FDA nominee is grilled

Senate Democrats link confirmation to sale of morning-after pill

August 02, 2006|By JONATHAN D. ROCKOFF AND STEPHANIE BEASLEY | JONATHAN D. ROCKOFF AND STEPHANIE BEASLEY,SUN REPORTERS

WASHINGTON -- Senate Democrats confronted President Bush's nominee to run the Food and Drug Administration during a testy confirmation hearing yesterday that centered on the agency's delay in approving over-the-counter sales of the morning-after pill.

Dr. Andrew C. von Eschenbach, acting FDA head, had sought to blunt the expected attacks on his nomination with an abrupt overture Monday to the emergency contraceptive's maker for talks to pave the way for sales to some women without a prescription.

But throughout the 2 1/2 -hour hearing, Democrats assailed the gesture as the latest instance of politics trumping science in the case of a drug that the FDA staff has determined is safe and works.

Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington vowed to continue blocking confirmation until the FDA accepts or rejects over-the-counter sales.

"This a slippery, dangerous slope we're on, Doctor, and we are looking to get a decision made," Clinton said.

Von Eschenbach, who has been acting FDA commissioner since September and was nominated in March, countered that he was moving toward approval of the drug, based on a careful analysis of study data and after a review of 47,000 comments from the public. He described Monday's move as a significant step and said his aim was to protect public health.

"No one told me what I should or could do. No one told me what decision I must or must not make. This was my decision," he said.

A high dose of birth control, the morning-after pill is actually a regimen of two pills, the first taken within 72 hours of sex followed by a second 12 hours later. Since 1999, it has been available in the United States by prescription. In 2003, Plan B's maker, now called Barr Pharmaceuticals Inc., first asked the FDA for permission to sell Plan B to women of all ages without a prescription.

Under von Eschenbach's proposal, Barr Pharmaceuticals would have to agree to a plan that would ensure that women under 18 years of age would use the drug with the help and guidance of a medical professional. He also told the company it would have to ensure that the drug wouldn't be used by girls without supervision of a medical professional.

Both conditions for final approval nettled the committee's Democrats, who criticized the demands as unprecedented and unnecessary obstacles.

"Science has been trumped by ideological concerns - that's what's going on here," said Sen. Tom Harkin of Iowa.

Von Eschenbach testified that data he reviewed were not adequate to conclude that teenage girls could take Plan B safely without supervision, and therefore the company should have a plan for preventing underage use.

His stance angered some conservatives, who say easier access to Plan B will encourage promiscuity and increase the spread of sexually transmitted diseases. The Family Research Council sent a letter to Sen. Michael B. Enzi, a Wyoming Republican, opposing von Eschenbach's confirmation partly over his effort to finalize approval of the morning-after pill.

"Dr. von Eschenbach has shown a history of ignoring any concern for women's health in exchange for political expediency," FRC Vice President Tom McClusky wrote.

Enzi, who chairs the Senate Health committee, said he intended to hold a vote after Congress returns from its August recess.

"The question is not whether to confirm him. The question is whether to confirm him before Plan B is approved," said Enzi. "So it's not a question of qualifications."

Despite their differences over Plan B, all sides praised the credentials of von Eschenbach, a three-time cancer survivor, a cancer surgeon and chief academic officer of the M.D. Anderson Cancer Center in Houston. He is a Bush family friend whom the president first placed in charge of the National Cancer Institute, which conducts research into the disease.

Democratic Sen. Barbara A. Mikulski of Maryland said the next commissioner must bolster an agency suffering from poor morale and inadequate oversight of drug safety. Mikulski said scientists are leaving the FDA because they feel agency decision-making is influenced by politics.

Von Eschenbach said his first priority would be addressing the concerns of agency staff, and he would do so by modernizing the agency's operations.

He dismissed the oft-discussed proposal to establish an independent office for monitoring the safety of drugs and medical devices after they go on sale, saying the agency is capable of performing that task.

Mikulski replied, "You see our concern is that the current FDA hasn't been working."

jonathan.rockoff@baltsun.com stephanie.beasley@baltsun.com

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