For FDA nominee, does the White House have a Plan B?

Mounting obstacles to the confirmation of Lester Crawford as commissioner of the Food and Drug Administration (FDA) are contributing to a growing atmosphere of uncertainty about the agency and the drug industry it regulates. The controversial nominee, who has run the beleaguered FDA for a total of 20 months under President Bush, has been enjoined by his superiors from appearing before Congress to speak for the agency.
Mounting obstacles to the confirmation of Lester Crawford as commissioner of the Food and Drug Administration (FDA) are contributing to a growing atmosphere of uncertainty about the agency and the drug industry it regulates.

The controversial nominee, who has run the beleaguered FDA for a total of 20 months under President Bush, has been enjoined by his superiors from appearing before Congress to speak for the agency.
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Lester Crawford has served a turbulent 20 months as acting FDA commissioner.


Crawford’s tenure as acting commissioner of the FDA since March 2004 has been rife with bad news for the agency and the pharmaceutical industry. He was nominated by Bush in February and previously served as acting commissioner from March 2002 to November 2002.

Crawford has stood watch over the withdrawals of Vioxx and other popular prescription painkillers, a shortage of flu vaccine, the addition of suicide warnings for adolescents to antidepressant drug labels, and a bitter fight over permitting over-the-counter sales of the emergency contraceptive Plan B.

The administration has sparked the ire of some in Congress by refusing to allow Crawford, a veterinarian and pharmacologist, to testify before any committees while his nomination is pending, even though he is the most senior official at the agency.

A spokesman for the Department of Health and Human Services (HHS) said, Dr. Crawford is in the odd but rare position of being both the acting commissioner and the FDA nominee. Naturally, protocol dictates that nominees are deferential to the Senate committee with jurisdiction, in this case the HELP [Health, Education, Labor and Pensions] Committee.”

HHS offered the subcommittee another agency official as a stand-in, said the department’s spokesman, who added that the department’s legislative affairs offices also strive to satisfy congressional requests for information.

An aide to HELP Committee Chairman Mike Enzi (R-Wyo.) said, "The prohibition on testifying … is standard operating procedure." HELP ranking member Edward Kennedy’s (D-Mass.) spokeswoman said, “Kennedy would hope that, if [Crawford’s] thoughts were needed at a hearing, that the administration would make him available.”

The administration’s position on Crawford’s committee appearances has caused congressional dissatisfaction with the leadership of the FDA to cross over to the House on Monday, when the House Appropriations Committee’s Agriculture Subcommittee, which funds the FDA, approved an amendment to deny Crawford’s office 5 percent of its budget for fiscal year 2006.

The amendment, sponsored by ranking member Rep. Rosa DeLauro (D-Conn.) and approved by voice vote, indicates the panel’s displeasure that Crawford has not appeared to present the FDA budget request.
“I don't think it is too much to ask the head of the agency to come before Congress in person to explain this request and to answer our questions in public. Stonewalling on testifying will not stop the questions,” DeLauro said.

The policy on Crawford’s appearing before Congress should put pressure on the Senate to move forward with his confirmation, the HHS spokesman said.

Crawford already faces two threatened holds on a Senate floor vote. In addition, the HELP Committee postponed its vote after allegations surfaced about Crawford’s personal conduct at the FDA. The HHS Office of the Inspector General is investigating the charges, which have been reported in news accounts but not confirmed by the administration.

HHS investigators are “keeping their own counsel” and Enzi has no indication when a vote might be possible but continues to support Crawford for FDA chief, his spokesman said.

Observers on both sides of the political spectrum, on and off Capitol Hill, agree that — apart from the personal allegations — few of the roadblocks to Crawford’s nomination would recede if he were to step aside. If the White House names another nominee, he or she would face similar challenges.

During the 14 months since Crawford took over at the FDA, the agency has suffered several black eyes. The Vioxx debacle, in particular, triggered congressional interest in beefing up the FDA’s drug-safety regime.

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and others have scrutinized the agency’s oversight of the industry and proposed legislation that drug companies maintain would slow the approval of new medicines. The FDA has proposed taking its own steps to bolsters its efforts to track the safety of drugs already on the market.

Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) have vowed to block a nomination floor vote until the FDA issues a decision on Plan B. The agency overruled two advisory committees and the advice of its review staff when it rejected Barr Laboratories’ application and has repeatedly delayed a final decision on the drug, which prevents pregnancy when used after unprotected sex but which opponents maintain also can abort early pregnancies in some cases.

Sen. Tom Coburn (R-Okla.) has promised a hold of his own. While a member of the House, Coburn authored a provision in a 2000 law that requires the FDA to change condom labeling to include warnings that condoms do not protect against the human papilloma virus (HPV). The White House currently is reviewing a draft of the regulation.

Crawford’s position at the FDA is viewed as tenuous because he serves only in an acting capacity and has been moved out of the spotlight since his nomination became mired in controversy and political squabbling.

Crawford has been acting commissioner since Mark McClellan left last March to run the Centers for Medicare and Medicaid Services. In 2002, Crawford relieved Bernard Schwetz’s 14-month command until McClellan came aboard in November 2002.

Industry groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA) that enthusiastically welcomed the president’s decision to nominate Crawford have been notably quiet. The drug, biotechnology and medical-device industries remain in a holding pattern, waiting for stable leadership at the FDA.

“FDA has suffered without a confirmed commissioner,” PhRMA President and CEO Billy Tauzin said earlier this month.

Two weeks ago, Biotechnology Industry Organization (BIO) President Jim Greenwood said, “It’s a big deal for this reason: Right now we’re seeing some skittishness in the investment community with regard to biotechnology.” He explained that “the stakeholders here [at BIO] — the companies and their investors — just aren’t sure what to expect, and uncertainty always scares off investors.”

The Advanced Medical Technology Association also believes that “the lack of leadership at FDA is a problem,” a spokesman said.

The spokesman maintained that device companies are not being impeded in their regular dealings with the FDA and have not heard complaints from Wall Street.

A PhRMA spokesman also stressed that the organization has not seen evidence that the holdup over Crawford has impeded its member companies’ ability to conduct business.

“The commissioner has almost nothing to do with the day-to-day operations of the agency,” said Ira Loss, a senior health analyst at Washington Analysis, a firm that advises investors on federal policy.

Unease about Crawford’s position at the FDA is understandable, Loss emphasized, and the importance of having a commissioner should not be underestimated.

An agency chief’s primary role is to “absorb and deflect criticisms of the agency in times of crisis,” which Crawford has not successfully done, said Loss.

Although there have been no concrete signals that the problems with Crawford and the FDA have slowed the drug approval process, the uncertainty is one reason why some biotech stocks have underperformed in recent months, said S.G. Cowen senior biotech analyst Eric Schmidt.