**Study #9728: *Plan B* OTC Label Comprehension Study**

*\[This is a medical officer addendum to the detailed review conducted
by Dr. Karen Lechter, a social scientist in the Office of Drug
Safety/HFD-410\]*

Report location: Volume 31

Study date: June 18, 2001 to July 18, 2001

Sponsors: Women's Capital Corporation

Family Health International (FHI)

(The sponsorship was transferred to the Barr Research in Nov, 03)

Investigators: Family Health International (FHI), Research Triangle
Park, NC

(study design and monitoring; data collection, management and analyses)

Study sites: [Eight malls in US]{.underline}:

> Aurora, CO; Northridge, CA; Phoenix, AZ; Matteson, IL; Springfield,
> VA; San Antonio, TX; Deptford, NJ; and Pembroke Pines, FL
>
> [Four Family Planning Clinics sites in US]{.underline}
>
> Boca Raton, FL; Chicago, IL; Los Angeles, CA; and San Antonio, TX

Study Drug: Plan B package containing no tablets

**Study Objectives:**

> To test if consumers can understand the proposed OTC Plan B label.

**Subject Recruitment:**

A total of 663 women were screened from 8 shopping malls and 4 family
planning clinics cross the US (8 States); 656 were enrolled. The
clinical sites were selected for enrollment of subjects that were minors
so that parental consent was not necessary.

**Communication objectives:**

The following 11 communication objectives were tested. (The
corresponding questionnaire follows each objective):

1.  ***Plan B is indicated for prevention of pregnancy after unprotected
    sex.***

> Comprehension: correct or acceptable answers to at least 2 of the 4
> questions.

+------------------------------------+-------------+-------------------+
| **Question**                       | **Co        |                   |
|                                    | mprehension |                   |
|                                    | Response    |                   |
|                                    | s/Answers** |                   |
+------------------------------------+-------------+-------------------+
|                                    | **Correct** | **Incorrect**     |
+------------------------------------+-------------+-------------------+
| Q7: Without looking at the label,  | emergency   | after sex         |
| tell me what *Plan B^®\ ^*is used  | con         | (purpose          |
| for.                               | traception; | unspecified);     |
|                                    |             | STI/HIV;          |
|                                    | (***Acc     | emergency (sex    |
|                                    | eptable:*** | not               |
|                                    | con         |                   |
|                                    | traception) | mentioned);       |
|                                    |             | other; don't      |
|                                    |             | know/refused      |
+------------------------------------+-------------+-------------------+
| Q14: A woman's partner used a      | correct     | Incorrect;        |
| condom during sex with her but the |             | refused           |
| condom broke. The next morning,    |             |                   |
| she used *Plan B^®^* to prevent    |             |                   |
| pregnancy. Was this a correct use  |             |                   |
| of *Plan B^®^*?                    |             |                   |
+------------------------------------+-------------+-------------------+
| Q16: A woman with asthma had       | correct     | Incorrect;        |
| unprotected sex. The next day, she |             | refused           |
| took *Plan B* to prevent           |             |                   |
| pregnancy. Was this a correct use  |             |                   |
| of *Plan B^®^*?                    |             |                   |
+------------------------------------+-------------+-------------------+
| ***Q19:*** A woman had unprotected | correct     | Incorrect;        |
| sex 2 days ago and then used *Plan |             | refused           |
| B^®^* to prevent pregnancy. Was    |             |                   |
| this a correct use of *Plan B^®^*? |             |                   |
+------------------------------------+-------------+-------------------+

2.  ***Plan B is intended as a back up method and should not be used for
    regular contraception.***

> Comprehension: Correct answer to at least 3 (Q8 was not listed under
> this objective, but it appears it should be here) of the following 5
> questions.

  --------------------------------------------- --------------------- ---------------
  **Question**                                  **Comprehension       
                                                Responses/Answers**   

                                                **Correct**           **Incorrect**

  Q8: Is *Plan B^®^* the same as ordinary birth Different             Same; Refused
  control pills or is it different from                               
  ordinary birth control pills?                                       

  Q9: According to the label, should *Plan      No                    Yes; Refused
  B^®^* be used as regular birth control?                             

  Q21: A woman is planning to have sex tonight. Incorrect             Correct;
  She usually uses condoms to prevent                                 Refused
  pregnancy. This time she plans to use *Plan                         
  B^®^* instead because her husband complains                         
  about using condoms. Is this a correct use of                       
  *Plan B^®^*?                                                        

  Q22: A woman used *Plan B* every day instead  Incorrect             Correct;
  of her usual birth control pills. Was this a                        Refused
  correct use of *Plan B^®^*?                                         

  Q25: A woman and her husband don't like using Incorrect             Correct;
  condoms and the woman doesn't want to take                          Refused
  birth control pills. They decide to use *Plan                       
  B^®^* as their main contraceptive method. Is                        
  this a correct use of *Plan B^®^*?                                  
  --------------------------------------------- --------------------- ---------------

3.  ***Plan B does not prevent sexually transmitted diseases or
    HIV/AIDS.***

> Comprehension: correct answer to the following 2 questions

  -------------------------------------- --------------------- ---------------
  **Question**                           **Comprehension       
                                         Responses/Answers**   

                                         **Correct**           **Incorrect**

  Q13: A woman used *Plan B^®^* to be    Incorrect             Correct;
  sure she doesn't get any sexually                            refused
  transmitted diseases. Was this a                             
  correct use of *Plan B^®^*?                                  

