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Kaiser Daily Women's Health Policy Report Summarizes Opinion Pieces Discussing Plan B Emergency Contraceptive

[Nov 18, 2005]

A Government Accountability Office report released on Monday (November 14) found many "unusual" aspects regarding FDA's 2004 rejection of Barr Laborartories' application to allow nonprescription sales of the emergency contraceptive Plan B, including atypical involvement of senior staff and a "novel" rationale for rejection of the application. FDA in May 2004 issued a "not approvable" letter in response to the application, citing inadequate data on Plan B use among girls under age 16. The decision contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B be sold without a prescription. In addition, the letter was signed only by Steven Galson, then acting director of FDA's Center for Drug Evaluation and Research, and not by members of the FDA review team, as is routine. Galson later acknowledged that he made the decision to reject the application on his own and did not follow the recommendations of his staff. According to the report, high-level officials at FDA told some staff members as early as January 2004 that the agency would reject the application even though the scientific review was not completed until April 2004 (Kaiser Daily Women's Health Policy Report, 11/15). Several newspapers have published editorials and opinion pieces in response to FDA's actions on Plan B. Some of these are summarized below.

Editorials

* Albany Times Union: "Isn't [FDA] supposed to consider only the science behind ... Plan B and whether it is safe and effective?" a Times Union editorial asks, adding that the GAO report suggests politics, and not science, played a large role in the Plan B decision. Plan B raises "moral and political issues," but those questions should be argued by abortion-rights supporters and opponents while FDA should "limit itself to science," the editorial says (Albany Times Union, 11/17).

* Austin American-Statesman: Concerns that Plan B might cause "adolescent promiscuity are not unreasonable"; however, FDA is supposed to be about the "safety of drugs intended for human consumption, not social work or moral politics -- that's what Congress is for," an American-Statesman editorial says. FDA does not admit to "political tinkering" with Barr's application, but GAO's report "strongly suggests that officials ... acted in the name of politics, not science," when rejecting the original application, the editorial says. The agency "should approve the application and keep political considerations out of its drug safety decisions," the editorial concludes (Austin American-Statesman, 11/17).

* Chicago Tribune: The "science is clear" and the evidence "overwhelming" that Plan B is safe, which is "all the FDA needs to know" to grant approval for nonprescription sales of Plan B, according to a Tribune editorial. FDA's role is "not to approve those drugs that are politically palatable but to ensure drugs are safe and effective," the editorial says, adding that the agency needs to "return to that scientific mission and stop playing politics with Plan B" (Chicago Tribune, 11/18).

* Des Moines Register: The U.S. government "is limiting women's control over their own health" by restricting access to Plan B "to please conservative activists," a Register editorial says, adding that the GAO findings should "shame" FDA into approving nonprescription sales of Plan B for women of all ages. The editorial concludes that preventing nonprescription sales is "foolish if the hang-up is how to keep young teens from easy access to the drug. They are, after all, a group that shouldn't be having babies" (Des Moines Register, 11/16).

* Las Vegas Sun: The "far-right conservatives who oppose abortion and who have a stranglehold on the Bush administration" think that Plan B causes abortion and would "promote sexual promiscuity" if sold without a prescription, a Sun editorial says. However, these feelings should not play a role in a "scientific review of a drug's safety and marketing guidelines," the editorial says, concluding that decisions "affecting the public's health ... should be based on scientific reasons rather than political ones" (Las Vegas Sun, 11/18).

* Los Angeles Times: Although "everybody knew it anyway, ... it's worthwhile to have a respected government office" confirm that FDA's decision to reject nonprescription sales of Plan B was atypical, a Times editorial says. There is persuasive evidence about pregnancy prevention to move forward with nonprescription access to Plan B, and while the Bush administration has been "happy to let this issue drag on unresolved," Congress now has "justification to move it forward," the editorial says (Los Angeles Times, 11/17).

* Louisville Courier-Journal: The most "appalling of the findings" of GAO's investigation is FDA's "capitulation to the religious zealots who equate contraception with abortion, and who want to deny women access to either," a Courier-Journal editorial says. Antiabortion groups "dubbed [Plan B] an abortion pill and claimed" that nonprescription sales could promote sex among teens, the editorial says, concluding that, as a result, "safe, effective means to prevent pregnancies and abortions [are] being arbitrarily and improperly withheld from America's women" (Louisville Courier-Journal, 11/16).

* Orlando Sentinel: The GAO report this week "confirms the worst fears" that FDA "bosses played politics" to prevent the approval of nonprescription sales of Plan B, a Sentinel editorial says. "It is unacceptable that politics would influence the approval of a drug" that, according to scientists, is "safe and effective," the editorial says. The rejection of Plan B "does serious damage to the credibility" of the agency, the editorial says, concluding that FDA, "above all other agencies, should pay more attention to public health than politics" (Orlando Sentinel, 11/18).

