FDA bars over counter morning-after pill

  1. This article in the 5/7/2004 Times Union caught my eye!

    Unbelievable. . . .


    FDA bars over counter morning-after pill

    By LAURAN NEERGAARD, Associated Press
    Last updated: 2:31 a.m., Friday, May 7, 2004

    WASHINGTON -- Women's groups are accusing the Bush administration of putting politics before science in rejecting over-the-counter sales of morning-after birth control, even though regulators left open the possibility they will reconsider.

    The Food and Drug Administration cited concern about young teenagers' use of the pills in rejecting the move Thursday.

    The decision overruled a recommendation from FDA's own scientific advisers, who had overwhelmingly called easier access to emergency contraception a safe way to prevent thousands of abortions.

    A disappointed Barr Laboratories, maker of the Plan B emergency contraception brand, plans to rapidly seek nonprescription sales approval again -- at least to people age 16 and older.

    "It's a matter of weeks and months to deal with this objection," said Barr chief executive Bruce Downey, saying that means the FDA could reconsider the issue within a year. "Clearly ... the door's open, and we plan to go through it."

    The FDA complained that Barr provided no evidence that teens under 16 could use the pills appropriately without a doctor's guidance. Warned in February of that concern, Barr offered a last-minute proposal to allow nonprescription sales to anyone 16 and older -- and make drugstores check ages and demand a prescription from younger teens.

    But the FDA said the company didn't provide necessary details on how such a program, never before tried, would work. It said, though, it would reconsider if Barr provided more details and teen data.

    "Wide availability of safe and effective contraceptives is important to public health," FDA acting drug chief Dr. Steven Galson wrote the company. "We look forward to continuing to work with you if you decide to pursue either of these options."

    The morning-after pill is a higher dose of regular hormonal contraception. Taken within 72 hours of unprotected intercourse, it can cut a woman's chances of pregnancy by up to 89 percent. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays.

    Contraceptive advocates and doctors' groups say easier access could reduce by half the nation's 3 million unintended pregnancies each year. In December, FDA's scientific panel agreed, voting 23-4 that nonprescription sales would be a safe and important way to prevent abortions.

    Afterward, the FDA came under months of intense political pressure from conservatives who argued that unfettered access could encourage more teen sex.

    Women's groups charged Thursday that the agency cracked.

    "The decision blatantly disregards the overwhelming scientific evidence," said Kirsten Moore of the Reproductive Health Technologies Project. "The Bush administration has denied American women timely access to a safe, proven second chance to prevent pregnancy."

    "The White House is putting its own political interests ahead of sound medical policies that have broad support," said a spokesman for Democratic presidential candidate John Kerry.

    The FDA's move will "have a negative impact on the public health," said Dr. Alastair Wood of Vanderbilt University, one of FDA's scientific advisers who noted that many other countries allow nonprescription sales.

    But conservatives welcomed the decision.

    "The FDA is siding with our nation's teens and their health," said Rep. Dave Weldon, R-Fla., himself a doctor.

    "The FDA is right to be cautious about having a potent drug that can harm women next to candy bars and toothpaste," said Wendy Wright of Concerned Women for America, a group that opposes abortion.

    Within the FDA, the decision was mixed. An internal agency memo, obtained by The Associated Press, suggests medical reviewers backed nonprescription sales but were overruled by senior officials.

    "Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity," said Galson's memo. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."

    Galson wrote that "despite the urgent need to prevent pregnancy" among 11- to 14-year-olds, Barr provided no data on how younger teens would use the nonprescription pills.

    Studies on college campuses show a decline in pregnancy and abortion with wider availability of the morning-after pill.

    To improve access, five states -- California, Washington, Alaska, Hawaii and New Mexico -- already allow women to buy morning-after pills from certain pharmacists without a prescription. The FDA's decision does not affect those programs.

    If a woman already is pregnant, morning-after pills have no effect.
  2. 11 Comments

  3. by   fergus51
    I think it's a real shame. We talk about wanting to prevent the number of abortions in this country, but won't allow the morning after pill.... It is no different than birth control pills. I don't understand the argument for not allowing it.
  4. by   Ted
    Quote from fergus51
    I think it's a real shame. We talk about wanting to prevent the number of abortions in this country, but won't allow the morning after pill.... It is no different than birth control pills. I don't understand the argument for not allowing it.
    It's a religious/political arguement against it. Can't get into it any further without my blood pressure rising. Blech!!