  Q27: According to the label, does      No                    Yes; refused
  *Plan B* protect against HIV (the                            
  virus that causes AIDS) and other                            
  sexually transmitted diseases?                               
  -------------------------------------- --------------------- ---------------

4.  ***The first pill should be taken as soon as possible after
    intercourse.***

> Comprehension: correct or acceptable answer to at least 2 of the 4
> questions

+-----------------------------+--------------+------------+------------+
| **Question**                | **C          |            |            |
|                             | omprehension |            |            |
|                             | Respons      |            |            |
|                             | es/Answers** |            |            |
+-----------------------------+--------------+------------+------------+
|                             | **Correct**  | **Ac       | **I        |
|                             |              | ceptable** | ncorrect** |
+-----------------------------+--------------+------------+------------+
| Q10: After unprotected sex, | as soon as   | within 72  | 72 hours   |
| when is the best time to    | possible     | hours      | or 3 days; |
| take the first tablet?      | ***and***    | ***or*** 3 | other;     |
|                             | within 72    | days; as   | don't      |
|                             | hours or 3   | soon as    | kn         |
|                             | days         | possible   | ow/refused |
+-----------------------------+--------------+------------+------------+
| Q29: How many days does the | 3 days or    |            | any other  |
| label say is the longest    |              |            | answer;    |
| after sex a woman should    | 72 hours     |            | refused    |
| wait before taking the      |              |            |            |
| first *Plan B^®^* tablet?   |              |            |            |
+-----------------------------+--------------+------------+------------+
| ***Q19:*** A woman had      | Correct      |            | Incorrect; |
| unprotected sex 2 days ago  |              |            | refused    |
| and then used *Plan B^®^*   |              |            |            |
| to prevent pregnancy. Was   |              |            |            |
| this a correct use of *Plan |              |            |            |
| B^®^*?                      |              |            |            |
+-----------------------------+--------------+------------+------------+
| Q20: A woman had            | Incorrect    |            | Correct;   |
| unprotected sex a week ago  |              |            | refused    |
| and then used *Plan B* to   |              |            |            |
| prevent pregnancy. Was this |              |            |            |
| a correct use of *Plan      |              |            |            |
| B^®^*?                      |              |            |            |
+-----------------------------+--------------+------------+------------+

5.  ***The first pill should be taken within 72 hours after
    intercourse.***

> Comprehension: correct or acceptable answer to either of the following
> questions.

+-----------------------------+--------------+------------+------------+
| **Question**                | **C          |            |            |
|                             | omprehension |            |            |
|                             | Respons      |            |            |
|                             | es/Answers** |            |            |
+-----------------------------+--------------+------------+------------+
|                             | **Correct**  | **Ac       | **I        |
|                             |              | ceptable** | ncorrect** |
+-----------------------------+--------------+------------+------------+
| Q10: After unprotected sex, | as soon as   | within 72  | 72 hours   |
| when is the best time to    | possible     | hours      | or 3 days; |
| take the first tablet?      | ***and***    | ***or*** 3 | other;     |
|                             | within 72    | days;      | don't know |
|                             | hours or 3   |            | or refused |
|                             | days         | as soon as |            |
|                             |              | possible   |            |
+-----------------------------+--------------+------------+------------+
| Q26: Will *Plan B^®^* be    | 1 day        |            | both the   |
| more effective if a woman   |              |            | same; 2    |
| takes it 1 day after        |              |            | days;      |
| unprotected sex or if she   |              |            | refused    |
| takes it 2 days after       |              |            |            |
| unprotected sex?            |              |            |            |
+-----------------------------+--------------+------------+------------+

6.  ***The second pill should be taken 12 hours after the first***.

> Comprehension: correct or acceptable answer to the following question
> 30 (Q23 was not listed under this objective by the sponsor).

  ------------------------------ --------------------- ---------------- ---------------
  **Question**                   **Comprehension                        
                                 Responses/Answers**                    

                                 **Correct**           **Acceptable**   **Incorrect**

  Q23: A woman took both *Plan   Incorrect                              Correct;
  B^®^* tablets at the same                                             Refused
  time. Was this a correct use                                          
  of *Plan B^®^*?                                                       

  Q30: When should a woman take  12 hours after the    other but        other; don't
  the 2^nd^ *Plan B^®^* tablet?  first tablet          mentioned 12     know/refused
                                                       hours; the next  
                                                       morning          
  ------------------------------ --------------------- ---------------- ---------------

7.  ***Plan B should not be used by women who are already pregnant
    (because it will not be effective).***

> Comprehension: correct answer to either of questions 11 and 17

  ------------------------------------- --------------------- ---------------
  **Question**                          **Comprehension       
                                        Responses/Answers**   

                                        **Correct**           **Incorrect**

  Q11: Suppose I told you a woman who   Incorrectly           Correctly;
  is 2 months pregnant used *Plan                             refused
  B^®^*. Would you say she used *Plan                         
  B^®^* correctly or incorrectly?                             

  Q12: Why? (following Q11)             because she was       other reason;
                                        already pregnant, it  don't know or
                                        won't work, it's too  refused
                                        late                  

  Q17: A woman has missed her period.   Incorrect             Correct;
  She did a home pregnancy test and it                        Refused
  was positive. She then used *Plan                           
  B^®^* because she didn't want to be                         
  pregnant. Was this a correct use of                         
  *Plan B^®^*?                                                
  ------------------------------------- --------------------- ---------------

8.  ***Plan B should not be used by women with unexplained vaginal
    bleeding***

> Comprehension: correct answer to the following question

  -------------------------------------- --------------------- ---------------
  **Question**                           **Comprehension       
                                         Responses/Answers**   

                                         **Correct**           **Incorrect**

  Q15: A woman had unusual vaginal       Incorrect             Correct;
  bleeding during the past week. She had                       Refused
  unprotected sex and then she took                            
  *Plan B^®^* to prevent pregnancy. Was                        
  this a correct use of *Plan B^®^*?                           
  -------------------------------------- --------------------- ---------------

9.  ***Plan B should not be used by women with allergy to any ingredient
    in the product.***

