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Plan B® One-Step Approval – Advocacy Q&A

July 10, 2009

Top Questions

  1. What is Plan B® One-Step?

New Plan B® One-Step is an innovative one-pill emergency contraceptive that can help prevent an unintended pregnancy in just one dose.

2. What’s the difference between Plan B® One-Step and original Plan B®?

Plan B® One-Step can prevent an unintended pregnancy with just one pill that can be taken right away, while the original product is two tablets taken 12 hours apart.

3. What’s the benefit of Plan B® One-Step?

Plan B® One-Step is just one pill that’s taken in one dose, so women can act quickly and take it right away. Emergency contraception is more effective the sooner it’s taken.

4. Why create a one-pill product when the two-tablet product is effective?

We believe Plan B® One-Step is a better option because it’s just one pill that’s taken in one dose, so women can act quickly and take it right away. Emergency contraception is more effective the sooner it’s taken.

5.Does the recent court ruling that was in the news apply to Plan B® One-Step?

Plan B® One-Step will be available with new age parameters. Plan B® One-Step will be available OTC at the pharmacy for consumers age 17 or older with government-issued proof-of-age identification. Women younger than age 17 will require a prescription to purchase Plan B® One-Step.

6. Generic EC may become available this summer. Why take Plan B® One-Step when there’s a generic option that costs less?

We believe Plan B® One-Step is a better option because it’s just one pill that’s taken in one dose, so women can act quickly and take it right away. Emergency contraception is more effective the sooner it’s taken.

7. Why pay more for Plan B® One-Step when you could just take both generic pills together?

When taking any drug, follow FDA-approved labeling instructions. Plan B® One-Step is just one pill that can be taken right away. With two-pill EC, each pill must be taken separately 12 hours apart.

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8. Plan B® One-Step is double the dose of two tablets. Won’t the side effects be worse?

Plan B® One-Step’s potential side effects are similar to those of the two-tablet product. The most common side effects includechanges in your period, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness.

9. Will Teva continue selling the two-tablet Plan B® product?

Teva is discontinuing the two-tablet product.

10. Where is Plan B® One-Step sold?

Plan B® One-Step is sold only at licensed retail pharmacies, from behind the pharmacy counter.

11. Who can buy Plan B® One-Step?

Plan B® One-Step will be available with new age parameters. Now, Plan B® One-Step will be available OTC at the pharmacy for consumers age 17 or older with government-issued proof-of-age identification. Women younger than age 17 will require a prescription to purchase Plan B® One-Step.

12. When will Plan B® One-Step be available?

Plan B® One-Step will be available at licensed pharmacies at the end of July 2009.

13. How much will OTC Plan B® One-Step cost?

Pharmacies set their own price, so the cost may vary. The average price is approximately $45.

Product Overview Questions

1. How effective is Plan B® One-Step?

When taken as directed, within 72 hours (3 days) of unprotected sex or contraceptive failure, Plan B® One-Step is highly effective in reducing the chance of pregnancy. About seven out of eight women who would have gotten pregnant will not become pregnant after taking it. Plan B® One-Step should be taken as soon as possible after unprotected sex—the sooner it is taken, the more effective it will be. Plan B® One-Step will NOT work if a woman is already pregnant and it will NOT terminate an existing pregnancy.

  1. The original Plan B® is 89% effective, is the one-pill formulation less effective?

The studies conducted for Plan B® and Plan B® One-Step were two distinct studies with different study designs, populations and endpoints. When taken as directed, within 72 hours (3 days) of unprotected sex or contraceptive failure, Plan B® One-Step is highly effective in reducing the chance of pregnancy. About seven out of eight women who would have gotten pregnant will not become pregnant after taking it. Plan B® One-Step should be taken as soon as possible after unprotected sex—the sooner it is taken, the more effective it will be. With that being said, the most recent study was a

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comparative study and Plan B® One-Step was shown to be 84% effective, while the original two-pill product was only 79% effective.

  1. Why would someone take the new one-pill formulation when the original is more effective and less expensive?

That is not accurate. The studies conducted for Plan B® and Plan B® One-Step were two distinct studies with different study designs, populations and endpoints. When taken as directed, within 72 hours (3 days) of unprotected sex or contraceptive failure, Plan B® One-Step is highly effective in reducing the chance of pregnancy. About seven out of eight women who would have gotten pregnant will not become pregnant after taking it. Plan B® One-Step should be taken as soon as possible after unprotected sex—the sooner it is taken, the more effective it will be.

  1. If the original Plan B® is 89% effective. What is the effectiveness of Plan B® One-Step?

When taken as directed, within 72 hours (3 days) of unprotected sex or contraceptive failure, Plan B® One-Step is highly effective in reducing the chance of pregnancy. About seven out of eight women who would have gotten pregnant will not become pregnant after taking it. Plan B® One-Step should be taken as soon as possible after unprotected sex—the sooner it is taken, the more effective it will be.

