Even though America has, by far, the highest rates of unwanted and unplanned teenage pregnancies in the developed world, and the FDA wanted to make the Morning-After-Pill, otherwise known as Plan B One-Step, available as an over-the-counter (OTC) drug to all females of reproductive age, HHS Secretary Kathleen Sebelius slapped them down and said “No”. So, the drug continues as an OTC for females aged 17 years or more, and a prescription-only one for females below 17.
The outcry is growing. Many say this is another example of politics doing things for the sake of politics, rather than responding to sound science and acting in the public good. In America, there are presidential elections next year and many niche votes to win – at times like this, politics is king, say hundreds of Americans who have been writing in with their comments.
Assistant commissioner for women’s health at the FDA in 2005, Susan Wood, resigned after frustration at political foot-dragging in approving the emergency contraceptive as an OTC medication. When President Barack Obama came into power four years later, Wood was overjoyed, because the new President emphasized that his administration would base its decisions on sound science, on facts, rather than politics.
Kathleen Sebelius can try to argue that the evidence before her regarding younger females being able to use the medication according to its labeled instructions is not convincing. Most people believe the truth to be different, that had the FDA proposed this status change for Plan B One-Step at the beginning of an Administration’s four-year term, she would probably not have intervened.
A doctor (who wished to remain anonymous) wrote in, saying:
“So, because of politics, thousands and thousands more American teenage girls will go on to have unwanted pregnancies.”
Asked whether she is now disappointed, Susan Wood said she is far beyond that. Experts say that no presidential administration has ever before publicly overruled the FDA in this manner.
Susan Wood said:
“This is contrary to the scientific integrity memo signed by Obama. It’s contrary to the whole principal of making decisions based on science and evidence. (The decision sets) a terrible precedent for the whole breadth and depth of the FDA”
FDA Commissioner, Margaret Hamburg M.D., responded to Sebelius’ move in a letter of protest, which was posted on the FDA’s website.
Hamburg wrote (part of the letter is quoted):
“”I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.
Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.”
President Obama said that this was Sebelius’ decision and he had not been involved in it. Susan Wood said that she is glad Hamburg responded as she did – FDA employees are demoralized by this move; Hamburg’s letter will help somewhat.
Some experts are now wondering whether this very public overruling will undermine people’s faith in the FDA. Will companies decide not to bother submitting some new compounds for approval for fear of political bullying? Will this uncertainty result in fewer effective therapies for illnesses and conditions?
Economics is classed as a science in most countries around the world. Several European economists criticized the Euro during its formation, saying that it was being created by politicians, rather than experts who would be guided by scientific (economic) facts. Today the Euro is in trouble, precisely for the reasons expressed many years ago – and Europe is now paying a big price.
Teenage pregnancy rates in America are considerably higher than in Western Europe, Canada and Australasia. Changing the status of a morning-after-pill to OTC for all ages would have meant that a girl, say of 16 would have been able to simply go to a pharmacy and have the pill within a day or two of having unprotected sex. Now, as before, she will have to go to a doctor and get a prescription. A sizeable percentage of these girls will not see a doctor, for various reasons, perhaps money, procrastination, embarrassment, etc., some of whom will become evidently pregnant. Most girls of reproductive age in other developed nations are not face by such hurdles.
In most other developed nations where restrictions exist, either they have a teenage pregnancy rate which is a fraction of America’s, or the restrictions are less severe. For example, in the UK, since 2005, the morning-after-pill is available OTC for any female aged 16+. In France, school nurses are allowed to dispense them free of charge. In Canada, emergency contraception (morning after pill) is available OTC in most provinces and territories.
The USA has the highest teenage pregnancy rate in the developed world. Access to emergency contraception is easier in most of the other developed countries
One can argue until one is blue in the face about the rights and wrongs of any issue – a good advocate, lawyer or politician can argue either way effectively, depending on what side of the fence he/she represents.
Science however, does not lie, it is based on facts. And the fact is, as seen in the map above – America has a serious teenage pregnancy problem; the statistics speak for themselves. It is also a fact that a higher percentage of younger girls in other developed nations are given scientifically based sex education, and have better access to sexual health services and medications.
Written by Christian Nordqvist