> Comprehension: correct answer to the following question

+--------------------------------------+----------------+--------------+
| **Question**                         | *              |              |
|                                      | *Comprehension |              |
|                                      | Respo          |              |
|                                      | nses/Answers** |              |
+--------------------------------------+----------------+--------------+
|                                      | **Correct**    | *            |
|                                      |                | *Incorrect** |
+--------------------------------------+----------------+--------------+
| Q18: A woman knows she is allergic   | Incorrect      | Correct;     |
| to an ingredient in *Plan B^®^*. She |                | Refused      |
| used *Plan B^®^* because she noticed |                |              |
| that her partner's condom broke      |                |              |
| during sex with her. Was this a      |                |              |
| correct use of                       |                |              |
|                                      |                |              |
| *Plan B^®^*?                         |                |              |
+--------------------------------------+----------------+--------------+

10. ***Side effects of Plan B^®^ include nausea and vomiting.***

> Comprehension: correct answer to questions 32 and 34, or name nausea
> and vomiting to question 37, or yes to questions 32-36.

  -------------------------------------- --------------------- ---------------
  **Question**                           **Comprehension       
                                         Responses/Answers**   

                                         **Correct**           **Incorrect**

  Q32: Can nausea be a side effect of    Yes                   No; Refused
  *Plan B^®^*?                                                 

  Q33: Can trouble breathing be a side   No                    Yes; Refused
  effect of *Plan B^®^*?                                       

  Q34: Can vomiting be a side effect of  Yes                   No; Refused
  *Plan B^®^*?                                                 

  Q35: Can fever be a side effect of     No                    Yes; Refused
  *Plan B* ?                                                   

  Q36: Are there any other possible side Yes                   No; Refused
  effects that I haven't mentioned?                            

  Q37: Please name one of these other    named a condition     did not name
  possible side effects.                 listed on package     condition
                                                               listed on
                                                               package;
                                                               refused
  -------------------------------------- --------------------- ---------------

11. ***If severe abdominal pain develops, the user should seek medical
    care immediately.***

> Comprehension: correct answer to the following question

  ------------------------------ --------------------- ---------------------
  **Question**                   **Comprehension       
                                 Responses/Answers**   

                                 **Correct**           **Incorrect**

  Q31: According to the label,   See/call a doctor     See/call a doctor but
  if a woman gets severe stomach (time not mentioned); not immediately; stop
  pain after using Plan B, what  see/call a doctor     using it; call number
  should she do?                 immediately           on box; other; don't
                                                       know/refused
  ------------------------------ --------------------- ---------------------

12. ***Outcome after taking Plan B***

> Comprehension: correct or acceptable answer to the following question

  -------------------------------- --------------------- ---------------- ---------------
  **Question**                     **Comprehension                        
                                   Responses/Answers**                    

                                   **Correct**           **Acceptable**   **Incorrect**

  Q28: After a woman takes *Plan   at about the normal   1 week late      immediately;
  B^®^*, when should she expect    time                                   never; refused
  her next period? Should she                                             
  expect it immediately, at about                                         
  the normal time, 1 week late, or                                        
  never?                                                                  
  -------------------------------- --------------------- ---------------- ---------------

**RESULTS**

**Subject Demographics**

***Age and Race:*** The median age of 656 subjects was 21 years (12-50
years) and approximately 11% of them (76 of 656) were ages 12-16 (Table
2). Half of the participants were Caucasians and about 23% were
Hispanic.

***Table 2.* Demographics of 656 Eligible Subjects**

+-----------------------------------------+---------------+-----------+
| > **Demographic Characteristics**       | **Number**    | **%**     |
+-----------------------------------------+---------------+-----------+
| > ***Age (years)***                     |               |           |
+-----------------------------------------+---------------+-----------+
| > 12-16                                 | 76            | 11.6      |
+-----------------------------------------+---------------+-----------+
| > 17-25                                 | 355           | 54.1      |
+-----------------------------------------+---------------+-----------+
| > 26-50                                 | 225           | 34.3      |
+-----------------------------------------+---------------+-----------+
| > ***Race***                            |               |           |
+-----------------------------------------+---------------+-----------+
| > White                                 | 324           | 49.4      |
+-----------------------------------------+---------------+-----------+
| > Black                                 | 155           | 23.6      |
+-----------------------------------------+---------------+-----------+
| > Asian or Pacific Islander             | 30            | 4.6       |
+-----------------------------------------+---------------+-----------+
| > American Indian or Alaska native      | 6             | 0.9       |
+-----------------------------------------+---------------+-----------+
| > Other                                 | 115           | 17.5      |
+-----------------------------------------+---------------+-----------+
| > Refused/missing                       | 26            | 4.0       |
+-----------------------------------------+---------------+-----------+
| > ***Ethnicity***                       |               |           |
+-----------------------------------------+---------------+-----------+
| > Hispanic                              | 154           | 23.5      |
+-----------------------------------------+---------------+-----------+
| > non Hispanic                          | 500           | 76.2      |
+-----------------------------------------+---------------+-----------+
| > Refused/missing                       | 2             | 0.3       |
+-----------------------------------------+---------------+-----------+
| > ***Income***                          |               |           |
+-----------------------------------------+---------------+-----------+
| > 0-\$15,000                            | 57            | 8.7       |
+-----------------------------------------+---------------+-----------+
| > \$15,001-\$25,000                     | 63            | 9.6       |
+-----------------------------------------+---------------+-----------+
| > \$25,001-\$35,000                     | 101           | 15.4      |
+-----------------------------------------+---------------+-----------+
| > \$35,001-\$45,000                     | 111           | 16.9      |
+-----------------------------------------+---------------+-----------+
| > \$45,001 or more                      | 159           | 24.2      |
+-----------------------------------------+---------------+-----------+
| > did not know                          | 139           | 21.2      |
+-----------------------------------------+---------------+-----------+
| > refused/missing                       | 26            | 4.0       |
+-----------------------------------------+---------------+-----------+
| > ***Marital status***                  |               |           |
+-----------------------------------------+---------------+-----------+
| > single                                | 487           | 74.2      |
+-----------------------------------------+---------------+-----------+
| > married                               | 143           | 21.8      |
+-----------------------------------------+---------------+-----------+
| > divorced                              | 17            | 2.6       |
+-----------------------------------------+---------------+-----------+
| > widowed                               | 8             | 1.2       |
+-----------------------------------------+---------------+-----------+
| > refused/missing                       | 1             | 0.2       |
+-----------------------------------------+---------------+-----------+

