Group Seeks To Determine Whether White House Pressured FDA on Plan B

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A reproductive rights group is attempting to subpoena White House records in what it says is an effort to determine whether a domestic policy adviser to President Bush put political pressure on the Food and Drug Administration to restrict access to a “morning-after” pill.

In federal court in Brooklyn yesterday, a lawyer for the Manhattan-based Center for Reproductive Rights said it wants to examine the communications that the White House had with FDA officials when the agency was reviewing whether the drug, called Plan B, was suitable for over the counter sale.

Just this week, two years after the FDA first rejected Plan B for over the counter sale, the agency announced signaled that it intended to allow the drug to be sold without a prescription to people over 18.

The government’s decisions regarding Plan B have always been a politically charged topic because opinions differ over whether the pill is contraception or is tantamount to an abortion. In U.S. District Court in Brooklyn, the Center for Reproductive Rights has sued the government over its 2004 decision to reject Plan B for over the counter sale.

Yesterday, the reproductive rights group released four depositions that it conducted of current and former FDA officials and doctors, including those of the FDA commissioner during the time of the decision and of the doctor in charge of the group that reviewed Plan B.

A transcript of one deposition records the doctor, Florence Houn, saying that during the first months of 2004 she was told that politics and not scientific inquiry would determine the FDA’s decision regarding Plan B.

Dr. Houn was the director in charge of the drug research group overseeing the Plan B application. She said she received the phone call in mid-January of 2004 from a deputy commissioner at the agency, Janet Woodcock, to discuss a recent meeting about Plan B.

During that phone call, Dr.Woodcock told Dr. Houn that “the only way to go [sic] to issue a non-approval letter to appease the administration’s constituents, and then later this could be approved,” Dr. Houn said in her deposition.

In May 2004 the FDA rejected the application by Plan B’s makers, Barr Pharmaceuticals, to allow Plan B to be sold without a prescription. At the time it explained its decision in terms of having too little data on the drug’s effect on young teenagers, according to news reports.

A spokesman for the Center for Reproductive Rights, Todd Glass, said that the content of Dr. Houn’s deposition “is enough for us to justify subpoenaing the White House.”

In a recent letter to a magistrate judge handling the case, Viktor Pohorelsky, the government indicated that it would oppose turning over White House records as part of the litigation.

In a separate deposition that was also released yesterday, the man who was commissioner of the FDA at the time, Mark McClellan, said that his contact with the White House over the status of Plan B was routine.

In his deposition Dr. McClellan said that his communications with a domestic policy adviser to President Bush, Jay Lefkowitz, about Plan B consisted only of routine updates for the purpose of allowing the administration to field press calls and stay informed.

Dr. McClellan said in the deposition: “They certainly didn’t direct me to take any actions related to how the Agency was handling the product.”

Dr. McClellan noted that conversations with the White House over a particular drug or health issue were not unusual. He said he also briefed the White House on his agency decision to sell the drug Prilosec over the counter and that he was in contact with the White House to discuss a claim by Iran that scientists there had cloned a human.


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