Daily Women's Health Poicy Recent Reports

FDA Scientists Disagreed With Agency's Reasons for Rejecting OTC Status for EC Plan B, Internal Documents Show

[Jun 18, 2004]

FDA scientists "dismissed" the agency's reasoning for its rejection of over-the-counter status for the emergency contraceptive Plan B, according to internal agency documents, the Washington Post reports (Kaufman, Washington Post, 6/18). FDA in May issued a "not approvable" letter to Barr Laboratories -- the manufacturer of Plan B -- citing inadequate data on the use of the pills among girls under age 16. The agency's decision was unusual because it contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B be sold without a doctor's prescription. In addition, Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said he made the decision to reject the application on his own and did not follow the recommendations of his staff (Kaiser Daily Reproductive Health Report, 6/9). FDA scientists disagreed particularly with the agency's finding that there was not enough information on how Plan B would affect the sexual behavior of younger women, according to the Post (Washington Post, 6/18).

Memo Details
Dr. John Jenkins, director of FDA's Office of New Drugs, wrote in internal memos that Plan B did not pose any particular risks for younger women and that the agency was subjecting Barr's application to more rigorous examination than applications for other drugs, the Wall Street Journal reports. He added that Barr's application was "fully consistent with the agency's usual standards for meeting the criteria" for OTC status, saying that the key criteria for approving the application should be the evidence that the pills can be used safely and effectively without a doctor's supervision. Jenkins also said that FDA never before had considered young women's use of oral contraceptives to be problematic (Wall Street Journal, 6/18). Jonca Bull, head of the FDA office that oversees decisions to make drugs available without prescription, wrote in internal memos that the concerns regarding OTC status for Plan B were "speculative and unbalanced." Bull added that because FDA had approved numerous other contraceptive products for OTC status, a precedent existed for Plan B -- which can significantly reduce the risk of pregnancy if taken within 72 hours of sexual intercourse -- to be sold without a doctor's prescription. FDA spokesperson Lawrence Banchorik said that FDA "will not comment on internal deliberative documents that were part of our decision-making process," according to the Post (Washington Post, 6/18).

Greenwood Comments
Rep. Jim Greenwood (R-Pa.), who met with Galson earlier this month, last week said he expected FDA to reverse its decision on Barr's application for Plan B and approve OTC status for the pills for women ages 16 and older (Kaiser Daily Reproductive Health Report, 6/9). Greenwood, who called FDA's decision a "horrible one," said he was surprised when Galson indicated that he was considering approving OTC status for Plan B within six months. "There was no guarantee from Galson, but he said their only concerns were for girls under 16, and I took that to mean they would approve it OTC for everyone else quite soon," Greenwood said. When asked if he thought FDA's initial rejection of Barr's application was influenced by politics, Greenwood said, "[M]aybe some folks thought it would be more comfortable politically to give an approval after the election," adding that he had no direct information on any political links (Washington Post, 6/18).

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In The Courts

Kentucky Supreme Court Rules State Homicide Law Applies to 'Viable' Fetuses; Legal Abortion Exempted

[Jun 18, 2004]

The Kentucky Supreme Court on Thursday ruled that a "viable" fetus is a person and that the state's homicide and manslaughter laws apply to such fetuses, the Louisville Courier-Journal reports. The ruling, which does not apply to legal abortions, overturns a 1983 state Supreme Court decision that said homicide and manslaughter charges only could apply to infants who were born alive and not to fetuses, according to the Courier-Journal (Gerth, Louisville Courier-Journal, 6/18). Justice William Cooper, who wrote the decision for the majority, said that medical science now can determine the point of fetal viability -- when a fetus would be able to survive outside of the uterus -- adding, "Thus the rationale for the 'born alive' rule no longer exists," according to the AP/Courier Journal (Wolfe, AP/Louisville Courier-Journal, 6/17). The court did not define viability, saying that viability would have to be "proven by competent evidence" in court in individual cases, according to the Lexington Herald-Leader (Cheves, Lexington Herald-Leader, 6/18). The ruling does not apply retroactively and does not determine the constitutionality of the state's new fetal homicide law, according to the Courier-Journal (Louisville Courier-Journal, 6/18). The fetal homicide law (HB 108) allows the state to charge an individual with a separate crime for terminating a fetus during the commission of an act that injures or kills a pregnant woman. The measure applies to fetuses at any gestation but does not define a fetus as a person. Under the measure, individuals convicted of fetal homicide could be sentenced to life in prison without parole (Kaiser Daily Reproductive Health Report, 2/20).