> Data were adapted from the sponsor's Table 2 (pa16, vol 31)

***Education and Literacy:*** Approximately 27% of subjects (178 of 656)
had educational levels less than high school (Table 3). About 30% of
subjects (139 of 395) ≥ 18 years of age who had not completed college
were at a literacy level of ≤ 8^th^ grade.

***Sexual activity and Contraception:*** About 79% (474 of 599 who
responded) of subjects were sexually experienced; 71% of subjects (314
of 440 who responded) had a history of unprotected intercourse with
concern about an unwanted pregnancy at some time in the past; 89% (410
of 460) of subjects used a condom.

***Previous EC experience:*** Six percent (32 of 473 who responded) had
previously used emergency contraceptive pills.

***Table 3.* Education and Literacy**

+-------------------------------------+-----------------+--------------+
| ***Education (highest level         | **No of         | **% of 656** |
| completed)***                       | subjects**      |              |
+-------------------------------------+-----------------+--------------+
| > 6^th^ grade or less               | 4               | 0.6          |
+-------------------------------------+-----------------+--------------+
| > 7^th^ or 8^th^ grade              | 26              | 4.0          |
+-------------------------------------+-----------------+--------------+
| > 9^th^-11^th^ grade                | 148             | 22.6         |
+-------------------------------------+-----------------+--------------+
| > high school or GED                | 199             | 30.3         |
+-------------------------------------+-----------------+--------------+
| > vocational/technical school       | 18              | 2.7          |
+-------------------------------------+-----------------+--------------+
| > less than 4 years college         | 117             | 17.8         |
+-------------------------------------+-----------------+--------------+
| > college                           | 105             | 16.0         |
+-------------------------------------+-----------------+--------------+
| > graduate school                   | 37              | 5.6          |
+-------------------------------------+-----------------+--------------+
| > refused/missing                   | 2               | 0.3          |
+-------------------------------------+-----------------+--------------+
|                                     |                 |              |
+-------------------------------------+-----------------+--------------+
| > ***Literacy level***\*            | **No of         | **% of 395** |
| >                                   | subjects**      |              |
| > **Subjects age ≥ 18 not completed |                 |              |
| > college, n=395**                  |                 |              |
+-------------------------------------+-----------------+--------------+
| > 3^rd^ grade or less               | 1               | 0.3          |
+-------------------------------------+-----------------+--------------+
| > 4^th^-6^th^ grade                 | 17              | 4.3          |
+-------------------------------------+-----------------+--------------+
| > 7^th^-8^th^ grade                 | 121             | 30.6         |
+-------------------------------------+-----------------+--------------+
| > high school                       | 254             | 64.3         |
+-------------------------------------+-----------------+--------------+
| > missing                           | 2               | 0.5          |
+-------------------------------------+-----------------+--------------+

> \*Assessed using Rapid Estimate of Adult Literacy in Medicine (Davis
> TC, Long SW, Jackson RH, et al. Rapid estimate of adult literacy in
> medicine: a shortened screening instrument. Fam Med 1993;25:391-5.)

**Comprehension of Communication Objectives**

Comprehension rates for each communication objective are summarized in
Table 4, which corresponds to the following parameters evaluating
marketability of OTC drug:

***Indication:*** Ninety-three percent of subjects understood that *Plan
B^®^* is indicated for prevention of pregnancy after unprotected sex
(objective 1).

***Warning:***

1.  Pregnancy: 98% of subjects understood that Plan B should not be used
    by pregnant women; (objective #7)

2.  Unexplained vaginal bleeding: 75% of subjects understood that Plan B
    should not be used by women with unexplained vaginal bleeding;
    (objective #8)

3.  Allergy: 91% of subjects understood that Plan B should not be used
    by women with allergy to any ingredient in the product. (objective
    #9)

***Regular contraception:*** Sixty-seven percent of subjects understood
that Plan B is intended as a back up method and should not be used for
regular contraception (objective #2).

***HIV and other STDs:*** Ninety-four percent of subjects understood
that Plan B does not protect against HIV or any other sexually
transmitted disease (objective #3).

***Direction for Use:*** Ninety-seven percent of subjects understood
that the first pill should be taken within 72 hours or as soon as
possible after intercourse (objective #4/5). Sixty-nine percent of
subjects understood that the second pill should be taken 12 hours after
the first (objective #6).

***Adverse Events:*** Eight-nine percent of subjects understood that
side effects of Plan B include nausea and vomiting (objective #10). Two
irrelevant side-effects, "fever" and "trouble breathing," were included
in the questionnaires; 80% and 83% of subjects, respectively, responded
that "fever" and "trouble breathing" were not side effects of Plan B.
However, if subjects responded that both relevant and irrelevant AEs
were side-effects of Plan B, the responses were considered as correct.
Therefore, the true comprehension on "nausea" and "vomiting" would be
less than 89%.

***Management of serious complication:*** Eight-one percent of subjects
understood that if severe abdominal pain develops, the user should seek
medical care immediately (objective #11).

