Tuesday, August 30, 2005

Plan B and Mike Leavitt

Did the FDA trick U.S. Senators, seasoned activists, reporters, and you and me into believing it intended to reach a decision on OTC availability of Plan B by September 1, 2005?

Let us see, shall we?

Health and Human Services Secretary Mike Leavitt today offered an explanation for the FDA's failure to decide if Plan B's may be sold OTC by Sept. 1:

U.S. Health and Human Services Secretary Mike Leavitt on Monday defended the Food and Drug Administration's delayed ruling on over-the-counter access for a "morning-after" pill, saying officials never guaranteed a "yes or no" decision by this week.

On Friday, the FDA postponed a ruling on Barr Laboratories' Plan B emergency contraception because it said officials are unsure how to enforce a prescription requirement for younger girls while easing access for women over 16.

"We did take a step forward in the process," Leavitt said. "Sometimes action isn't always yes and no. Sometimes it requires additional thought."

The FDA, which is part of Leavitt's department, called for 60 days of public comment but gave no further deadlines.

Supporters and critics of the controversial drug expected the FDA to rule by Thursday, when Leavitt and FDA Commissioner Lester Crawford said the agency would act.

"FDA made their commitment to me and I made my commitment to the senators," Leavitt said. "The commitment was they would act. They did."

Democratic Sens. Patty Murray of Washington and Hillary Clinton of New York, who both dropped objections over Crawford's nomination as commissioner based on that pledge, said Leavitt was playing "word games."

"A delay is not a decision and no amount of semantics can change that," they said in a joint statement.

As you may recall, I was quite critical of Sens. Murray and Clinton. I thought they were being disingenuous, pretending to believe FDA's assurances about a decision on Plan B so that they could reach some type of deal on the nomination of Lester Crawford as head of the FDA in order to benefit their political careers .

But what if the two Senators took FDA's promise at face value? In fact, what if the FDA never promised to reach a decision on Plan B by September 1st?

It appears all this talk about a "guarantee" from the FDA is based on a letter from Secretary Leavitt to Sen. Mike Enzi (R-Wyo.). This July 16, 2005 article from the Washington Post has the story [emphasis mine]:

The nomination of Lester M. Crawford, the administration's embattled choice to head the Food and Drug Administration, got a boost yesterday when three senators agreed to lift their holds and allow a vote on the Senate floor.


Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) announced their decision to lift their holds on the nomination after receiving written assurances that the agency will decide by Sept. 1 whether to allow sale of the emergency contraceptive Plan B without a doctor's prescription.


"While we continue to have concerns about the lack of leadership and independent decision-making that Dr. Crawford and the FDA have shown in this case, we have been clear all along that our hold on this nomination is about one thing only: the FDA's failure to provide an answer on Plan B," they said.

The assurance of a decision by Sept. 1 came in a letter from Health and Human Services Secretary Mike Leavitt to Sen. Mike Enzi (R-Wyo.), chairman of the committee that voted to endorse Crawford's appointment. "I have spoken to the FDA," Leavitt wrote, "and, based on the feedback I have received, the FDA will act on this application by September 1, 2005."

One more thing of note from the article:

Leavitt's statement that the Plan B application will be acted on by Sept. 1 was welcomed by women's health advocates, who said a decision is overdue.

"President Bush's FDA has 46 days until they must decide whether to side with the doctors and scientists who overwhelmingly support giving women over-the-counter access to the pill or, once again, cave in to the anti-birth-control radical right," said Nancy Keenan, president of NARAL Pro-Choice America. "The 'morning-after' pill is a safe, effective way to help women prevent unintended pregnancies."

So, Secretary Leavitt's letter clearly states that the FDA will act on Barr Labs' application.

Two career politicians, one experienced NARAL president, and countless others understand FDA's stated intention to act on this application by September 1, 2005 to mean that, by that date, the FDA will make a decision (of the "yes or no" variety) regarding the OTC availability of Plan B.

Finally, today it is explained to us by Secretary Leavitt what the meaning of act on this application by September 1, 2005 is. [What is it with these politicians and their penchant for redefining common words to suit their scheme du jour?]

According to the FDA, act on this application [to allow Plan B to be available OTC] by September 1, 2005 means 1) make no decision about allowing Plan B to be sold OTC, 2) ask for 60 days of public comment, and, last but not least 3) give no further timetable or deadlines for deciding if Plan B should be available OTC.

Secretary Leavitt calls FDA's latest action on the availability of Plan B a step forward in the process. [Ah, the warm, tingly feeling one must get from being a powerful politician condescending to the peons!] I beg to differ.

Here's the timeline for Barr Labs' FDA application for OTC availability of Plan B:

April 22, 2003

  • FDA receives Barr Labs' supplemental new drug application proposing nonprescription (OTC) availability of Plan B.

  • According to the Prescription Drug User Fee Act (PDUFA), the FDA has until February 20, 2004 decide if Plan B can be sold OTC.

    [Basically PDUFA is a type of legalized extortion (whatever would we do without the hard work of our beloved politicians!): the Pharmas "agree" to, and do pay the FDA hundreds of millions of dollars in "fees" (~$137.7 million for FY 2000). In return, the FDA agrees to, you know, have some standards. (The FDA agrees to a set of performance standards intended to reduce the approval time for drug applications.)]

    December 2003

  • Following a meeting of the FDA's Nonprescription Drugs and Reproductive Health Drugs Advisory Committees, two FDA advisory panels vote 23-4 to recommend approval of the sale of Plan B without a prescription.

    Feb. 13, 2004

  • FDA extends the original 10-month PDUFA deadline for completion of its review of the Plan B application. According to Barr: The PDUFA extension will permit the FDA to complete its review of the application, including additional data on adolescent use that was submitted by Barr and WCC in support of the application.

    May 2004

  • FDA issues a "not approvable" letter, which cites inadequate data on the use of the pills among girls ages 16 and younger. According to this: FDA scientists disagreed with the agency's finding that there was not enough information on how Plan B would affect the sexual behavior of younger women....

    January 5, 2005

  • JAMA study concludes: Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.

    July 22, 2004

  • Following FDA's suggestion contained in the "not approvable" letter, Barr Labs resubmits its application to the FDA to sell Plan B OTC to individuals age 16 and older. [Can you say age discrimination?]

    Aug. 26, 2005

  • FDA informs Barr Labs of its decision to delay any action on Barr's application seeking OTC status for Plan B.

  • According to Barr Labs, the letter they received from the FDA states that "the Center for Drug Evaluation and Research ... has completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an OTC product ... for women who are 17 years of age and older."

  • FDA informs Barr Labs that it intends to seek public comment on issues related to the approval of a product that has OTC status for patients 17 and older and prescription status for patients 16 and under.

  • Finally, according to Barr Labs (emphasis mine): In its communication with the Company, the FDA did not commit to any timetable for initiating or concluding the rulemaking proceeding.

    One step forward in the regulatory process of Plan B, according to HHS Secretary Mike Leavitt and the FDA. One giant leap backward for women's health, according to reality.



    At 3:38 AM, Blogger Dr. Charles said...

    you are so thorough in exposing this delay, whether it's beauracratic or intentional, i'd suspect the latter as well.


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