A Washington Times editorial claimed that "[t]he FDA and [Dr. Andrew] von Eschenbach have decided that women 18 and over should have "access" to the contraceptive pill known as Plan B, "while younger women can still get it with a prescription," and that Sens. Hillary Rodham Clinton and Patty Murray are "blocking" [von Eschenbach's] nomination [to head the FDA] until the FDA agrees to make "Plan B ... available without a prescription and without any restrictions on age or access." Both assertions are false.
In an August 7 editorial, The Washington Times made two false claims regarding Sens. Hillary Rodham Clinton (D-NY) and Patty Murray's (D-WA) Senate "holds" on Dr. Andrew von Eschenbach's nomination to head the Food and Drug Administration (FDA). The Times falsely claimed that "[t]he FDA and von Eschenbach have decided that women 18 and over should have ... access" to the contraceptive pill known as Plan B, "while younger women can still get it with a prescription." In fact, the FDA has not "decided" anything; instead, the agency has announced it will "proceed to work" with Plan B's manufacturer, Barr Pharmaceuticals, to "discuss" a "framework for potential approvability" of allowing women 18 and over to obtain Plan B without a prescription.
The editorial also claimed that Clinton and Murray are "blocking the nomination until the FDA agrees to make the contraceptive Plan B ... available without a prescription and without any restrictions on age or access." But that is not what the two senators have said. They issued a press release demanding only that the FDA reach a final decision on the issue.
As Media Matters for America has noted, in May 2004, the FDA's Center for Drug Evaluation and Research (CDER) rejected Barr Pharmaceuticals' application to allow Plan B to be sold over the counter (OTC) to women 16 years and older -- a decision that conflicted with the view of a majority of staff scientists and outside panels involved in the FDA approval process. A November 14, 2005, Government Accountability Office (GAO) report -- as summarized by a November 15, 2005, article in the Los Angeles Times -- found that "[f]ederal drug regulators compromised their usual science-based decision-making process when they ruled in 2004 against letting the 'morning-after' birth control pill be sold without a prescription." As Colorado Media Matters has noted, according to a March 30 Congressional Quarterly article, "Barr reapplied in July 2004 to make it available behind the counter at drugstores and only to women who showed proof they were 16 or older." The FDA, however, has yet to issue a decision on this new application, even though the Senate confirmed the previous FDA commissioner, Dr. Lester Crawford, only after he reportedly promised to issue a decision on Barr Pharmaceuticals' application by September 1, 2005.
The Times editorial claimed that the FDA and von Eschenbach had, in fact, "decided that women 18 and over should have such access while younger women can still get it with a prescription." But, as Colorado Media Matters has documented, von Eschenbach did not "decide" whether Plan B will be available to any women, regardless of age. Rather, on July 31, the FDA announced that "it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option," and that "[t]he Agency and the Sponsor will discuss the Sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older." The Washington Post reported on August 1 that the FDA's "shift in position ... stopped short of a promise that the agency is ready to allow nonprescription sales of the drug." Indeed, von Eschenbach's July 31 letter to Duramed stated that it could still not approve OTC sales, even to adults: "If after our discussions we conclude that the CARESM Program [Duramed's distribution plan] isn't sufficiently rigorous to prevent the OTC version of Plan B from being used by young girls who can't safely use the product without the supervision of a practitioner licensed by law to administer the drug, Plan B will remain Rx-only for women of all ages."
In addition, contrary to the Times' assertion that Clinton and Murray are "blocking the nomination until the FDA agrees to make ... Plan B ... available without a prescription and without any restrictions on age or access," when von Eschenbach's nomination was announced, Clinton and Murray issued a press release on March 15, stating that they would "place a hold on the nomination of Dr. von Eschenbach until the FDA issues a decision on Plan B, yes or no." More recently, an August 1 Clinton press release reiterated that position, announcing that the two senators "would not lift the hold until the FDA makes a decision on Plan B, yes or no."
The Times attributed its claim about Clinton and Murray to an August 7 Times op-ed by Robert Goldberg, vice president for strategic initiatives for the Center for Medicine in the Public Interest (CMPI), and CMPI president Peter Pitts. But Goldberg and Pitts do not make that specific claim. They do, however, imply that Clinton is imposing her politics on the FDA decision process, claiming that she "wants an FDA that acts on the political whims and media-driven factoids of politicians."
From the August 7 Washington Times editorial:
But leadership in limbo undermines authority. It has made it hard for the agency to move forward or respond to congressional overseers who are more interested in promoting their careers than the public health. The holdup can be blamed on Sens. Hillary Clinton and Patty Murray, who, as today's Op-Ed "Distorting science" notes, are blocking his nomination until the FDA agrees to make the contraceptive Plan B, or "morning-after" pill, available without a prescription and without any restrictions on age or access. The FDA and Dr. von Eschenbach have decided that women 18 and over should have such access while younger women can still get it with a prescription. The senators don't want a permanent commissioner. They want a decision that makes their base happy.
Capitulation to this ransom demand would open the FDA up to political manipulation of the rankest sort. This is not about science and health. If it were, Dr. von Eschenbach would be confirmed in a heartbeat. This is about attacking the administration, just as its opponents did when they blocked John Bolton's nomination as U.N. ambassador.
Mr. Bush made Mr. Bolton permanent ambassador through a recess appointment, a decision vindicated by his performance in the job. The president should do the same with Dr. von Eschenbach as FDA chief.