  1. But what percentage does 7 out of 8 equate to?

To about 84%, but please be aware that the studies conducted for Plan B® and Plan B® One-Step were two distinct studies with different study designs, populations and endpoints. With that being said, the most recent study was a comparative study and Plan B® One-Step was shown to be 84% effective, while the original two-pill product was only 79% effective.

6. How does Plan B® One-Step work?

New Plan B® One-Step is an innovative one-pill emergency contraceptive that can help prevent an unintended pregnancy in just one dose. Plan B® One-Step is a single oral tablet containing 1.5 mg levonorgestrel–an ingredient in many primary birth control pills.

7. Will Plan B® One-Step work if a woman is already pregnant?

Plan B® One-Step will NOT work if a woman is already pregnant and it will NOT terminate an existing pregnancy.

8. When should Plan B® One-Step be taken?

New Plan B® One-Step is an innovative one-pill emergency contraceptive that can prevent an unintended pregnancy in just one dose. Take it as soon as possible within 72 hours of contraceptive failure or unprotected sex—but the sooner you take it, the more effective it will be.

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9. Is Plan B® One-Step safe?

The FDA has ruled that Plan B® One-Step is safe and effective.

10. How will a woman feel after taking Plan B® One-Step?

Plan B® One-Step is safe for most women, when taken as directed. The most common side effects includechanges in your period, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness.

11. How does a woman know that Plan B® One-Step has prevented pregnancy?

After taking Plan B® One-Step, you should consider the possibility of being pregnant if your period is delayed more than a week beyond its expected date.

12. How many times can a woman take Plan B® One-Step?

Although there is no evidence that repeated use of Plan B® One-Step is harmful, it is intended for emergency use only and isn’t a replacement for primary contraception.

13. How soon after taking Plan B® One-Step can a woman have sex?

You can have sex immediately after taking Plan B®One-Step, but should use a condom or another back-up birth control method until your next period. You are not protected against pregnancy from sex that occurs after you have taken Plan B® One-Step.

14. Does Plan B® One-Step prevent STIs?

Plan B® One-Step does not protect against HIV or other sexually transmitted infections.

15. Can men purchase Plan B® One-Step?

Plan B® One-Step will be available OTC at the pharmacy for consumers age 17 or older with government-issued proof-of-age identification. Women younger than age 17 will require a prescription to purchase Plan B® One-Step.

12. Is Plan B® One-Step covered by insurance?

When sold as a prescription product, Plan B® One-Step is covered by many insurance plans.

13. Do the OTC and Rx products look the same?

Both the OTCand prescription products have the same packaging—but a prescription sticker is adhered to the package for women younger than 17.

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Controversial Questions

1. Is Plan B® One-Step the same as RU-486?

Plan B® One-Step is NOT RU-486 or the “abortion pill.” Plan B® One-Step is an emergency contraceptive that prevents pregnancy after unprotected sex or contraceptive failure. It will not work if you’re already pregnant and will not terminate an existing pregnancy.

2. People have differing opinions on when pregnancy occurs---so isn’t it true that Plan B® One-Step CAN interfere with pregnancy?

The American College of Obstetricians and Gynecologists (ACOG) defines pregnancy as successful implantation of a fertilized egg. Plan B® One-Step does NOT work once a fertilized egg has implanted.

3. Won’t availability of a one-pill EC product promote women to act irresponsibly?

Studies in Journal of the American Medical Association (2005) andObstetrics and Gynecology (2005) show that OTC access DOES NOT lead to risky sex.

4. Doesn’t OTC access minimize the issue of risky sexual behavior?

Studies in Journal of the American Medical Association (2005) andObstetrics and Gynecology (2005) show that OTC access DOES NOT lead to risky sex.

5. Don’t studies show that EC doesn’t reduce unintended pregnancy rates?

A Contraception (2006) study notes that expanding EC access is an important step to

reducing unintended pregnancy. According to an Obstetrics & Gynecology (2007)

article, women who use EC may be more likely to adopt more effective contraception methods.

6. Does Plan B® One-Step affect a woman’s long-term fertility?

Plan B® One-Step does not affect long-term fertility and there have been no serious complications associated with it.

7. Plan B® One-Step is very expensive at my pharmacy—why?

Teva supplies Plan B® One-Step at a fixed price, and retail pharmacies set their own price.

8. How do providers ensure that OTC Plan B® One-Step does not fall into the hands of women under the age of 17?

Teva has an extensive monitoring program in place that tracks pharmacist adherence to Plan B® One-Step dispensing guidelines.

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