* Philadelphia Inquirer: It is "clearer than ever" that FDA is "playing politics with birth control" after the GAO report was released, according to an Inquirer editorial. Decisions about drug safety should be based on scientific findings, the editorial says, adding that in the case of Plan B, the agency "appears to have buckled to political pressure." The editorial concludes that this "outcome does not serve the public interest and tarnishes the agency's credibility" (Philadelphia Inquirer, 11/17).

* Pittsburgh Post-Gazette: FDA should name the "outrageous mindset" used in handling Barr's application the "Queen of Hearts Rule, ... from 'Alice in Wonderland,' where the Queen declared, 'Sentence first -- verdict afterward,'" a Post-Gazette editorial says. The agency invoked such a rule "with the jury still out and months more work needed to reach a scientific conclusion" on Plan B, the editorial says, adding that GAO's report confirms the opinion that FDA "allowed politics to trump science" (Pittsburgh Post-Gazette, 11/18).

* Seattle Post-Intelligencer: The GAO report "ought to embarrass the Bush administration into ending its political roadblock" of nonprescription sales of Plan B, a Post-Intelligencer editorial says. "If President Bush lived up to his promises about basing policy on 'sound science,'" EC already would be accessible to women without a prescription, according to the editorial. However, the administration has routinely "ignored clear scientific evidence that nonprescription emergency contraception sales could be safely allowed nationally," the editorial says, adding that regarding EC, the Bush administration "is blowing smoke in the face of women desperate to avoid pregnancy or abortion" (Seattle Post-Intelligencer, 11/16).

* St. Petersburg Times: The issues of pregnancy and abortion have become "[s]o poisonous" that "even emergency contraception now must pass a political test in a federal agency created to examine science," a Times editorial says. FDA's handling of the Plan B decision is "tampering," and it deserves further congressional investigation, the editorial says, adding, "If the FDA is to act merely as a tool for political interests, then the government might as well shut it down and save the money" (St. Petersburg Times, 11/17).

* USA Today: FDA's purpose is not to "choose sides in the nation's culture wars, much less abandon science in favor of agendas that have more to do with religion and morality," a USA Today editorial says, adding that rejecting Barr's original application calls into question what the agency might do in the future. FDA's purpose is not to "police teen sexual behavior, much less enforce religious doctrine," the editorial says, adding that "capitulation to abortion politics betrays [the agency's] history and the nation's values" (USA Today, 11/17).

* Washington Post: The GAO report focused on the "unusual" events leading up to the original rejection of nonprescription sales of Plan B, but Congress now should focus its attention on more recent events involving FDA's recent suspension of another Plan B decision, a Post editorial says. According to the editorial, legislators should work on "unblocking the impasse over this decision, on uncovering the reasons for [former FDA Commissioner Lester] Crawford's resignation, and on getting the administration to explain why it has allowed an enormously important and influential regulatory agency to remain leaderless for so much of its time in office" (Washington Post, 11/18).

Opinion Pieces

* Cindy Richards, Chicago Sun-Times: "It's hard to believe that women in the most advanced country in the world might once again find birth control unavailable," Sun-Times columnist Richards writes in an opinion piece, adding that it is also difficult to fathom that there are antiabortion groups that want that to happen. Preventing unplanned pregnancies is the "best way to prevent abortions," Richards writes, adding, "There simply can't be any debate about that" (Richards, Chicago Sun-Times, 11/16).

* Steve Chapman, Chicago Tribune: "As a longtime pro-lifer, I think antiabortion groups had solid grounds to oppose [Plan B] when its function was unclear," Tribune columnist Chapman writes in an opinion piece, adding that EC is actually a drug that, instead of "produc[ing] abortion, is found to prevent abortion." If EC were available without a prescription, "a lot" of unplanned pregnancies and abortions could be prevented, he writes, concluding, "For anyone who believes in the sanctity of life from the moment of conception, Plan B is not an enemy but an ally" (Chapman, Chicago Tribune, 11/17).

* Wendy Wright, USA Today: "Thankfully, FDA's leadership considered" that making Plan B available without a prescription "would needlessly expose adolescents to risk and reduce access to necessary health care," Wendy Wright, executive vice president of Concerned Women for America, writes in a USA Today opinion piece. In trying to drive sales, advocates "encourage multiple sex partners" without considering that those actions put women at risk of sexually transmitted diseases, Wright writes, adding, "Good public health, science and common sense rule against making Plan B as easy to get as toothpaste" (Wright, USA Today, 11/17).

PBS' "NewsHour with Jim Lehrer" on Wednesday discussed Plan B and the GAO report with health correspondent Susan Dentzer (Brown, "NewsHour with Jim Lehrer," PBS, 11/16). The complete transcript is available online. The complete segment is available online in RealPlayer and Windows Media.

Kaiser Daily Women's Health Policy | Opinion [Nov 18, 2005]

This page last updated March 23, 2008 14:38 .