Perspective
The Politics of Emergency Contraception
N Engl J Med 2012; 366:101-102January 12, 2012
Comments
open through January 18, 2012
- Article
On December 7, 2011, Health and Human Services (HHS) Secretary Kathleen Sebelius instructed Food and Drug Administration (FDA) Commissioner Margaret Hamburg not to approve the application for over-the-counter sales of Plan B One-Step, a single-dose emergency contraceptive.1 Dr. Hamburg issued her own public statement2 in which she made it clear that she had intended to approve the application. This is the first time that an HHS secretary has publicly overruled an FDA regulatory decision of this nature, and Sebelius's action has drawn extraordinary attention.
First, the facts: Plan B One-Step, a single 1.5-mg tablet of the progestin levonorgestrel, is intended to be taken as soon as possible after unprotected intercourse. The single dose is at least as efficacious as a previous version of the product, which contained two 0.75-mg tablets of levonorgestrel to be taken 12 hours apart. Levonorgestrel has been widely and safely used as a constituent of numerous oral contraceptives for many years, both as the single levorotatory enantiomer and in the racemic mixture (norgestrel). The best available evidence indicates that it prevents pregnancy largely by delaying or preventing ovulation, but prevention of implantation cannot be ruled out. Levonorgestrel does not cause abortion; it does not terminate an established pregnancy (an implanted conceptus) and should not be confused with the abortifacient mifepristone (RU-486).
Levonorgestrel as an emergency contraceptive has been available in the United States by prescription since 1999, and its safety and efficacy have been well documented and scientifically reviewed. In addition, the safety and efficacy of its use when sold without a prescription (over the counter [OTC]) have also undergone extensive review. The first review was conducted by the FDA and included a public review in a joint meeting of the FDA Advisory Committees for Reproductive Health Drugs and Nonprescription Drugs (in which two of us participated) in December 2003. That meeting resulted in an unequivocal recommendation for approval of OTC status with no age restriction for purchasers. That recommendation was mangled in the regulatory gears of the FDA when the agency did not comply with its own rules and act on the committee's recommendation within 90 days.
In September 2005, the FDA announced yet another delay in making a decision about the fate of OTC status for Plan B. At that time, we called attention to the damage that the FDA was doing — both to its reputation as an impartial regulatory agency that made decisions on the basis of science, insulated from politics, and potentially to women's health.3
After a complicated series of regulatory and political steps, Plan B was finally given “behind the counter” status in August 2006. This action allowed it to be sold without a prescription to women 17 years of age or older with proof of age but required a prescription for those 16 or younger. This status has remained in place since 2006, when the manufacturer of Plan B One-Step applied for approval to make the single-dose treatment available as an unrestricted OTC product. The review was handled by the FDA's internal professional staff. After another detailed review, the staff again recommended Plan B for OTC sale with no age restrictions. Thus, many experts have participated in two separate reviews and have agreed that this drug can safely be used by women to prevent pregnancy without medical supervision — the essential criterion for an OTC approval.
In her letter to the FDA commissioner, Secretary Sebelius stated that, “Based on my review, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.”1 She then specified in her statement on the HHS website, “Today's action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional.”4 This is the same justification that was used by the acting director of the FDA Center for Drug Evaluation and Research to deny approval in 2004. The data from the “actual use study” that are cited by the secretary were obtained by giving free advance access to Plan B to young women 15 to 20 years of age who were already having regular intercourse in order to see whether they used the medication properly when it was available. They did.
To optimize the efficacy of emergency contraception, one must take it as soon as possible after the episode of unprotected intercourse, because the efficacy decreases over time.5 When levonorgestrel is taken as directed, the drug prevents at least 50% of pregnancies. Thus, after an episode of unprotected intercourse, it is critical for a woman to obtain this product rapidly. Introducing age restrictions on its availability necessitates that all prospective purchasers demonstrate that they are older than the specified age (17 years in this case). To do so, they must produce identification before they can even determine whether the pharmacy stocks the product. Having to approach one of their peers working in a store in their neighborhood, identify themselves as having recently had unprotected sex, and provide a document with their name and address will humiliate many women and discourage many from seeking, purchasing, and using the product to prevent an unplanned pregnancy. In addition, many poor or disadvantaged women will be denied access because they do not have a driver's license, passport, or other form of identification with which to verify their age.
In our opinion, the secretary's decision to retain behind-the-counter status for Plan B One-Step was based on politics rather than science. It cannot be based on issues of safety, since a 12-year-old can purchase a lethal dose of acetaminophen in any pharmacy for about $11, no questions asked. The only documented adverse effects of a $50 dose of levonorgestrel are nausea and delay of menses by several days. Any objective review makes it clear that Plan B is more dangerous to politicians than to adolescent girls. Thus, we once again have a situation in which political considerations are forming the basis of public health policy — resulting in another sad day for women.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article (10.1056/NEJMp1114439) was published on December 14, 2011, at NEJM.org.