***Table 4.* Comprehension of each communication objectives**

(% of enrolled subjects)

+---+--------------------------------+----------+--------+-----------+
| * |                                |          | **Resp | **95%     |
| * |                                |          | onse** | C         |
| C |                                |          |        | onfidence |
| o |                                |          |        | I         |
| m |                                |          |        | nterval** |
| m |                                |          |        |           |
| u |                                |          |        |           |
| n |                                |          |        |           |
| i |                                |          |        |           |
| c |                                |          |        |           |
| a |                                |          |        |           |
| t |                                |          |        |           |
| i |                                |          |        |           |
| o |                                |          |        |           |
| n |                                |          |        |           |
| O |                                |          |        |           |
| b |                                |          |        |           |
| j |                                |          |        |           |
| e |                                |          |        |           |
| c |                                |          |        |           |
| t |                                |          |        |           |
| i |                                |          |        |           |
| v |                                |          |        |           |
| e |                                |          |        |           |
| s |                                |          |        |           |
| * |                                |          |        |           |
| * |                                |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > *Plan B^®^* is indicated for | >        | 90     | 0.87 -    |
|   | > prevention of pregnancy      |  Correct |        | 0.92      |
| 1 | > after unprotected sex †      |          |        |           |
+---+--------------------------------+----------+--------+-----------+
|   |                                | > Acce   | 93     | 0.91 -    |
|   |                                | ptable\* |        | 0.95      |
+---+--------------------------------+----------+--------+-----------+
| > | > *Plan B^®^* is intended as a |          | 67     | 0.64 -    |
|   | > back up method and should    |          |        | 0.71      |
| 2 | > not be used for regular      |          |        |           |
|   | > contraception.               |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > *Plan B^®^* does not prevent |          | 94     | 0.92 -    |
|   | > sexually transmitted         |          |        | 0.96      |
| 3 | > diseases or HIV/AIDS.        |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > The first pill should be     |          | 85     | 0.82 -    |
|   | > taken within 72 hours after  |          |        | 0.88      |
| 4 | > intercourse.                 |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > The first pill should be     |          | 82     | 0.79 -    |
|   | > taken as soon as possible    |          |        | 0.85      |
| 5 | > after intercourse.           |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > The first pill should be     |          | 97     | 0.96 -    |
|   | > taken within 72 hours or     |          |        | 0.98      |
| 4 | > ASAP after intercourse       |          |        |           |
| / |                                |          |        |           |
| 5 |                                |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > The second pill should be    | >        | 69     | 0.65 -    |
|   | > taken 12 hours after the     |  Correct |        | 0.72      |
| 6 | > first.                       |          |        |           |
+---+--------------------------------+----------+--------+-----------+
|   |                                | > Acce   | 85     | 0.83 -    |
|   |                                | ptable\* |        | 0.88      |
+---+--------------------------------+----------+--------+-----------+
| > | > *Plan B^®^* should not be    |          | 98     | 0.97 -    |
|   | > used by women who are        |          |        | 0.99      |
| 7 | > already pregnant             |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > *Plan B^®^* should not be    |          | 75     | 0.72 -    |
|   | > used by women with           |          |        | 0.79      |
| 8 | > unexplained vaginal bleeding |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > *Plan B^®^* should not be    |          | 91     | 0.88 -    |
|   | > used by women with allergy   |          |        | 0.93      |
| 9 | > to any ingredient in the     |          |        |           |
|   | > product                      |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > Side effects of *Plan B^®^*  |          | 89     | 0.87 -    |
|   | > include nausea and vomiting. |          |        | 0.91      |
| 1 |                                |          |        |           |
| 0 |                                |          |        |           |
+---+--------------------------------+----------+--------+-----------+
| > | > If severe abdominal pain     |          | 81     | 0.78 -    |
|   | > develops, the user should    |          |        | 0.84      |
| 1 | > seek medical care            |          |        |           |
| 1 | > immediately.                 |          |        |           |
+---+--------------------------------+----------+--------+-----------+

Data were extracted from the sponsor's Table 8 (p30, vol 31).

\* The acceptable responses included "correct" responses.

***Comprehension rates among subjects with different Demographics***

> [Ages]{.underline} (Table 5): Significantly fewer subjects ages 12-16
> understood objectives #1A, #2, #4 and #6 compared with those ages ≥ 17
> years.
>
> [Education and Literacy]{.underline} (Tables 6a & b): Lower
> comprehension rates on correct self-selection (related to objectives
> 1A, 2, 3 and 4) of Plan B were found in subjects who did not complete
> high school, as compared to those who completed high school. Subjects
> at age 18 or older with ≤ 8^th^ grade literacy scored significantly
> lower on objectives related to self-selection/deselection and correct
> use. Only 46% of the low literacy group understood that Plan B was not
> intended for routine contraception.
>
> [Study Sites]{.underline} (Table 7): Approximately 89% of subjects
> (583 of 656) were recruited from family planning clinics and the rest,
> 11% (73 of 656) from shopping malls in the original sNDA submission.
> However, in the sponsor's response (October 30, 2003) to the Agency'
> request on comparing the demographics of subjects between both
> locations, the proportion of the subjects recruited from both location
> was transposed; the sponsor claimed that 89% subjects were from the
> malls and 11% from the clinics.
>
> Overall comprehension on the proposed OTC label was comparable between
> the clinics and the malls, except that the subjects in shopping malls
> demonstrated significantly less understanding of side-effects based on
> the original sNDA submission. However, when subjects were stratified
> based on demographics provided in the new submission (assuming that
> the transposed locations were correct), the following subgroups of
> subjects from the clinics had lower comprehension on some
> communication objectives such as such as "used as a back-up but not
> for regular contraception": age 12-16, low income (≤ \$15,000/yr), low
> education (\< HS), and no prior EC experience. The comprehension rate
> on "not for regular contraception" in subjects age 12-16 was 20% in
> the clinics and 61% in mall.

