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Case Study: Plan B

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Case Study: Plan B

1) I do not believe that the FDA should be able to make exceptions to the standard drug-approval process. If there does need to be a change in the way the drug is being approved, once the drug has gone through the normal flow of approval processes and has been deemed to be safe, low risk of abuse, and provides an acceptable therapeutic index, there should be no reason that the drug does not go through the normal approval process.
2) All drugs have some level of safety concern. In the case of if acetaminophen were available in prescription form only, there would most definitely be an influx of patients to clinics and emergency rooms seeking pain medications for headaches, body aches, or other minor pain related incidences.
3) I do not think that there should be additional data required for girls of reproductive potential for Plan B or other OTC products. If half of all girls in high school are already sexually active, they should have the tools available to them in order to prevent unexpected pregnancies. Many schools offer free condoms as well as sexual health classes to inform students of the risks of being sexually active, I believe that Plan B is just one more tool available to women in order to be in charge of their bodies. While I do not think that this should be passed out like condoms are, I do think that it should be available to women if it is needed such as when a condom breaks or slips off during sex, she is raped, or even if contraception is forgotten to be used.
I do think that it should be considered different than other contraceptive products, however; because it is intended for emergency purposes only. A condom and/or other forms of contraception should be used while engaging in sexual activity to increase protection against STIs as well as unwanted pregnancies. I do believe, as previously stated, it should be made

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