Plan B 1

FDA makes Plan B available

US District Court Judge Reverses Decision of the FDA Age Restriction for Plan B, over-the- Counter Emergency Contraception

US District Court Judge Reverses Decision of the FDA Age Restriction for Plan B, over-the- Counter Emergency Contraception

The politicians were at it again, and this time caught the Bush Administration in the line of fire. Judge Edward, R Korman published a 52-page decision stating politicians interfered with science and medicine for theological reasons. The Plan B pill is emergency contraception. The only way to get the product over-the-counter after years of denied applications from the Food and Drug Administration was for Duramed to offer a compromise. The compromise was creating an age restriction the made the pharmaceutical prescription required for girls under the age of 18 to prevent promiscuity in young girls (Stein, FDA Ordered to Rethink Age Restriction for Plan B, 2009).

The Food and Drug Administration denied the application initially. The submitted study had a large broad base of females; the limited amount girls’ age 14-16 years old involved with the study, were not enough to justify making the medication as over-the- counter for this age group. The admitted argument is, the Pro-life administration of the White House (at the time) played a role in controlling contraception based on the premise that would the vaccine makes the decision to be promiscuous for young girls easier (Stein, FDA Ordered to Rethink Age Restriction for Plan B, 2009). The Bush Administration placed watered down pro-life limits on the age group.

The Administration did not violate the constitution, but did interfere with a woman’s legal right to choose no matter the age. The ethical conflict involves denying rights of females based on sexual promiscuity of young girls’ verses denying the application for an inadequate study. The ovulating female has the same hormonal cycle age does not factor into the cycle. There was overwhelming support to protect foolish girls from having sex. It is not up to the government to impose limits on what should be a private family decision.

“This ruling comes in response to a lawsuit filed by the Center for Reproductive Rights against the FDA for its failure to make emergency contraception Plan B available over-the-counter. The lawsuit claimed that the FDA broke its own rules and regulations, ignored medical consensus, as well as the expertise of its own scientists and advisory committees by holding Plan B to an arbitrarily higher standard than other OTC products. The plaintiffs asked the court to order the FDA to make Plan B available over-the-counter for women of all ages” (US District Court Finds the FDA'S Action on Plan B(R) Tainted by Politics, 2009). All one has to do is review the separation of church and state to understand what the Bush administration and the FDA did was unethical (Jefferson, 1802).

This morning Rob Stein of the Washington Post reports that the Bush Administration influenced the Plan B emergency contraception age limits (Stein, FDA Ordered to Rethink Age Restriction for Plan B, 2009). The three years from the initial request to convert the Plan B pill from prescription to- over-the-counter resulted in throwing out the decision of majority rule in favor of the conversion. However, the committee member, a minster by the name of W. David Hager, a believer in pro-life said that he did not use his influence as an Evangelical Christian, but as a reviewer of scientific information that he says did not include enough information regarding young teens and the use of the contraception (Kaufman, 2005). Mr. Hager contends that the White House requested that he resign his post to take the committee position to use his influence to stall the process.

Susan Wood resigned from the FDA and in her letter stated the level of improprieties is more than she will tolerate. “At the Food and Drug Administration, the director of the Office of Women's Health recently resigned because she believed that the administration was twisting science to stall approval of over-the-counter emergency contraception” (The Politics of Science, 2006).

The emergency contraception Plan B allows women whom had unprotected sex to take the pill to prevent pregnancy. Duramed, a subsidiary of Barr pharmaceuticals the makers of the Plan B drug provided documented scientific evidence of a safe and an effective method of pregnancy prevention if taken with in 72 hours. The medication is a higher dose of Progestin, which is a natural hormone circulating within the female body. Regular birth control pills use Progestin. The Plan B medication when taken correctly prevents women from ovulating, if the egg has not dropped into the uterus (FDA's Decision Regarding: Plan B Questions and Answers, 2006). If the egg and the sperm join, it will prevent implantation on to the uterine wall. If the plantation has happened prior to taking the medication, the medication will not prevent pregnancy at this point, according to the FDA website (2006).

The original issue started when Barr pharmaceuticals applied to the FDA to make the product Plan B an over-the-counter medication. The application met resistance, leading to the denial of the application. The basis for the denial was that the availability of the medication would increase promiscuity. Stein says, “…Plan B can cause the equivalent of an abortion” (2009). The letter of initial denial (see appendix I) stated the reason for denial was insufficient information submitted regarding girls ages 14-16 represented in the study submitted (Galson, 2004). Kristen Moore President of Reproductive Health Technologies Project stated that Galson acted alone in his decision to deny the application against his own panel of experts (2004-see appendix III). It became a known fact that Galson acted alone in his decision. Kirsten Moore, also, commented in another press release (Appendix II) after the initial decision to prevent Plan B was disallowed, “This decision blatantly disregards the overwhelming scientific evidence that supports over-the-counter Plan B® and ignores the health-based verdict of the FDA’s own experts. Worst of all, the Bush Administration has denied American women timely access to a safe, proven second chance to prevent pregnancy” (2004).

