Medical Device Daily Washington Editor
The fiscal year (FY) 2010 budget for FDA passed by the House of Representatives last week sets a target of $2.99 billion for the entire agency, a figure that the legislation says comes in at almost $235 million more than the current fiscal year. However, the bill also makes clear that user fees are expected to carry almost a third of the budgetary load at FDA, a fact that may raise hackles among advocates as the details emerge.
The Center for Devices and Radiological Health enjoyed a more-than-proportional boost of $35 million for FY 2010, bringing the CDRH budget up to $349 million from roughly $314 million, a boost of about 11%. On the other hand, the bill also calls for device and diagnostics makers to cough up more than $57 million in user fees, which accounts for roughly one dollar out of every six in the CDRH budget.
Drug makers are expected to pull a much heftier load where user fees are concerned, although the countervailing argument is that drugmakers have much deeper pockets. Funds dedicated to the Center for Drug Evaluation and Research are expected to come to almost $783 million in fiscal 2010, but user fees from makers of brand-name drugs are expected to provide $578 million to FDA.
User fees from tobacco companies are expected to generate $235 million, according to the final bill, and when adding in the user fees for generic and brand-name veterinary drugs, the portion of FDA's budget to be derived from user fees comes to almost 30%, or almost $895 billion.
The budget, which was initially inked in the House Appropriations Committee's agriculture subcommittee, highlights food safety, a key issue for committee chairwoman, Rep. Rosa DeLauro (D-Connecticut), who earlier this year proposed breaking off FDA's food safety division into a separate agency (Medical Device Daily, Feb. 6, 2009). The expected spending level for the Center for Food Safety and Nutrition in the coming fiscal year, which begins Oct. 1, comes to nearly $783 million. However, FDA splits the food safety task with the Department of Agriculture, home to the Food Safety and Inspection Service, which will be funded at more than $1 billion in fiscal 2010.
The White House had proposed earlier this year to boost the FDA budget to $3.2 billion for 2010, but that figure is unlikely to be met. The current version of the Senate appropriation legislation, which was passed by the Senate Appropriations Committee on July 7, renders essentially the same numbers for FDA as the House bill.
Blue Dogs put brakes on reform bill
A group of fiscal conservatives in the House of Representatives broke ranks last week with the party's majority in the effort to craft a healthcare reform bill. Rep. Mike Ross (D-Arkansas) went public with the group's complaints about the tri-committee healthcare reform bill, saying that the cost of reform is growing out of control.
According to wire service reports, Ross told several other members of the House Democratic Party that the coalition was backing away from its support of the bill, and Ross is reported to have had a similar discussion with White House Chief of Staff Rahm Emanuel. Of his conversation with Emmanuel, Ross is quoted as saying "the message to him was the same as to the leadership, that we could not support the current bill."
On the other hand, the 52-member coalition is said to be agnostic on the tax provisions currently coded into the House bill. Declining to take a stand on those measures, Ross said, "we want to see more savings out of the current system."
The July 9 letter specifically states that the cost element of the House healthcare draft "fails to include adequate structural changes that will succeed in lowering costs and increasing value." The letter argues, "we cannot simply 'add' new consumers to a broken system."
As for a public option, the Blue Dogs make the case that a plan based on Medicare "would negatively impact hospitals, doctors and patients," an argument predicated partly on the fact that "Medicare reimbursement is on average 20%-30% lower than private plans," which they say "would seriously weaken the financial stability of our local hospitals and doctors."
The letter also strikes a blow for bipartisanship, asserting "it is imperative that comprehensive health care [reform] include the ideas of members of Congress from both sides of the aisle," and the signers urged the House majority leadership to avoid a hasty approach to crafting the bill. "Too short a review period is unacceptable and only undermines Congress' ability to pass responsible healthcare reform that works for all Americans," the letter says.
Grassley, Kohl urge transparency at NIH
Two senators have penned a letter to acting NIH director Raynard Kington, MD, urging that NIH become more transparent in its disclosure of financial relationships between industry and researchers doing work on the federal dime.
The July 7 letter, signed by Sens. Chuck Grassley (R-Iowa) Herb Kohl (D-Wisconsin), makes note of a report by the Office of Inspector General (OIG) at the Department of Health and Human Services, which "found that NIH provided almost no oversight of its extramural funds. The two senators describe the situation at NIH as "a pervasive problem that requires an immediate change in NIH requirements for disclosure of potential conflicts of interest among their grantees." The letter recommends that NIH require researchers "report their outside income to the nearest $1,000," and that universities "complete a plan to manage their researchers' potential conflicts of interest." This information, the letter says, should be posted at the NIH web site.