By Cynthia L. Cooper
Tuesday, February 10, 2004
Easier access to the morning after pill is unlikely to be approved this month by the Food and Drug Administration. Instead, the agency is likely to delay over-the-counter sales.
(WOMENSENEWS)--Whether women may be able to purchase the morning-after pill over-the-counter is expected to be decided by Feb. 20 by a federal regulatory agency. However, the ruling by the Food and Drug Administration could be delayed for weeks and receiving of the actual approval for distribution may even take much longer, say observers of the process.
FDA Commissioner Mark B. McClellan is slotted to make the announcement later this month thatwill determine the nonprescription availability of Plan B, progestin pills that women can take for up to three days after a sexual encounter to prevent the establishment of pregnancy. The FDA did not respond to requests for comment.
Reproductive rights supporters were initially euphoric after two advisory committees met on Dec. 16 and supported direct sales of the pills to women. But developments behind-the-scenes since then indicate that the FDA is not ready to give a stamp of approval. One sign of a pending delay is a standstill on package labeling which runs counter to preparations for approval, according to a former FDA staffer who spoke on condition of anonymity.
The company navigating Plan B through the process and will also market the drug, Barr Laboratories, Inc., is in "constant contact" with the FDA, said spokesperson Carol A. Cox, and "until February 20, nothing is finalized." But she did add that the company will continue to make Plan B available by prescription, even if over-the-counter approval is delayed or denied.
Emergency contraception, as the morning-after pills are known, was declared "safe and effective" by the FDA for pregnancy prevention after sexual intercourse in 1997. Soon after, Plan B and Preven, another emergency contraception pill, were approved for prescription sales. The products are different types of high-dose birth control pills that work, variously, by inhibiting the release of eggs, blocking sperm activity or preventing a fertilized egg from implanting in the uterine wall, which medical authorities denote as the beginning of a pregnancy.
In April 2003, Women's Capital Corporation, which brought Plan B to market, applied for over-the-counter status after studies showed women could self-diagnose their need and follow packet directions. Barr took over the FDA application when it began the still-ongoing process of purchasing Women's Capital Corporation in fall 2003. Ellen Chesler, chair of the Women's Capital Corporation board, told Women's eNews the company is "still hopeful" of success on the application.
Dr. Carole Ben-Maimon, president and chief executive officer of Barr's product development organization, explained to the Nonprescription Drugs and Reproductive Health Drugs Advisory Committee in December that the need for a doctor's prescription makes it impossible for many women to access emergency contraception when they need it--soon after unprotected sex.
"Most of these events are not occurring nine to five, Monday to Friday," she said. "The prescription setting has significant barriers and time delays."
The American Medical Association endorsed the application, and the president-elect of the American College of Obstetricians and Gynecologists called it a "public health imperative." Five states--California, Alaska, New Mexico, Washington and Hawaii--currently permit women to obtain the pills without seeing a doctor by consulting with a specially trained pharmacist; a similar proposal passed the New York State Assembly on Feb. 2.
The committees found unanimously that data showed Plan B is safe for nonprescription use and, with few dissensions, that consumers would use the product as recommended. On a final vote of 23-4, the committees recommended a switch to over-the-counter status. Voting against availability was Dr. W. David Hager of Louisville, whose 2002 appointment to the reproductive drugs committee by President George W. Bush stirred concern because of his reputed opposition to contraception.
"The science presented at the hearing was very clear. But the FDA doesn't have to go along with the advisory committees," said Dr. Beverly Winikoff, president of Gynuity Health Projects in New York City, a nonprofit that works on reproductive health technologies. "The FDA is an independent body. The question is: Is anybody going to interfere with that independence?" said Winikoff. She added: "Anything could happen."
Aside from approval or denial of over-the-counter status, the FDA can issue an "approvable" letter, which would call for the company to meet certain conditions or restrictions. Significant delays could follow if additional field research were required, such as further analysis of teen health impacts or use. The decision itself also can be postponed beyond the Feb. 20 target date, according to governing law.
Since the hearings, conservative organizations have renewed campaigns to stop over-the-counter access. Forty-nine conservative members of Congress, led by Rep. Dave Weldon, a Republican from Florida, wrote to President Bush in mid-January, saying that over-the-counter availability would lead to teen promiscuity. Dr. Gene Rudd, associate executive director of the Tennessee-based Christian Medical Association, released a statement declaring that greater access will encourage "high-risk sexual behavior."
Alerts issued by the Concerned Women for America, Washington, D.C., called for rejection of over-the-counter status and, in an FDA submission, the conservative women's organization demanded that the original prescription approval be rescinded as well. The American Life League, based in Virginia, along with the Family Research Council in Washington, D.C., and other groups opposed to abortion declared that emergency contraception, by preventing implantation of a sperm-egg union, causes abortion. (Plan B is unrelated to a pill used for abortion, RU-486 or mifepristone.)
Supporters of the greater access for Plan B responded. U.S. Rep. Carolyn Maloney, a New York Democrat, and 75 members of Congress wrote the FDA on Jan. 30, urging that it heed the recommendation of the advisory committees. The pills, they wrote, "do not cause abortion and do not work if a woman is already pregnant."
Last week, after meeting with Barr representatives, the Reproductive Health Technology Project in Washington D.C., the leading advocacy group for emergency contraception, sent out a memo, urging supporters to contact the FDA once again.
"Rumors are now circulating that political pressure may override the scientific basis of this issue," the memo said.
At least one group is already in gear. New York State and Gainesville, Fla., chapters of the National Organization for Women are circulating petitions that ask women to promise civil disobedience by providing prescription pills to needy friends if approval is denied.
"Having morning-after pills at their fingertips could change so many things for women. It's another way women can control whether they want to have a child and that's a cornerstone of freedom," said Erin Mahoney, co-chair of the New York reproductive rights task force. The group is planning a post-Valentine's speak-out in New York City on Feb. 15.
Cynthia L. Cooper, a freelance writer with a background as a lawyer, reports frequently on reproductive rights and justice topics.
Reproductive Health Technologies Project--
Emergency Contraception: Overview:
New York State National Organization for Women--
Urge FDA Commissioner to Approve Over-the-Counter Sale of the