A Medical Device Daily

The Obama administration has released its proposed budget for FDA for fiscal year 2010, and if the White House gets its way, the agency may have in excess of $3 billion to work with for the year starting Oct. 1. The one feature of the proposal that is sure to rankle health advocates and industry alike, however, is a growing propensity to rely on user fees to fund the agency's operations.

According to a May 7 FDA statement, the $3.2 billion request constitutes a 19% increase from the agency's funding in the current fiscal cycle, but of the roughly $410 million increase itemized in the FDA statement, only $295 million comes out of the taxpayer pocket and another $215 million would be paid in industry user fees. User fees would account for more than 40% of the increased FDA funding.

Much of the increase would fund a pair of initiatives dubbed Protecting America's Food Supply and Safer Medical Products, at approximately $259 million and $166 million, respectively. However, the numbers do not indicate that the White House expects to have to fund an FDA tobacco regime, a proposition that is drawing mixed reviews on Capitol Hill (see item below).

Acting FDA Commissioner Joshua Sharfstein, MD, said in the statement that the "historic increase in the FDA's budget is a great investment in public health."

In a May 7 statement, Stephen Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said the association "applauds the Obama Administration for providing a significant increase to FDA's medical device program budget for FY 2010," a reference to the boost to funds for the Center for Devices and Radiological Health from $280 million to $315 million. Ubl also stated that AdvaMed would urge Congress "to expeditiously approve the president's budget request."

Hamburg amenable to FDA tobacco regs

Margaret Hamburg, MD, the Obama administration's nominee for the commissioner's job at FDA, testified last week before a Senate committee that she would not be averse to adding tobacco regulation to the agency's portfolio.

According to Congressional Quarterly, Hamburg made the case that FDA's regulatory regime could reduce smoking and cut down on nicotine levels in cigarettes. "I think the FDA is the appropriate agency to regulate tobacco," she said.

The House of Representatives passed a bill that would put FDA in charge of tobacco by a vote of 298-112. The Family Smoking Prevention and Tobacco Control Act of 2009 (H.R. 1256) would give the agency the ability to regulate the promotion of and chemical content of tobacco products. The senate's version, S. 982, was referred to the Senate Health, Education Labor and Pensions Committee last week. How such a set of responsibilities would be funded is an open question, but FDA might in any event not be in a position to set up a regulatory scheme until next year, assuming the Senate bill passes in 2009.

Senate Health, Education, Labor and Pensions Committee members have until the end of this week to submit questions to Hamburg for the record, but a vote in the committee could come at any time. By several accounts, no GOP members seemed inclined to vote against Hamburg's bid.

Blumenthal names committees

David Blumenthal, MD, who holds the post of the national coordinator for healthcare information technology, announced Friday the names of those who will sit on two boards that will heavily influence the course of the government's HIT program.

Blumenthal said his office is "totally focused on implementing the President's agenda" for HIT, and that "my personal experience as a physician for many years" validated the power of HIT. He also remarked that his use of HIT "totally transformed my work" and "prevented me from prescribing duplicative testing" and from writing inappropriate prescriptions.

Blumenthal stated that the two committees in question, the Health IT Policy Committee and Health IT Standards Committee, will be more than up to their respective tasks, remarking that the government is "very fortunate to have a very distinguished and knowledgeable people" for the panels.

The policy committee will feature Blumenthal and Michael Klag, MD, the dean of the Bloomberg School of Public Health at Johns Hopkins University (Baltimore). Among the members of the standards committee are Jonathan Perlin, MD, chairman of Healthcare Corporation of America (Nashville, Tennessee), John Halamka, MD, chief information officer at Harvard Medical School (Boston), and Dixie Baker, PhD, of government IT contractor Science Applications International (San Diego).

Regarding the phrase "meaningful user," Blumenthal said "those two words are key to the success of the policy over the next few years," but that no definition has been set in stone, although a set of definitions has been offered by the Chicago-based Healthcare Information and Management Systems Society (Medical Device Daily, May 4, 2009). Blumenthal noted, "We hope to provide a direction as to some specification in late spring or early summer."