Medical Device Daily Washington Editor

WASHINGTON – Room 430 in the Dirksen Senate Office Building was packed yesterday as the Senate Heath, Education, Labor and Pensions (HELP) Committee took up the nomination of former Sen. Tom Daschle for the post of Secretary of Health and Human Services, but the hearing also served to mark the return of Sen. Ted Kennedy (D-Massachusetts) to Capitol Hill after a bout with glioblastoma multiforme, perhaps the deadliest of the cancers of the brain.

While the welcome wagon rolled generously for both Daschle and Kennedy – who looked remarkably hale considering his age and health status – the committee's Republican members sounded a cautionary note about any attempts to approach healthcare reform in any manner that suggests sharp-elbowed partisanship.

Among the witnesses who appeared in support of Daschle's nomination was Bob Dole, the former Republican senator from Kansas who served as the GOP leader following the 1994 elections. Regarding his and Daschle's time in the Senate, Dole said, "I served with Tom for 10 years, including two years when we both served as our parties' leaders." He said he could "testify not only to his expertise on the issues," but also to "Tom's integrity and fairness, which I think gives everybody confidence" in his ability to run the nation's largest governmental department.

Dole stated that the incoming administration of President-elect Barack Obama "has selected an individual who will begin the task of reforming healthcare with the ability to hit the ground running," and mentioned "the fact that he understands Congress" from both ends, thanks to Daschle's service in both the House and the Senate.

"With a solid Democratic majority, you may not need Republicans," to pass a healthcare reform bill, Dole said, but he urged the committee to move in a bipartisan fashion.

In his opening remarks, Kennedy, who chairs the committee for the 110th Congress, said "Tom Daschle is a leader of great integrity and strong dedication." He asserted that Daschle "has admirers all across the country and on both sides of the aisle."

"Reform is urgently needed, and Tom Daschle is just the man for the job," Kennedy said.

Sen. Mike Enzi (R-Wyoming), the ranking Republican member of the HELP committee, welcomed Kennedy back to the Senate, then offered a cautionary note on the topic of healthcare reform. He said he hopes for an emphasis in the 111th Congress "on legislation on what we can agree on, not on what divides us." Enzi stated that draft legislation sometimes consists of "80% what we can agree on [and] 20% on what we can discuss forever."

Enzi said "there are going to be areas on which we disagree," but said that Congress could ensure success if it worked to "meet the 80% rule and do it through the committee process" in a way that seeks "solutions, not just debate." He also reiterated a "shared commitment to insuring uninsured Americans and containing costs."

Daschle said the department "has a significant role to play in keeping America healthy," and is central to "reforming our healthcare system" because of the increasingly central role that public health programs such as Medicare and Medicaid will play in healthcare. He said of healthcare that "the flaws are pervasive and corrosive," hence the need for the White House Office of Health Reform (OHR), which will be dedicated to "making healthcare affordable and accessible to all Americans." Daschle is expected to serve as the inaugural director of OHR.

Saying he is "returning to public service at a pivotal moment," a time in which despite the fact that the U.S. leads the world in innovation, "too often patients don't get our best," Daschle cited the fact that in 1994, 37 million Americans were uninsured, a number that stands today at 46 million.

He echoed the earlier comments about bipartisanship, stating that "any effort at reform will require collaboration." Daschle said that the process of reforming healthcare "also needs to be an open, transparent process" that will give the public a close look at which reforms are put into play.

"The problem of the uninsured is sure to grow" in a recessionary environment, Daschle warned, but he also lamented that "our healthcare system is not oriented toward prevention ... that can do so much to improve health." He stated that a systemic roll-out of preventive care could trim $16 billion annually after five years.

Enzi queried Daschle about his view of a role for FDA in regulating tobacco. "I'm concerned about a regulatory regime that would give legitimacy" to the product, Enzi said. Daschle answered that he sees it as "important to discourage tobacco use in every way we can," citing a need for "an extraordinary educational effort," but he nonetheless acknowledged that he is "inclined to believe FDA can play a very important role in that regard."

All the same, Daschle said that "in no way would I endorse allowing FDA to give its seal of approval," and if anything, the agency "should regulate it in such a way as to discourage" use.

Sen. Richard Burr (R-North Carolina) addressed the FDA resource issue, stating that the agency "is struggling due to lack of funding and low morale and an increasingly expanding mission." He said a company, which he did not name, dropped its pursuit of an NDA for its diabetes drug because the cost of obtaining FDA's stamp of approval would be more than the expected return from the U.S. market. He asked Daschle "how we overcome this in the future," making the case that innovation is an essential ingredient for improvement of healthcare quality and cost control.

Daschle cited four components needed to get FDA on the right track, including resources, but declined to go into specifics. He commented that the resources at HHS could be better leveraged if there was more cooperation between the department's agencies.

"If we did that ... we could really make a difference," Daschle said.