  5. by   Jaaaman
    There are many reasons to oppose the morning after pill, including health and safety reasons as well as the fact that it sometimes acts as an abortifacient by preventing implantation. Many women would refuse to use the pill if this fact were made clear to them. Pharmacists should be given the right to refuse to sell it if their consciences object.

    In the United Kingdom, the morning after pill is sold pharmacist-direct. Post-marketing surveillance there found a significant increase in the rate of ectopic pregnancies (6% as opposed to the usual rate of 2% or less). This is a serious health risk when young adolescents will have unsupervised access to the morning after pill if it is sold over-the-counter.

    The most powerful arguments in favor of the morning after pill are claims that its use will prevent 50% or more of unintended pregnancies and thereby reduce the abortion rate.

    This is not true as can be easily proven. In Sweden, where the morning after pill has been available over the counter since the late 1990s, teenage abortion rates have gone up from 17/1000 to 22.5/1000. In Washington State, the morning after pill has been available pharmacist-direct since 1998. Abortion rates there have not been cut in half. They are gently trending downward; however, the decrease coincides precisely with the nationwide decrease in abortion rates.

    A study by Michael New proved that one of the major reasons for the reduction in abortions in the last few years has been the various laws restricting access to abortion enacted by various states (parental consent, waiting periods, etc.)

    Finally, rates of Sexually Transmitted Diseases are skyrocketing wherever the morning after pill has been made available (Sweden and Washington State, for example).

    Based upon experience of various states and countries already selling the morning after pill either pharmacist-direct or over-the-counter, it is most likely that if the morning after pill is made available over the counter in the U.S., there will be no reduction in unplanned pregnancies, a skyrocketing increase in STDs (especially among youth), and possible serious health risks which have not yet been studied, especially among adolescents.

    This is a public health disaster of historic proportions in the making.

    A complete research report on this issue has been published at Population Research Institute called "Under the Table."

    www.pop.org under 'Indepth Reports.'"
  6. by   Energizer Bunny
    Well, I'm all for the morning after pill, except I really think that it will be abused by those that don't want to use condoms...oops, no condom..guess I'll just go pick up Plan B! There is no way to prevent that from happening and I think it's a shame. We very well may see a rise in STD's and AIDS if that happened. Just some random thoughts that fly through my head.
  7. by   tnrn2be
    It saddens me the direction our country has went in the last few years. I have a 12 year old daughter and a 6 year old son and the thought of their adolescent years terrifies me. I was unwed and pregnant at 17. I never considered abortion or adoption. I realized I had made my bed and now I had to lay in it ....I grew up overnight. Unfortunately, not all teen mothers and fathers accept the responsibility of their actions. I think alot of the reason I handled everything so well was my very supportive family. Don't get me wrong, I did not have the perfect family---my parents had divorced the year I got pregnant, but they were both there for me. The though of abortion as a form of birth control disgusts me. I am also against the morning after pill. Personally, I don't want my kids having sex and thinking "the morning after pill is there just in case". I think it will give people a false sense of security and STD's will run rampant. I don't think people realize the seriousness of STD's and have the "it won't happen to me mentality". I hope I have instilled the morals and values in my children so they will not make the choices I did. If not, we'll deal with whatever happens then.
  8. by   Nurse Ratched
    We discussed this on another thread when the FDA was considering it. While I am all for women having control over their reproductive selves, I am concerned about this being readily available to a general population that can't even understand taking a full course of antibiotics.

    It is just like BCP - and those are by prescription only, and for good reason. We have a screening area with standing orders for dispensing of EC after our nurse reviews some information and makes sure the person is an appropriate candidate for it. I like there being a little bit of oversight.

    However, I'm not sure that this is the reasoning that the administration is actually using.
  9. by   fergus51
    I like how whenever something good happens after this med is available OTC (like decreasing abortion rates) it has nothing to do with the med being available. But, when something bad happens (increasing STDs) it is all because this med is available. Those same arguments were all used in favor of banning birth control pills. I for one didn't become a promiscuous disease spreading abortionner when I started using contraception.

    Some people consider it an abortion inducing med, but by that definition so are BCPs. If some pharmacies don't want to sell it, I could care less. But to deny it to people because some of us personally don't like it seems selfish and paternalistic to me. It's the same old argument (women aren't intelligent enough to be able to use a medication properly, so we'll just protect them cause we know best).
  10. by   Hellllllo Nurse
    I don't believe people will change their behaviors based on whether or not the "Morning After" pill is available, otc or otherwise.