***Table 5.* Comprehension rate of communication objectives in different
age groups**

(% of enrolled subjects)

+---+--------------------------------+-------+-------+-------+-------+
| * |                                | **Age |       |       | **To  |
| * |                                | (yea  |       |       | tal** |
| C |                                | rs)** |       |       |       |
| o |                                |       |       |       | **N=  |
| m |                                |       |       |       | 656** |
| m |                                |       |       |       |       |
| u |                                |       |       |       |       |
| n |                                |       |       |       |       |
| i |                                |       |       |       |       |
| c |                                |       |       |       |       |
| a |                                |       |       |       |       |
| t |                                |       |       |       |       |
| i |                                |       |       |       |       |
| o |                                |       |       |       |       |
| n |                                |       |       |       |       |
| O |                                |       |       |       |       |
| b |                                |       |       |       |       |
| j |                                |       |       |       |       |
| e |                                |       |       |       |       |
| c |                                |       |       |       |       |
| t |                                |       |       |       |       |
| i |                                |       |       |       |       |
| v |                                |       |       |       |       |
| e |                                |       |       |       |       |
| s |                                |       |       |       |       |
| * |                                |       |       |       |       |
| * |                                |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
|   |                                | **12  | **17  | **26  |       |
|   |                                | -16** | -25** | -50** |       |
|   |                                |       |       |       |       |
|   |                                | **n   | **n=  | **n=  |       |
|   |                                | =76** | 355** | 255** |       |
+---+--------------------------------+-------+-------+-------+-------+
| 1 | > *Plan B^®^* is indicated for | **86^ | 93    | 95    | 93    |
| A | > prevention of pregnancy      | \#^** |       |       |       |
| † | > after unprotected sex.       |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 2 | > *Plan B^®^* is intended as a | *     | 67    | 71    | 67    |
|   | > back up method and should    | *57** |       |       |       |
|   | > not be used for regular      |       |       |       |       |
|   | > contraception.               |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 3 | > *Plan B^®^* does not prevent | 9     | 96    | 92    | 94    |
|   | > sexually transmitted         | 3^\#^ |       |       |       |
|   | > diseases or HIV/AIDS.        |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 4 | > The first pill should be     | *     | 86    | 87    | 85    |
|   | > taken within 72 hours after  | *77** |       |       |       |
|   | > intercourse.                 |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 5 | > The first pill should be     | 84    | 83    | 81    | 82    |
|   | > taken as soon as possible    |       |       |       |       |
|   | > after intercourse.           |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 4 | > 4 or 5 The first pill should | 94    | 97    | 98    | 97    |
| / | > be taken within 72 hours or  |       |       |       |       |
| 5 | > ASAP after intercourse.      |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 6 | > The second pill should be    | **7   | 90    | 82    | 86    |
| A | > taken 12 hours after the     | 7\*** |       |       |       |
| ‡ | > first. ‡                     |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 7 | > *Plan B^®^* should not be    | 97    | 99    | 97    | 98    |
|   | > used by women who are        |       |       |       |       |
|   | > already pregnant.            |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 8 | > *Plan B^®^* should not be    | 72    | 77    | 74    | 75    |
|   | > used by women with           |       |       |       |       |
|   | > unexplained vaginal          |       |       |       |       |
|   | > bleeding.                    |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 9 | > *Plan B^®\ ^*should not be   | 90    | 91    | 91    | 91    |
|   | > used by women with allergy   |       |       |       |       |
|   | > to any ingredient in the     |       |       |       |       |
|   | > product.                     |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 1 | > Side effects of *Plan        | 90\*  | 93    | 84    | 89    |
| 0 | > B^®\ ^*include nausea and    |       |       |       |       |
|   | > vomiting.                    |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+
| 1 | > If severe abdominal pain     | 81    | 84    | 77    | 81    |
| 1 | > develops, the user should    |       |       |       |       |
|   | > seek medical care            |       |       |       |       |
|   | > immediately                  |       |       |       |       |
+---+--------------------------------+-------+-------+-------+-------+

Data were extracted from the sponsor's Table 9 (p30).

\* P \< 0.01 and \# P \< 0.05

† using acceptable definition for Q7; ‡ using acceptable definition for
Q30.

***Table 6a.* Comprehension rates on communication objective at
different education levels**

(% of enrolled subjects)

