Plan B decision made before data review: FDA staff

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The decision whether the U.S. Food and Drug Administration should approve wider access to a morning-after contraceptive drug was made well before agency scientists finished their final review, two FDA officials said in court documents released on Thursday.

Supporters of over-the-counter sales for Barr Pharmaceuticals Inc.’s Plan B pills have accused top FDA officials of hindering the company’s bid for nonprescription sales for years, to please conservative supporters of President George W. Bush’s administration.

The documents come just days after the FDA said it would reopen discussions over the drug, which can prevent pregnancy if taken within 72 hours of sexual intercourse. The delay had stirred debate over politics and science and held up the confirmation of two agency chiefs.

In a sworn statement in June, Dr. John Jenkins, director of the FDA’s Office of New Drugs, said he learned in early 2004 that then-FDA Commissioner Mark McClellan had decided against approval before the staff could complete their analysis.

Plan B was rejected in May 2004, shortly after McClellan left the agency.

“I think many of us were very concerned that there were policy or political issues that came to play in the decision,” Jenkins said in a deposition for a suit by the Center for Reproductive Rights that seeks easier access to Plan B. Jenkins later said he did not know if anyone outside FDA influenced the decision.

Another FDA official, who evaluated Plan B, alluded to White House involvement in a deposition given last month.

Dr. Florence Houn said she was also told that in January by Deputy Commissioner Dr. Janet Woodcock that Plan B needed to be rejected “to appease the administration’s constituents” but that it could be approved later.

McClellan, who led the FDA when Barr submitted its application in 2003, said he gave updates to the White House as a matter of course but denied they told him what to do.

“If I was being given any direction on how I should act on this application, I would have remembered that because that never happened,” McClellan said in a June sworn statement.

The FDA said on Monday it was willing to reopen discussions over the drug. The agency proposed sales from behind the pharmacy counter for women 18 and older.

Opponents say easier access to Plan B will spur promiscuity. Some equate the drug with an abortion pill, although the FDA says it is a contraceptive.

Supporters, who argue wider sales could reduce abortions, say behind-the-counter sales raise privacy concerns and point out that a growing number of pharmacists refuse to dispense birth control.

Simon Heller, lead attorney for the Center for Reproductive Rights, said those concerns mean the suit will continue even if Plan B wins restricted approval.

Barr filed an amended application in 2004 to allow nonprescription sales to those 16 and older. Last year the FDA postponed making any decision on Plan B, which is sold without a prescription in nine U.S. states. Emergency contraception is also available over-the-counter in dozens of other countries.

Agency officials have said the initial rejection of Plan B was based on the lack of data over whether younger girls could use the product safely. Other FDA officials previously said that they were left out of the decision to postpone a ruling.

Heller said the group does not plan to call on Acting FDA Commissioner Andrew von Eschenbach for a sworn statement. A Senate committee hearing on von Eschenbach’s nomination to lead the agency was held on Tuesday.

FDA spokeswoman Susan Bro declined to comment on the suit. “What matters is where we are today (on Plan B).”

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