Source Information
Dr. Wood is a partner at Symphony Capital, New York, and was a member of the FDA Advisory Committee on Nonprescription Drugs; Dr. Drazen is the editor-in-chief of the Journal; and Dr. Greene is an associate editor of the Journal and was a member of the FDA Advisory Committee on Reproductive Health Drugs.
- References
References
1
Sebelius K. Memorandum to Margaret A. Hamburg, M.D. December 7, 2011 (http://www.hhs.gov/news/press/2011pres/12/20111207a.pdf).
2
Food and Drug Administration. Statement from FDA Commissioner Margaret Hamburg, M.D., on Plan B One-Step. December 7, 2011 (http://www.fda.gov/NewsEvents/Newsroom/ucm282805.htm).
3
Wood AJJ ,Drazen JM ,Greene MF . A sad day for science at the FDA. N Engl J Med 2005;353:1197-1199
Full Text | Web of Science | Medline4
Department of Health and Human Services. A statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius. December 7, 2011 (http://www.hhs.gov/news/press/2011pres/12/20111207a.html).
5
von Hertzen H ,Piaggio G ,Ding J , et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet 2002;360:1803-1810
CrossRef | Web of Science | Medline
- Comments (17)
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17 Reader's Comments
MOLLY GILHAM, MD | Physician | Disclosure: NoneSTAUNTON VAJanuary 11, 2012cost and age
Many young girls are clueless as to their risk of pregnancy after a given episode of intercourse. Few of them have $50. As an OBGYN I can't tell you how many I see who tell me a set of menstrual dates that is patently wrong after ultrasound. So my concern is that pregnant women who are deluding themselves will take this.
Tazia Stagg | Physician | Disclosure: NoneDecember 21, 2011the Secretary did her job
The authors' opinion is a strange accusation, since the Sec'y substantiated her decision plenty articulately.
She limited the scope of that statement appropriately, but much more could be said in defense of her conclusion. Accurately predicting the potential harms of the policy change the FDA recommended would be difficult. I doubt that high-quality evidence is available concerning all its imaginable ramifications, but their being difficult to predict makes them no less valid.LORIE HUGHES, MD | Physician | Disclosure: NoneCARTERSVILLE GADecember 21, 2011A Sad Day for Women
Excellent article. The authors have hit the nail on the head with this commentary.
Shiela Overton | Physician | Disclosure: NoneDecember 20, 2011Health Care Provider's Role
Whenever a controversial issue arises, most people scurry to choose which side of the debate they are on and quickly condemn the other side. These responses rarely produce positive results. We, as health care providers, can lessen the impact of this recent ruling on Plan B by providing "Advanced Provision" for Plan B and dispensing it to younger teens "before it is needed". Research shows that utilizing this approach does not cause teens to have more cavalier attitudes about sex or to increase sexual activity.
GIUSEPPE LEONE, MD | Physician - Internal Medicine | Disclosure: NoneROMA RM ItalyDecember 18, 2011The term unprotected intercourse is misleading
I think that unprotected intercourse should be defined as intercourse which does not present any risk of disease. Pregnancy is not a disease. Levonorgestrenol does not protect from any disease. Protected intercourse should be defined as intercourse protected by condo am or between people considered healthy by medical criteria (ie criteria for blood donation).
Pushpa Gross | Physician | Disclosure: NoneDecember 16, 2011Plan B : a small part of the solution
First, I'd love to hear from the authors about use and efficacy data in populations for whom healthcare access is a problem. Is Plan B only for the more affluent? Second,young patients who find themselves in the difficult situation of needing emergency contraception need education and support. Those of us who care for these patients understand that this is really at the heart of this issue. Plan B is like putting a finger in the proverbial dike. Third, what type of financial gain does the manufacturer of Plan B stand to make if the age restriction is lifted? Does this have anything to do with why this issue has resurfaced at this time?
ROBERT MOLINO, MD | Physician | Disclosure: NoneMILL VALLEY CADecember 15, 2011Contrary Effect
Whatever the motive for denying Plan B to younger teens it seems the unintended effect will be more abortions, more unwanted children and generally more misery for
those who are medically unsophisticated.
Perhaps we should call this business as usual.WINSTON HIMSWORTH | Other | Disclosure: NonePlandome NYDecember 15, 2011Number Needed to Treat
Reportedly, use of Plan B can reduce the risk of a pregnancy by half — from 1 in 20 to 1 in 40 — if taken within 3 days.
From a Number Needed to Treat viewpoint, this 50% reduction in risk statistic would translate into an NNT of 40. In other words, for every 40 women taking Plan B, there would be one less pregnancy. Assuming no downside — and one HHS justification for the action was that the drug manufacturer had failed to study whether Plan B was safe for girls as young as 11 — Plan B was better than nothing, but hardly foolproof. Note that Plan B loses effectiveness over time. This is an important point because the underlying issue is whether Plan B should be available to younger girls on a prescription or non-prescription basis. Most likely, the extra time required to obtain a prescription would decrease its effectiveness.BRUCE WELLS, MD | Physician | Disclosure: NoneWINFIELD KSDecember 15, 2011Evidence?
