments." The agency's managers also told GAO that FDA – which Congress routinely likes to refer to as "the world's most important public health agency" – faces "significant challenges fulfilling its mission to oversee the safety and effectiveness of medical products."

DoD announces grants for SCI research

The Office of Congressionally Directed Medical Research Programs (CDMRP) at the Department of Defense has announced another series of grants to be awarded, this time for research into therapeutics for spinal cord injury, or SCI.

According to the July 14 announcement, CDMRP will offer as much as $1.5 million for as many as four clinical trials that examine rehabilitative aspects of SCI. Investigators must be at the assistant professor level or higher in order to qualify for the grants, and those trials should be finished within four years of the award date. Applicants should have their paperwork in by Dec. 10.

Another grant, this one funded with $750,000 for up to five awards over three years, will go toward translational research "that accelerates the movement of promising ideas in SCI research into clinical applications." Applicants for this grant should have their applications in by Dec. 10 also.

Among the remaining three grant areas is one dealing with development of novel "diagnostics, therapies or clinical policy/guidance that have the potential to make a strong impact on patient care." Clinical trials are not candidates for this grant, which will provide as much as $1.4 million to as many as three applicants, who each have three years to complete their work.

A third of uninsured make 3 times FPL

Much of the healthcare debate is driven by the idea that those who are uninsured are in that state of affairs involuntarily, but a new paper has argued that this assumption is not particularly well grounded.

According to a June 24 paper by former director of the Congressional Budget Office June O'Neill, PhD, "a large fraction of the uninsured could likely afford health coverage" in reference to the estimated 47 million living in the U.S. without healthcare coverage. O'Neill's paper also says that "while the uninsured use fewer health services, they still receive a large amount of care, and there is little discernable difference in mortality based on insurance status."

O'Neill uses a threshold of 2.5 times the federal poverty level (FPL) as a general index of voluntary uninsurance. While many whose incomes are below this line do have private insurance (60.8%), the study assumes that anyone in this group who is uninsured is in that state due to factors beyond their control. The study also disclosed that more than 35% of those whose incomes are below 1.25% of the FPL have private insurance.

Interestingly, more than 20% of those whose incomes exceed the FPL by between 2.75 and 3.5 are not enrolled in private insurance. This group is numerically pegged at more than six million U.S. residents. Odder yet is that more than 10 million U.S. residents whose incomes exceed FPL by a factor of at least 3.75 choose to go uninsured, a group that makes up more than 11% of those in that income level.

The analysis led to the conclusion that those whose incomes are lower than 2.5 times the FPL make up 57% of the uninsured and that those whose incomes are less than three times the FPL account for only 65% of the uninsured. Healthcare reform legislation passed by the Senate Health, Education, Labor and Pensions Committee earlier this year would provide subsidies for families making four times FPL.