The Religious Consultation
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New York Times, August 27, 2005 U.S. Again Delays Decision on Sale of Next-Day Pill By GARDINER HARRIS WASHINGTON, Aug. 26 - Federal drug regulators on Friday once again delayed making a decision on allowing over-the-counter sales of the morning-after pill, saying they needed more time to gather public reaction to the plan and to figure out how they could enforce it. The announcement infuriated Democrats and abortion rights advocates, who said the Food and Drug Administration allowed politics to trump science. Abortion opponents, however, said the application should be rejected. Lester M. Crawford, the commissioner of food and drugs, said in a news conference that his agency had decided that the science supported giving over-the-counter access of the drug to women 17 and older, but that the agency could not figure out how to do that from regulatory and practical standpoints without younger teenagers' obtaining the pills, too. The application "presented us with many difficult and novel policy and regulatory issues," Dr. Crawford said. The agency will open a 60-day comment period for advice, but the commissioner would not predict when the agency might make a final decision. The pill, called Plan B, is manufactured by Barr Laboratories. In May 2004, the agency rejected a Barr application to sell Plan B over the counter without restrictions, saying the company's studies did not include enough girls younger than 16. Barr reapplied in July 2004, proposing to sell the drug over the counter only to women 16 and older and provide it by prescription to those younger than 16. The agency has never allowed a drug to be sold simultaneously over the counter and by prescription with the same label and strength, Dr. Crawford said. More important, he added, the agency could not figure out how to enforce the age restrictions. "F.D.A. cannot have an inspector in every pharmacy in the U.S.," he said. The delay infuriated Senators Hillary Rodham Clinton of New York and Patty Murray of Washington, both Democrats, who had allowed the Senate to vote last month on Dr. Crawford's nomination as commissioner only after the health and human services secretary, Michael O. Leavitt, promised that the agency would decide on Plan B by Sept. 1. "They broke their promise to Senator Murray and me, to the Congress and to the American people," said Mrs. Clinton, who described the decision as "outrageous," "disturbing" and "a wake-up call to everybody in this country." Ms. Murray said, "A delay is not a decision." The two women said they would demand hearings into the question. Senator Michael B. Enzi, the Wyoming Republican who is chairman of the Senate Health, Education Labor and Pensions Committee, could not be reached for comment, a spokesman said. The chairman and chief executive of Barr, Bruce L. Downey, said he was frustrated that the agency had not made its announcement months ago. The agency was required by its rules to decide on the application in January. "This decision could have been reached much earlier, and we could have been well into the proceeding that they're now just starting," Mr. Downey said. The decision is by far the most politically contentious that agency has confronted in a decade. Whether to provide easier access to the pill has become a pivot point in the debate on abortion rights. Some conservatives say the pill, viewed by the drug agency as a contraceptive, is really an abortion pill. Liberals respond that easier access to it would actually reduce the 800,000 abortions a year in the United States. Seven states allow some over-the-counter access to morning-after pills. But the governors of Massachusetts and New York, both Republicans, recently vetoed bills to ease access in those states. The vetoes were widely seen as efforts by Govs. Mitt Romney and George E. Pataki, moderate Republicans from liberal states, to burnish their conservative credentials ahead of possible presidential campaigns in 2008. Some pharmacists have refused on religious grounds to dispense the pill, prompting Gov. Rod R. Blagojevich of Illinois, a Democrat, to issue an order requiring pharmacists to provide the medicine. The delay on a decision spares pharmacists and major retailers what would have been a very difficult decision about putting the drug on publicly accessible shelves. Carmen A. Catizone, executive director of the National Association of the Boards of Pharmacy, said shelving the pills might create "a real problem" for pharmacists because some customers might object. Karen Pearl, interim president of the Planned Parenthood Federation of America, which provides many abortions, said, "I think they did this because the F.D.A. has chosen politics over legitimate science." Wendy Wright of the Concerned Women of America, a conservative organization, said that the drug agency had "withstood intense political pressure and misinformation." "It's naïve to assume that any age-restriction scheme would be effective," Ms. Wright said. The agency approved Plan B as a prescription contraceptive in July 1999. The pill provides a concentrated dose of the medicines available in most daily birth control pills. It can prevent pregnancy if taken within 72 hours after sex, the agency said. An agency advisory committee voted, 23 to 4, in December 2003 to approve the Barr application to sell the drug over the counter. Staff members at the agency also said the application should be approved. But the director of the agency's drug center, Dr. Steven Galson, announced in May 2004 that he had decided to override the advisory committee and the staff members and reject the application. Dr. Galson said he feared that girls younger than 16 might engage in riskier sex if they knew that the morning-after pill was easily available. He noted that the study of 430 women by Barr on whether patients understood the drug's label had included very few girls younger than 16. Barr then had to make a decision. It could have sponsored a study of young teenagers to prove that they understood how to take the drug correctly or it could apply to sell the drug over the counter only to women older than 16, the option it chose. Barr noted that the agency had already approved over-the-counter sales of nicotine gum only to people older than 18 and that cigarettes and alcohol were routinely sold with age restrictions. Mr. Downey said he had no regrets about that decision. "It was a practical decision to benefit the most women in the shortest period of time," he said. "As it turned out, it didn't work out that way." Dr. Carole Ben-Maimon, head of the Barr proprietary research group, said the agency never told the company how it could set up a study that would satisfy the objections. Besides label understanding, the agency voiced concerns about effects on sexual promiscuity and sexually transmitted diseases. "It's very difficult to figure out a study that would answer all those questions," Dr. Ben-Maimon said. In his announcement on Friday, Dr. Crawford said the drug center had found that Plan B could be safely sold over the counter to women 17 and older. "The criterion in terms of the age limitation has always been is the target population able to interpret the instructions?" Dr. Crawford said. "It's not physiological. Any postpubertal woman would be eligible to use this on prescription basis. The question is at what age do they have the ability to interpret the instructions?" The label study had included 20 16-year-olds and 28 17-year-olds, and there was no discernible difference in their level of understanding, the company said. Dr. Ben-Maimon said she could not explain the decision to raise the age limit by a year. Dr. Alastair Wood, who was on the advisory committee
that approved the original application, said
the F.D.A. "had allowed politics to trump
science."
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