As a retired primary care physician I am intimately familiar with the devastation caused by unplanned pregnancy, moreso in teenagers. I am also aware that evidence-based medicine is by far the best medicine.
Therefore, I wonder what is the evidence that 10 or 11 year olds can safely use this relatively high dose of levonorgestrel. There aren't that many pregnancies in that age group to have provided evidence that they could use the medicine properly, or that it is truly safe in them.
Perhaps a calmer re-evaluation of the drug manufacturer's request might lead to the lowering of the age requirement for OTC use to 14 or 15--an idea which I would heartily recommend.JAMES PRESCOTT PHD | Other | Disclosure: NoneDecember 15, 2011Unwanted Children: A National Tragedy
The CDC reported for the year 2005, a pregnancy rate of 103.2 pregnancies per 1,000 women for the U.S. (15-44 years); and 1.6 pregnancies per 1,000 for females under the age of 15 years where 44% of these pregnancies ended in abortion. Pregnancies rates for 12 year olds and younger were not given.
A prevented unwanted pregnancy transcends what little risk is involved in misused contraception.
Tragically, President Obama has compromised his principles almost beyond repair and he is urged to change course by adopting FDA science recommendations.
President Obama should be supporting the U.S. Constitution—“to promote the general welfare” --rather than supporting specific religious beliefs. The birth of unwanted children--Compulsory Motherhood-- is a disaster and morally repugnant and his decision violates the U..S. Constitution.MICHAEL MUTO, MD | Physician | Disclosure: NoneBOSTON MADecember 15, 2011Cost a Barrier
I wonder how many young girls have fifty dollars in their pocket. There are more than just political barriers at work here.
RAHA SHOJAI, MD | Physician | Disclosure: NoneMARSEILLE FranceDecember 15, 2011Cost still remains an important barrier
In the US, the issue of increased accessibility to emergency contraception for teenagers may be anyhow hampered by the prohibitive cost of this single dose medication. Even if the HHS secretary had not overruled the FDA decision to authorize OTC access for under 16 teenagers, it is uncertain how many adolescents could in reality afford gathering precipitiously 50 USD without parental knowledge to buy the preventive treatment.
Currently in France, 1.5mg levonorgestrel single tablets are provided for free at pharmacy for minors under 18 and without identification check. Pharmacies are then secondarily paid by social security. For women above 18, EC is reimbursed by the state if prescribed by a health care professional and the public price of 1.5mg levonorgestrel is currently less than 10 USD. Despite these relatively easy conditions of access, EC remains underused and unintended pregnancies among adolescents have reached alarming rates, reflecting the need for a more comprehensive strategy in this area of preventive care.J MICHAEL ALBRICH, MD | Physician | Disclosure: NonePORTLAND ORDecember 14, 2011The FDA needs to be structured like the Fed
A recent article in the NY Times suggests that the FDA become an independent entity such as the Fed to remove is from the wind and whim of politics. The political decision to keep Plan B out of the hands of young women powerfully supports the recommendation.
JAI JOSHI, MD | Physician | Disclosure: NoneLAREDO TXDecember 14, 2011Science, Lies and Who Do You think You Are Kidding, Mr. President
These decisions should be left to science. There was a time when I believed that my president could never stand before us and lie. I had specialized in medical oncology and just become a US citizen, and year was 1976.
DR BRUCE STRINGER, MD | Physician | Disclosure: NoneWILLIAMSVILLE NYDecember 14, 2011A sad day for science.
A truly appalling decision by the Obama administration. I suspect there is a fear of alienating, "values based" independent voters and the cynical belief that their core electorate has no other choice in the current Republican herd. Well, this member of that portion of the electorate has been suffering from buyers remorse. Maybe Hillary would have done better?
KENNETH GORELICK, MD | Physician | Disclosure: NoneNEWTOWN SQ PADecember 14, 2011The Hypocrisy of Hope
President Obama's stated policy of leaving scientific decisions to the scientists obviously does not apply to politically sensitive public health issues, Secretary Sebelius' degree in Political Science notwithstanding, her pretended scientific rejection is transparent as she has no scientific standing to overrule the FDA-only political authority.
The trail of broken promises, from Gitmo to the Public Option, is the legacy of the current Administration. The only promises they have kept involve doubling down in Afghanistan and using drones to attack the Taliban in Pakistan. I had at least hoped for truth in decision-making. Sebelius should have simply stated that she did not wish to touch this hot potato in the lead-up to the 2012 elections.
Orwellian language
Recently, scientists have decided to redefine what abortion is. As the authors state: "The best available evidence indicates that it prevents pregnancy largely by delaying or preventing ovulation, but prevention of implantation cannot be ruled out. Levonorgestrel does not cause abortion; it does not terminate an established pregnancy (an implanted conceptus)." Since life begins at conception (a medical/scientific fact)--look it up in any embryology textbook--abortion involves the termination of the embryo from the moment of conception and, therefore, Levonorgestrel has the potential to result in abortion due to its possible prevention of implantation. Changing the definition of abortion to termination of an implanted conceptus is deceiving and not scientifically sound, suggesting that it is actually the authors here who may be playing politics!