Like FDA, Medicare agency could be hampered by leadership vacancy

The nation’s two highest-profile and most embattled health agencies are likely to head into 2007 facing questions about the status of their senior leaders.

A Senate committee yesterday approved President Bush’s nominee, Andrew von Eschenbach, to oversee the Food and Drug Administration (FDA), but the panel’s actions might not clear the path for his confirmation, which has been targeted with holds by two Republican senators.

Meanwhile, Mark McClellan is due within weeks to leave the Centers for Medicare and Medicaid Services (CMS), which he has run since March of 2004. His departure will leave CMS in the hands of experienced deputies but almost certainly without a permanent head until at least early next year.

Between them, these agencies have far-reaching authorities and responsibilities. The FDA is responsible for monitoring the safety of medical products and the food supply, while CMS oversees massive healthcare-benefits programs that cover more than 80 million people.

Both are confronted with a myriad of political and administrative challenges of the sort that lawmakers repeatedly say require permanent, Senate-confirmed chiefs.

Former senior officials from the FDA and CMS bemoaned the difficulties that can confront an agency and its leadership in the absence of Senate confirmation.

“It’s just hard to take more aggressive, bold positions” without Senate confirmation, said Tom Scully, who headed CMS from 2001 until 2003, adding, “It’s always better to have somebody in there who’s confirmed.” Scully is now a lobbyist at Alston & Bird and a partner at the investment firm Welsh, Carson, Anderson and Stowe.

William Schultz, a former FDA deputy commissioner and a partner at Zuckerman Spaeder, said, “It can be difficult for an acting commissioner to make decisions on important but potentially political issues. ... It’s bad for the morale of the FDA.”

The head of one good-government group said that an acting official could lack the authority to assert the agency’s needs to Congress and the administration. OMB Watch Executive Director Gary Bass also said the agency head also might not be able to earn staff loyalty because of their uncertainty over the agency’s future direction.

Although the senior leadership is not directly involved in most of the agency’s day-to-day activities, big problems can go unaddressed, said Peter Lurie, deputy director of Public Citizen’s Health Research Group, who is a frequent critic of the FDA. “‘Acting’ people are probably less likely to take on broad, ambitious issues.”

The FDA has been the subject of intense criticism in recent years for its record on ensuring the safety of drugs and other medical products, and has been caught up in the heated politics of abortion and contraception.

It has been without a confirmed commissioner for most of the president’s tenure.

The only confirmed FDA chief during this administration was McClellan, who ran the agency for 16 months until March 2004. McClellan was preceded and succeeded by Lester Crawford, who served two stints as acting head until being confirmed last July. But Crawford unexpectedly stepped down less than three months into his tenure.

Von Eschenbach has been acting commissioner for a year; the president nominated him for the job in March.

FDA commissioners have only required Senate confirmation since 1990. Four commissioners have been confirmed since then.

The Senate Health, Education, Labor and Pensions (HELP) Committee cleared von Eschenbach’s nomination by voice vote yesterday. The FDA’s decision last month to approve the emergency-contraceptive pill Plan B eliminated holds placed on the nominee by two panelists, Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.).

After the committee met, Chairman Mike Enzi (R-Wyo.) issued a statement saying, “We need a strong leader at the FDA right now, one who has a mandate to act.”

But Enzi might not get his wish just yet. GOP Sens. David Vitter (La.) and Jim DeMint (S.C.) have each vowed to block von Eschenbach until they get action on issues of importance to them.

Vitter has been trying to pressure Senate Majority Leader Bill Frist (R-Tenn.) to set aside floor time for his bill to relax restrictions on the importation of prescription drugs from abroad. Vitter also held up Crawford’s nomination until, he maintains, he received a promise of a vote. However, Frist does not characterize their agreement as a promise and has rejected allowing the bill to come to the floor this year.

Meanwhile, DeMint has vowed to block any FDA nominee until the agency begins the process of withdrawing the prescription abortion pill known as RU-486 from the market, citing unanswered questions about women who died after taking the drug.

DeMint does not intend to back down from his hold, a spokesman said. “The senator continues to work with the administration, the FDA and the [HELP] Committee” but will maintain his hold in the meantime, the spokesman said.

Apart from the holds, support for von Eschenbach in the Senate is considered to be high. Frist could choose to move ahead anyway and force a cloture vote to overcome Vitter and DeMint’s holds, or the president could install von Eschenbach by way of a recess appointment, but both moves would likely engender the enmity of Vitter and DeMint, and possibly more senators who chafe at being excluded from the advise-and-consent process.

The administration faces similar, if less complicated, considerations as it searches for McClellan’s replacement at CMS.

CMS is winding down a difficult first year of implementing the new Medicare Part D prescription-drug benefit, which has been a political football for Democrats and Republicans this election year. Beneficiaries will begin signing up for next year’s benefits barely a month after McClellan is scheduled to exit.

With Congress close to adjourning for the midterm elections, the White House is not expected to announce its pick for the job this month.

If the White House waits until next year to nominate a new CMS administrator, the confirmation process will provide Senate Democrats with another opportunity to hammer away at their criticisms of the Medicare prescription-drug benefit. In the meantime, an acting chief will have to oversee the enrollment period for Part D, which was fraught with problems at the beginning of this year.