+---+------------------------------------+---------+---------+-------+
| * |                                    | **Educ  |         | **To  |
| * |                                    | ation** |         | tal** |
| C |                                    |         |         |       |
| o |                                    |         |         | **n=  |
| m |                                    |         |         | 654** |
| m |                                    |         |         |       |
| u |                                    |         |         |       |
| n |                                    |         |         |       |
| i |                                    |         |         |       |
| c |                                    |         |         |       |
| a |                                    |         |         |       |
| t |                                    |         |         |       |
| i |                                    |         |         |       |
| o |                                    |         |         |       |
| n |                                    |         |         |       |
| O |                                    |         |         |       |
| b |                                    |         |         |       |
| j |                                    |         |         |       |
| e |                                    |         |         |       |
| c |                                    |         |         |       |
| t |                                    |         |         |       |
| i |                                    |         |         |       |
| v |                                    |         |         |       |
| e |                                    |         |         |       |
| s |                                    |         |         |       |
| * |                                    |         |         |       |
| * |                                    |         |         |       |
+---+------------------------------------+---------+---------+-------+
|   |                                    | **\<    | **≥     |       |
|   |                                    | HS**    | HS**    |       |
|   |                                    |         |         |       |
|   |                                    | **      | **      |       |
|   |                                    | n=178** | n=476** |       |
+---+------------------------------------+---------+---------+-------+
| 1 | *Plan B^®^* is indicated for       | *       | 96      | 93    |
| A | prevention of pregnancy after      | *86\*** |         |       |
| † | unprotected sex.                   |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 2 | *Plan B^®^* is intended as a back  | *       | 72      | 67    |
|   | up method and should not be used   | *55\*** |         |       |
|   | for regular contraception.         |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 3 | *Plan B^®^* does not prevent       | **9     | 96      | 94    |
|   | sexually transmitted diseases or   | 0^\#^** |         |       |
|   | HIV/AIDS.                          |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 4 | The first pill should be taken     | *       | 89      | 85    |
|   | within 72 hours after intercourse. | *77\*** |         |       |
+---+------------------------------------+---------+---------+-------+
| 5 | The first pill should be taken as  | 85      | 81      | 82    |
|   | soon as possible after             |         |         |       |
|   | intercourse.                       |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 4 | The first pill should be taken     | 97      | 97      | 97    |
| / | within 72 hours or ASAP after      |         |         |       |
| 5 | intercourse                        |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 6 | The second pill should be taken 12 | 84      | 86      | 86    |
| A | hours after the first.             |         |         |       |
| ‡ |                                    |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 7 | *Plan B^®^* should not be used by  | 97      | 98      | 98    |
|   | women who are already pregnant.    |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 8 | *Plan B^®^* should not be used by  | 75      | 75      | 75    |
|   | women with unexplained vaginal     |         |         |       |
|   | bleeding.                          |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 9 | *Plan B^®\ ^*should not be used by | 88      | 92      | 91    |
|   | women with allergy to any          |         |         |       |
|   | ingredient in the product.         |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 1 | Side effects of *Plan              | 88      | 90      | 89    |
| 0 | B^®\ ^*include nausea and          |         |         |       |
|   | vomiting. (P=0.0075)               |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 1 | If severe abdominal pain develops, | 84      | 80      | 81    |
| 1 | the user should seek medical care  |         |         |       |
|   | immediately.                       |         |         |       |
+---+------------------------------------+---------+---------+-------+

> Data were extracted from the sponsor's Table 15 (p37).
>
> † using acceptable definition for Q7; ‡ using acceptable definition
> for Q30.
>
> \* P \< 0.01 and \# p \< 0.05
>
> \< HS: did not complete high school; ≥ HS: completed high school

***Table 6b.* Comprehension rates on communication objective at
different literacy levels**

(% of enrolled subjects)

+---+------------------------------------+---------+---------+-------+
| * |                                    | **L     |         | **To  |
| * |                                    | iteracy |         | tal** |
| C |                                    | Level** |         |       |
| o |                                    |         |         | **n=  |
| m |                                    |         |         | 393** |
| m |                                    |         |         |       |
| u |                                    |         |         |       |
| n |                                    |         |         |       |
| i |                                    |         |         |       |
| c |                                    |         |         |       |
| a |                                    |         |         |       |
| t |                                    |         |         |       |
| i |                                    |         |         |       |
| o |                                    |         |         |       |
| n |                                    |         |         |       |
| O |                                    |         |         |       |
| b |                                    |         |         |       |
| j |                                    |         |         |       |
| e |                                    |         |         |       |
| c |                                    |         |         |       |
| t |                                    |         |         |       |
| i |                                    |         |         |       |
| v |                                    |         |         |       |
| e |                                    |         |         |       |
| s |                                    |         |         |       |
| * |                                    |         |         |       |
| * |                                    |         |         |       |
+---+------------------------------------+---------+---------+-------+
|   |                                    | **≤     | **HS**  |       |
|   |                                    | 8^th^** |         |       |
|   |                                    |         | **      |       |
|   |                                    | **      | n=254** |       |
|   |                                    | n=139** |         |       |
+---+------------------------------------+---------+---------+-------+
| 1 | *Plan B^®^* is indicated for       | 84\*    | 96      | 92    |
| A | prevention of pregnancy after      |         |         |       |
| † | unprotected sex.                   |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 2 | *Plan B^®^* is intended as a back  | 46\*    | 78      | 67    |
|   | up method and should not be used   |         |         |       |
|   | for regular contraception.         |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 3 | *Plan B^®^* does not prevent       | 84\*    | 99      | 93    |
|   | sexually transmitted diseases or   |         |         |       |
|   | HIV/AIDS.                          |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 4 | The first pill should be taken     | 71\*    | 90      | 83    |
|   | within 72 hours after intercourse. |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 5 | The first pill should be taken as  | 84      | 83      | 83    |
|   | soon as possible after             |         |         |       |
|   | intercourse.                       |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 4 | The first pill should be taken     | 95      | 98      | 97    |
| / | within 72 hours or ASAP after      |         |         |       |
| 5 | intercourse                        |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 6 | The second pill should be taken 12 | 82\*    | 92      | 89    |
| A | hours after the first.             |         |         |       |
| ‡ |                                    |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 7 | *Plan B^®^* should not be used by  | 95\*    | 99      | 98    |
|   | women who are already pregnant.    |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 8 | *Plan B^®^* should not be used by  | 69\*    | 81      | 77    |
|   | women with unexplained vaginal     |         |         |       |
|   | bleeding.                          |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 9 | *Plan B^®\ ^*should not be used by | 82\*    | 95      | 90    |
|   | women with allergy to any          |         |         |       |
|   | ingredient in the product.         |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 1 | Side effects of *Plan              | 84\*    | 96      | 92    |
| 0 | B^®\ ^*include nausea and          |         |         |       |
|   | vomiting. (P=0.0075)               |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 1 | If severe abdominal pain develops, | 81      | 83      | 82    |
| 1 | the user should seek medical care  |         |         |       |
|   | immediately.                       |         |         |       |
+---+------------------------------------+---------+---------+-------+

> Data were extracted from the sponsor's Table 16 (p38).
>
> † using acceptable definition for Q7; ‡ using acceptable definition
> for Q30.
>
> \* P \< 0.01
>
> \< 8^th^: 8^th^ grade or less assessed with REALM test; HS: completed
> high school