Separate Opinions
In a separate opinion, Justices James Keller and Janet Stumbo criticized the majority opinion for creating an "evolving notion" of what defines a "person" under the state's homicide and manslaughter laws, the Herald-Leader reports. Keller and Stumbo wrote that the state Legislature has changed the homicide laws several times since the 1983 decision but has never given a clearer definition of a person or suggested that the born-alive standard was wrong, according to the Herald Leader. "The fact that the fetal homicide legislation was enacted at all cements my conclusion that criminal homicide liability" was not available for killing a fetus, Keller and Stumbo wrote. Justice Donald Wintersheimer wrote in a third opinion that the majority had not gone far enough to expand the definition of "person," according to the Herald-Leader. Wintersheimer wrote, "Medical authority has long recognized that an unborn child is in existence from the moment of conception," adding, "For any purpose other than abortion, many jurisdictions have abandoned viability because it has no magic sense in identifying the beginning of a person's life" (Lexington Herald-Leader, 6/18).

Reaction
Robert Cetrulo, an attorney for Northern Kentucky Right to Life, which filed briefs in the case, said that the decision is a "step in the right direction," adding, "We're headed toward a re-examination of when life begins under all parts of the law" (Lexington Herald-Leader, 6/18). Jay Wethington, a Daviess County attorney, said that the ruling was a "great decision for the right reason," according to the Owensboro Messenger-Inquirer. However, Wethington said that viability will have to be established by case precedent, making the definition of a person "quite blurry." He added that the decision could be viewed as an attack on the U.S. Supreme Court's Roe v. Wade decision, which struck down state bans on abortion (Owensboro Messenger-Inquirer, 6/18).

Case
The state Supreme Court's ruling came in the case of Christopher Morris, who was charged and convited of two counts of manslaughter in the death of Veronica Thornsbury and her fetus in a March 2001 car accident, the Courier-Journal reports (Louisville Courier-Journal, 6/18). A three-judge panel of the Kentucky Court of Appeals in September 2002 ruled that the state could not charge him with a separate count of manslaughter for the death of the fetus because of the lack of a firm legal basis for determining life based on whether a fetus could survive outside a woman's uterus (Kaiser Daily Reproductive Health Report, 9/16/02). Despite Thursday's state Supreme Court ruling, Morris' second manslaughter conviction will not be reinstated because the ruling is not retroactive. Morris currently is serving a 10-year prison sentence for the death of Thornsbury, according to the Courier-Journal (Louisville Courier-Journal, 6/18).

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State Politics & Policy

Illinois Lawmakers Rename Proposed Stem Cell Research Act in Memory of Former President Reagan

[Jun 18, 2004]

Illinois state Sen. Jeffrey Schoenberg (D) and state House Minority Leader Tom Cross (R) on Wednesday joined with health advocates to rename the proposed Stem Cell Research Act (HB 3589) in memory of former President Reagan, who died on June 5 from Alzheimer's disease, the Chicago Sun-Times reports. Former first lady Nancy Reagan has voiced her support for human embryonic stem cell research, which proponents say could lead to treatments or cures for diseases such as cancer, juvenile diabetes and Alzheimer's (Ritter, Chicago Sun-Times, 6/17). The bill, which specifically permits embryonic stem cell research in Illinois and establishes review of the research by the Illinois Department of Public Health, now will be known as the Ronald Reagan Biomedical Research Act. Schoenberg -- who is the chief sponsor of the legislation -- said, "I was inspired by Nancy Reagan's heartfelt and compelling call for embryonic stem cell research and the agony that both she and former President Reagan faced with his disease." He added, "Since this bill passed the House last spring, we have made real progress towards helping researchers find cures to many serious diseases and conditions. Illinois is home to premier medical research institutions and it pains me to export talented researchers and millions of dollars in funding to other states and countries." Cross added, "We need to put partisan politics aside and focus on the real help we can bring to people all over Illinois. In the spirit of former President Reagan, I urge my colleagues to pass this critical legislation -- legislation that could save millions of lives" (Schoenberg release, 6/16).

Next Steps, Reaction
The bill, which the state House approved 60-56 in March 2003, fell two votes short of being approved last month in the state Senate, where it is still pending, the Sun-Times reports. Sponsors of the measure hope that by changing its name, the measure may gain the few additional votes needed for it to pass. However, state Sen. Peter Roskam (R), who opposes the measure, said that the name change is just a "gimmick" that is unlikely to change anyone's vote, especially in an election year, the Sun-Times reports (Chicago Sun-Times, 6/17).