Along the same argument, Rob Stein published an article subsequent to Plan B. The column describes the introduction three years ago of the Gardasil vaccine, for the Human Papiloma Virus (Stein, A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market, 2009). The vaccine provides protection against this sexually transmitted disease. The virus causes cervical cancer in females. The discussion Stein quotes as a debate back then was, “Would the shots make young girls more likely to have sex” (A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market, 2009)? The makers of Gardasil applied for approval with the Food and Drug Administration to sell the vaccine to males. Stein argues that it would make young males have sex; rather it discusses cost, and effectiveness (A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market, 2009). In males, it provides protection against venereal warts, penile cancer, throat, and anal cancer that are complications, of the virus in men (Stein, A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market, 2009). Stein, in an interview with Susan M. Reverby quoted, “We are still more worried about the promiscuity of girls than the promiscuity of boys…There’s still that double standard” (A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market, 2009).

The issue of pregnancy prevention and vaccination against sexually transmitted diseases today has effectively conveyed the wishes of the scientists in today’s society. The concern is not that young girls are having sex, but the complications young girls have because of sex. Parents are not capable of watching young girls all the time. Parents have to trust that the daughters will make sound logical decisions. Parents can hope the daughters will abstain, rather than let hormones guide them. Sometimes, it is an impossible battle. In the state of Maryland, young girls do not need parental consent if the girl decides to use contraception. Young girls have the right to go to these appointments without the parent’s knowledge or permission.

When it comes to discussing solutions to young girls having sex, parents cannot decide for the girls. This is one decision that parents are usually not involved in. One way that does protect young girls is to provide them with the vaccine. Let them know it is not because the parents think they are promiscuous, rather the vaccine will afford these girls the opportunity to avoid being a statistic when the time comes.

Young girls are going to have sex if they want to have sex. Temptation is a terrible thing. The reality is that if; after all, the discussions regarding sex, and the responsibility fail, then the parents’ choices are limited. Do parents want this behavior to continue? The reality is that parental guidance, theological guidance at times is no match for hormones. Is it really in the parents’ best interest to continue to stand firm on abstinence, when clearly that method does not always meet with success?

References

FDA's Decision Regarding: Plan B Questions and Answers. (2006, August 24). Retrieved March 23, 2009, from The Food and Drug Administration: http://www.fda.gov/CDER/DRUG/infopage/planB/planBQandA.htm

Galson, S. (2004, May 6). Letter. Washington, DC. Retrieved March 23, 2009, from Food and Drug Administration: http://www.fda.gov/CDER/DRUG/infopage/planB/planB_NALetter.pdf

Jefferson, T. (1802, January 1). Thomas Jefferson Papers Timeline: Letter to Danbury Baptists. Retrieved March 23, 2009, from Library of Congress: http://www.loc.gov/exhibits/religion/danburys.jpg

Kaufman, M. (2005, May 12). Memo May Have Swayed Plan B Ruling FDA Received 'Minority Report' From Conservative Doctor on Panel. Washington, DC. Retrieved March 24, 2009, from Reproductive Health Technologires Project: http://www.rhtp.org/science/documents/Minorityreport.asp

Moore, K. (2004, May 6). FDA Ruling Against Over-the-counter Plan B® Is a Shocking, Unprecedented Triumph of Politics over Science. Washington, DC. Retrieved March 21, 2009, from Reproductive Health Technologies Project: http://www.rhtp.org/news/pr/documents/PR.FDA%20Ruling%20Against%20OTC%20Plan%20B%20is%20shocking.doc

Stein, R. (2009, March 26). A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market. (Maryland). Washington , DC. Retrieved 26 2009, 2009, from Washingtonpost.com: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/25/AR2009032503682.html

Stein, R. (2009, March 24). FDA Ordered to Rethink Age Restriction for Plan B. (Maryland). Washington, DC. Retrieved March 24, 2009, from washingtonpost.com: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/23/AR2009032301275.html

The Politics of Science. (2006, February 9). Washington, DC. Retrieved March 24, 2009, from Reproductive Health Technologies Project: http://www.rhtp.org/science/attacks/PoliticsofScience.asp

US District Court Finds the FDA'S Action on Plan B(R) Tainted by Politics. (2009, March 23). Retrieved March 24, 2009, from Foxbusiness.com: http://www.foxbusiness.com/story/markets/industries/retail/district-court-finds-fdas-actions-plan-br-tainted-politics/