    Most teenagers who get pregnant aren't thinking enough for that.

    The same arguments against the MA pill are the same arguments that were raised against The Birth Control Pill when it was first introduced.

    Same arguments are used against needle exchange programs, free comdoms to minors programs, sex-education programs, etc.

    Many conservatives will argue against any and every idea that provides people with the knowledge and tools needed to prevent unwanted pregnancy, STDs, HIV, etc.,

    The only approach they approve of is the completely ineffective, totally impotent "Just Say No".

    Well, the "Just Say No" approach is a total and resounding failure.
  11. by   Jaaaman
    It has not worked : abortion

    There can be no doubt that contraception can be easily obtained and that the quantity and explicitness of sex education has dramatically increased over the past 25 years.

    Despite all this, and the provision of the morning after pill which was first licensed and manufactured in 1985, the teenage abortion rates are much higher now than they were 25 years ago.

    The percentage of all pregnancies terminated by abortion has increased every year since 1993.

    It has not worked : STDs

    The Department of Health have admitted that the UK is in a state of "poor sexual health" :

    "Virtually all the sexually transmitted infections (STIs) are increasing. The number of attendances at departments of genitourinary medicine/sexually transmitted diseases now totals 1 million per year, a doubling over the last decade. The commonest conditions are genital warts (some types of which can be associated with the subsequent development of carcinoma of the cervix), chlamydia and gonorrhoea, which if untreated can result in ectopic pregnancy and infertility. Chlamydial infection seen in clinics has risen by 21% between 1996 and 1997, and a further 13% from 1997 to 1998 (latest figures). Population surveys have reported rates of chlamydia as high as 20%, particularly in young women.
    There has been no reduction in the annual number of new diagnoses of HIV made and the latest annual figures (1999) saw the highest number of new HIV diagnoses ever recorded."

    The myth of safe sex

    In the 1980s much was said about 'safe sex', that is, sex using a condom. In the 1990s the term was changed to 'safer sex'. This change protected condom manufacturers from litigation, but the distinction will be lost on young people. 'Safer sex' materials rarely tell young people of the typical condom failure rate.

    Medical journals report condoms having a typical failure rate of 14%. This means that with typical use 14% of women will become pregnant over the course of a year. This is much higher than the often quoted 'perfect use' rate of 2% of women per year.

    It is common sense to expect that the failure rate amongst teenagers will be higher. One family planning clinic in Manchester found that 52% of those who obtained a condom from the clinic had one or more either burst or slip off in the previous three months.

    A failure rate for pregnancy will always be lower than the failure rate for sexually transmitted diseases since women have 23 non-fertile days where condom failure does not result in pregnancy.

    Condom failure can result in infection by an STD on any day of the month.

    Promoting promiscuity

    Given all the objective facts about the rates of teenage pregnancies, abortions and STD infections, it is reasonable to question whether the present policy of safer sex is in fact achieving the many claims made for it.

    The sex education establishment which has promoted safer-sex is the same establishment now promoting the use of the morning after pill.

    The availability of the morning after pill further fosters the belief amongst girls that they can have sex without consequences. Unlike the regular contraceptive pill, they do not have to take one every day. Unlike the condom neither they nor their sexual partner have to remember to take one with them. Nor is there the problem of persuading their sexual partner to use one.

    For all these reasons the morning after pill is an easy alternative to condoms. That is why use of the MAP is linked to reduced use of condoms.

    If the Government goes ahead with all its morning after pill schemes the message will not be lost on young people. Everyone from GPs to health authorities, school nurses to headteachers, from youth workers to the Prime Minister will be going out of their way to make the morning after pill available to them.

    It gives the green light to sleeping around. A message which will probably have a much more powerful impact in the statistics than the drug itself.

    The journalist Jeannette Kupfermann commented :
    'An over-the-counter sale will do nothing to address the underlying behaviour that leads to the woman needing emergency contraception in the first place. It gives her permission to continue in the same old irresponsible way.'
    Last edit by Jaaaman on May 7, '04
  12. by   donmurray
    This scaremongering opinion piece dates from January 2001. Is there nothing more recent?

    ps The sky hasn't fallen here yet!
  13. by   Hellllllo Nurse
    Saying that The Morning After Pill gives teens "the greenlight to sleep around" is akin to saying that seatbelts give drivers the green light to drive recklessly.