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Massachusetts Senate Approves Bill To Allow Emergency Contraception To Be Sold Without Prescription

[Jun 18, 2004]

The Massachusetts Senate on Wednesday approved a bill that would allow emergency contraception to be sold without a prescription and would require emergency departments to make EC available to rape survivors, the Boston Globe reports (Castelli, Boston Globe, 6/17). The measure would allow trained pharmacists to dispense EC -- which can prevent pregnancy if taken within 72 hours of sexual intercourse -- without a doctor's prescription on a case-by-case basis, according to the Boston Herald (Wedge, Boston Herald, 6/17). State Sen. Linda Melconian (D) said that the bill's passage is "a necessary step in providing comprehensive contraceptive treatment for women" in Massachusetts, adding, "If one woman is denied access to EC after surviving the horrific effects of rape, we have failed to protect our citizens." NARAL Pro-Choice Massachusetts Executive Director Melissa Kogut said that the measure will "decrease the number of unwanted pregnancies" (Boston Globe, 6/17). However, some abortion-rights opponents believe that EC is a form of abortion, according to the AP/Boston Globe. Catholic Action League Executive Director C.J. Doyle said, "They are forcing Catholic hospitals to dispense contraceptives, which is contrary to natural law and unequivocally condemned by the Catholic religion" (AP/Boston Globe, 6/16). The bill now goes to the state House for consideration. Gov. Mitt Romney's (R) office would not comment on the measure, according to the Globe (Boston Globe, 6/17).

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Contraception & Family Planning

Doctors May Be Able To Predict Timing of Menopause Based on Size of Woman's Ovaries, Study Says

[Jun 18, 2004]

The size of a woman's ovaries may help to predict when she will undergo menopause, according to a study published in the June 17 issue of the journal Human Reproduction, Reuters Health reports (Reuters Health, 6/17). Although most women go through menopause around age 50, it can happen as early as age 42 and as late as age 58 in some women, according to BBC News (BBC News, 6/17). The human ovary is thought to have a limited number of immature eggs that declines throughout a woman's life, London's Telegraph reports. When the number of eggs falls to 25,000 -- usually around the age of 37 -- the decline "accelerates and over the next few years women find it more difficult to conceive," according to the Telegraph. When about 1,000 immature eggs remain in a woman's ovary, she will begin to experience the first stages of menopause (Derbyshire, Telegraph, 6/17). Researchers from the University of Edinburgh in Scotland created a model estimating the average size of a woman's ovaries throughout her reproductive life, and they say that using the model could allow doctors to predict whether a woman will have early- or late-onset menopause (BBC News, 6/17).

Method, Findings
Researchers used data on age-related ovarian volume measured by sonograms to obtain a link between the number of follicles and ovarian volume. Researchers then were able to demonstrate that ovarian volume in women ages 25 to 51 accurately reflects the number of immature eggs remaining in their ovaries (Wallace/Kelsey, Human Reproduction, 6/17). Researchers determined that by using the model, they could accurately predict the timing of menopause, Reuters Health reports (Reuters Health, 6/17). The researchers concluded that determining a woman's immature egg reserve could "revolutionize" the management of women seeking assisted reproductive technologies to aid in conception, women who received cancer treatment as children and women who postpone childbearing for personal or work-related reasons (Human Reproduction, 6/17). Study co-author Dr. Hamish Wallace said, "The age of menopause varies from woman to woman, and there is currently no reliable test of ovarian reserve for an individual woman that will predict accurately her remaining reproductive lifespan" (Reuters Health, 6/17). He added, "In essence, [the study findings] mea[n] we now have the potential to be able to tell a woman how fast her biological clock is ticking and how much time she has before it will run down" (BBC News, 6/17).

CBS' "Early Show" on Thursday included an interview with Dr. Owen Davis, a fertility specialist at Weill Medical College of Cornell University, about the model ("Early Show," CBS, 6/17). The complete segment is available online in RealPlayer. The complete transcript of the segment also is available online.

CBS' "Evening News" on Thursday also reported on the newly developed model. The segment includes comments from Davis and study co-author Tom Kelsey, a computer scientist (Kaledin, "Evening News," CBS, 6/17). The complete segment is available online in RealPlayer.

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