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ISSUE 119 VOL 4 PUBLISHED 10/7/2005

FDA needs a 'Plan B'

By Danielle Daniel
Staff Writer

Friday, October 7, 2005

The resignation of Lester Crawford from his position as commissioner of the Food and Drug Administration (FDA) has created speculation that a turbulent and controversial year is to blame for forcing out the doctor of veterinary medicine after only two months on the job and just over one year as acting commissioner.

Two of the biggest controversies during Crawford’'s administration were the voluntary recall of Vioxx by its manufacturer, Merck, and the dilemma over whether the over-the-counter sale of the emergency contraceptive drug, Plan B, is appropriate and safe. While drug recalls are business as usual for the FDA (though not so usual for such a widely prescribed drug as Vioxx), the additional delay in the decision to make Plan B an over-the-counter item is a politically sensitive issue for pro-life advocates and for those who feel that the “morning after” pill is sexually irresponsible.

This tension between politics, ethics and science is likely what prompted Crawford to resign, especially considering that he was appointed by President Bush to use his expertise to safeguard the nation'’s food supply from bioterrorism, not to face the criticism and obstacles to scientific progress that arise from the clash of differing belief systems.

In fact, Crawford'’s resignation came soon after Susan F. Wood, the director of the office of women'’s health at the FDA, quit to protest the “abortion politics” which she believed had devalued the medical evidence in support of making Plan B available to women older than 16 years of age over the counter.

If emergency contraceptives are comprised of the hormones estrogen and progestin and prevent pregnancy in the same fashion as birth control, then what makes Plan B seemingly harmful? Isn’'t it safer for a woman’s health and more cost-effective to take Plan B after sex than to possibly have an abortion later or to give birth to an unwanted child?

Wood believed so strongly in the safety of this drug that she was willing to resign. I, too, while definitely not a supporter of unprotected sex, think that Plan B should be easily accessible to women who fear pregnancy.

While some may say that women should be required to get a prescription for Plan B in order to receive counseling and to be placed on birth control on a regular basis, the cost of Plan B (about $30 for two tablets) makes it an unrealistic way to prevent pregnancy.

In fact, after spending $30 on Plan B, one is probably more likely to remember to use condoms, which actually protect against sexually transmitted diseases as well and are often available free from health centers (including those on campus), or monthly prescription birth control, which in generic form costs as much as one dose of Plan B.

Several weeks before his resignation, Crawford stated that the FDA had to delay the approval of Plan B as an over-the-counter drug because it did not know how to establish a protocol for monitoring a medication which would be indicated for the same treatment both by prescription and over-the-counter.

He was concerned as well about how to ensure that only women older than 16 years of age could purchase the medication without a prescription, due to research that found the drug is safest for women at least 17 years old.

I would rather the FDA approve Plan B for over-the-counter use (OTC), but still control the drug by placing it behind the pharmacy counters to ensure that only women older than 16 years of age may purchase it. This method has helped pharmacies control other over-the-counter drugs successfully, such as products containing pseudophedrine.

With the possible availability of Plan B as an OTC drug, I do not think women will abandon more realistic and conventional forms of birth control, including condoms. Rather, Plan B is another safe way for a woman to make sure that when she does get pregnant it is by her own, planned choice.

Contributing writer Danielle Daniel is a junior from Northfield, Minn. She majors in English.

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