By Cynthia L. Cooper
Tuesday, November 15, 2005
Political appointees at the FDA--not agency scientists--decided in 2004 that over-the-counter marketing of emergency contraception would not be allowed, a GAO report released yesterday said.
(WOMENSENEWS)--The Government Accountability Office released a blistering 62-page report yesterday, charging that the Food and Drug Administration did not follow its own procedures when it denied women access to the morning-after pill, Plan B, through drugstore sales.
In May 2004, the FDA denied over-the-counter sales of the high-dose birth control pills that can be used after intercourse to prevent pregnancy, despite the recommendations of two scientific advisory panels that it be sold without a prescription. The FDA staff experts concurred.
The GAO investigation indicated that the FDA decision may have been made by Bush administration political appointees at the head of the agency before the experts finished their analyses.
Four FDA division directors reported to the GAO that Mark McClellan, the FDA commissioner at the time, had decided that drugstore sales would be denied.
"They were told by high-level management that the Plan B OTC (over-the-counter) switch application would be denied months before staff had completed their reviews of the application," said the GAO report, prepared by its director of health care, Marcia Crosse.
Crosse reported that higher-level management denied this allegation. McClellan refused to be interviewed, as did Lester Crawford, then the deputy commissioner, who denied involvement with the decision-making process through his lawyer.
"The GAO report is shocking and sad," said U.S. Representative Carolyn Maloney (D-NY) at a press conference in New York shortly after the report was released. "Political appointees, not scientific staff, made the decision to deny Plan B."
In June 2004 Representative Maloney was one of 48 senators and representatives who asked the GAO, an independent government investigative body, to look into the matter.
Senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-Wash.), among those who asked for the GAO investigation, issued a joint statement. "This long-awaited report leaves no question that science was compromised," the statement said. "Despite overwhelming evidence that Plan B is safe and effective, politics trumped science in this case."
The GAO report also found that the FDA deviated substantially from the normal processes used in every one of its 67 prior evaluations for over-the-counter status. The report cites three other unusual aspects: high-level management was more involved in the review than in other cases; responsible staff personnel disagreed with the decision and the rationale was novel and contradictory to FDA practices.
At the time that Barr Laboratories, the distributor of Plan B, applied for over-the-counter sales in April 2003, several groups argued against it. Concerned Women for America, a Washington-based organization devoted to Biblical principles, claimed that easier availability to Plan B would have a negative impact on adolescents who would be more promiscuous if it were available.
The FDA, in declining to make emergency contraception available over-the-counter, said that it was concerned about the impact on adolescents under the age of 16. However, the GAO report notes that this stands in opposition to prior decisions.
"There are no age-related marketing restrictions for any prescription or OTC [over the counter] contraceptives that FDA has approved," the report said.
In addition, the GAO report notes that FDA staff reported that its role is to consider the value and safety of the drug product, not how a patient arrived at the need for a drug.
Since the FDA issued the decision to deny the application for over-the-counter sales, the Center for Reproductive Rights, a New York-based litigation group, filed a lawsuit in federal court in Brooklyn, arguing that the FDA ignored sound science and applied different standards from those applied to other drugs. The FDA has asked that the court reject the claims without further consideration, and a hearing is scheduled for Dec. 20, said lawyer Nan Strauss, a lawyer with the Center for Reproductive Rights.
In July 2004, Barr Laboratories reapplied for over-the-counter status, this time with sales limited to individuals 16 and over.
In late August, 2005, the FDA announced that it was postponing a decision indefinitely on that application, despite promises by Lester Crawford, who was named the FDA Commissioner, that a decision would be issued in September. Soon afterward, a leading women's health expert, Dr. Susan Wood, resigned from the FDA in protest and Crawford announced his retirement later in the month.
Representative Maloney recently introduced legislation requiring the FDA to immediately issue a decision on Plan B's application. Maloney said that she may also seek hearings in Congress on the failure of former FDA Commissioner McClellan to make his correspondence and e-mail available to the GAO, an apparent violation of open records laws.
Plan B is taken within 120 hours after intercourse to prevent a pregnancy and is most effective within 24 hours. Plan B is available in eight states directly from pharmacists.
Pharmacists For Life International opposes emergency contraception and insists that pharmacists should not be required to provide it because they consider it to be the same as an abortion, because it interferes with an egg-sperm union.
Medical doctors say that Plan B is not an abortifacient but stops the establishment of a pregnancy, which occurs approximately eight days after intercourse when a fertilized egg attaches to a woman's uterine wall.
Most recently, women have complained that Target Stores permit pharmacists to refuse to fill emergency contraception prescriptions and Planned Parenthood Federation of America has protested.
FDA approval for direct sales is necessary to make sure women obtain the product quickly and when it is most effective, said Dana Czuczka, director of government relations for Planned Parenthood of New York City.
"Over-the-counter availability would allow more timely use, eliminating barriers such as limitations of physicians' office hours or pharmacists who refuse to fill birth control prescriptions."
The GAO report lays to rest one area of controversy about the role of an evangelical Christian doctor, Dr. W. David Hager.
Hager was one of four on an FDA expert panel with 27 members to vote against wider Plan B sales. He later claimed that he had been asked by the FDA to write a minority opinion and that it was the key to the FDA denial. The GAO report said his letter offered nothing new and did not seem to be written at the behest of the FDA.
Cynthia L. Cooper is an independent journalist in New York with a background as a lawyer and writes frequently about justice and reproductive rights.
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