**Table 7. Comprehension rates in subjects recruited from Shopping Mall
and Clinics**

**(% of enrolled subjects)**

+---+------------------------------------+---------+---------+-------+
| * |                                    | **Study |         | **To  |
| * |                                    | Site    |         | tal** |
| C |                                    | s^\#^** |         |       |
| o |                                    |         |         | **n=  |
| m |                                    |         |         | 656** |
| m |                                    |         |         |       |
| u |                                    |         |         |       |
| n |                                    |         |         |       |
| i |                                    |         |         |       |
| c |                                    |         |         |       |
| a |                                    |         |         |       |
| t |                                    |         |         |       |
| i |                                    |         |         |       |
| o |                                    |         |         |       |
| n |                                    |         |         |       |
| O |                                    |         |         |       |
| b |                                    |         |         |       |
| j |                                    |         |         |       |
| e |                                    |         |         |       |
| c |                                    |         |         |       |
| t |                                    |         |         |       |
| i |                                    |         |         |       |
| v |                                    |         |         |       |
| e |                                    |         |         |       |
| s |                                    |         |         |       |
| * |                                    |         |         |       |
| * |                                    |         |         |       |
+---+------------------------------------+---------+---------+-------+
|   |                                    | *       | **C     |       |
|   |                                    | *Mall** | linic** |       |
|   |                                    |         |         |       |
|   |                                    | **      | *       |       |
|   |                                    | n=583** | *n=73** |       |
+---+------------------------------------+---------+---------+-------+
| 1 | *Plan B^®^* is indicated for       | 93      | 93      | 93    |
| A | prevention of pregnancy after      |         |         |       |
| † | unprotected sex.                   |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 2 | *Plan B^®^* is intended as a back  | 68      | 61      | 67    |
|   | up method and should not be used   |         |         |       |
|   | for regular contraception.         |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 3 | *Plan B^®^* does not prevent       | 94      | 97      | 94    |
|   | sexually transmitted diseases or   |         |         |       |
|   | HIV/AIDS.                          |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 4 | The first pill should be taken     | 85      | 87      | 85    |
|   | within 72 hours after intercourse. |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 5 | The first pill should be taken as  | 83      | 79      | 82    |
|   | soon as possible after             |         |         |       |
|   | intercourse.                       |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 4 | The first pill should be taken     | 97      | 98      | 97    |
| / | within 72 hours or ASAP after      |         |         |       |
| 5 | intercourse                        |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 6 | The second pill should be taken 12 | 85      | 90      | 86    |
| A | hours after the first.             |         |         |       |
| ‡ |                                    |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 7 | *Plan B^®^* should not be used by  | 98      | 98      | 98    |
|   | women who are already pregnant.    |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 8 | *Plan B^®^* should not be used by  | 75      | 76      | 75    |
|   | women with unexplained vaginal     |         |         |       |
|   | bleeding.                          |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 9 | *Plan B^®\ ^*should not be used by | 91      | 93      | 91    |
|   | women with allergy to any          |         |         |       |
|   | ingredient in the product.         |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 1 | Side effects of *Plan              | *       | 98      | 89    |
| 0 | B^®\ ^*include nausea and          | *88\*** |         |       |
|   | vomiting.                          |         |         |       |
+---+------------------------------------+---------+---------+-------+
| 1 | If severe abdominal pain develops, | 81      | 83      | 81    |
| 1 | the user should seek medical care  |         |         |       |
|   | immediately.                       |         |         |       |
+---+------------------------------------+---------+---------+-------+

> Data were extracted from the sponsor's Table 13 (p35).
>
> \* P \< 0.01 (by Chi-square test).
>
> † using acceptable definition for Q7; ‡ using acceptable definition
> for Q30.
>
> \# The proportion of subjects from clinics and malls is updated from
> the sponsor's re-submission dated on October 30, 2003. In the original
> submission (April 2003), 583 subjects were recruited from clinic sites
> and 73 from shopping malls; the sponsor claimed this was transposed.

**SUMMARY**

1.  ***Subjects:*** A total of 656 subjects (663 were screened) ages
    12-50 were enrolled in the study; approximately 12% of subjects were
    age 12-16; 30% of subjects at age ≥ 18 who did not complete college
    were at a literacy level ≤ 8^th^ grade. About 79% of subjects were
    sexually experienced and 6% had previous EC use experience.

2.  ***Comprehension of Indication:*** Ninety-three percent of subjects
    could correctly understand that Plan B is to be used "after
    unprotected sex".

3.  ***Comprehension on Warning:*** Most subjects (91-98%) could
    understand the warnings (pregnancy and allergy) and that Plan B does
    not protect against the AIDS/STDs. However, only 67% of subjects
    could understand that Plan B is not for use as a regular
    contraceptive; and 75% of subjects were aware of the
    contraindication "unexplained vaginal bleeding".

4.  ***Comprehension on correct use:*** Ninety-seven percent of subjects
    understood to take the first pill before 72 hours or as soon as
    possible after intercourse. However, only 69% of subjects understood
    the need to take the second pill at 12 hours after the first pill.

5.  ***Adverse events:*** Over 80% of subjects could understand side
    effects of Plan B.

6.  ***Ages:*** Lower comprehension rates were seem on the communication
    objectives #1A, #2, #4 and #6 in subjects ages 12-16 and on #1A, #2,
    #3 and #4 in subjects with lower literacy and less than a high
    school education.

7.  ***Education levels:*** Lower comprehension rates on the
    communication objectives #1A, #2, #3 and #4 in subjects with lower
    literacy and less than high school education.

8.  ***Shopping Malls and Clinics:*** Overall comprehension rates on the
    communication objectives were comparable between the 2 types of
    locations, except for the lower comprehension of the possible
    adverse events demonstrated by participants from the malls. However,
    among demographic cohorts, there were trends of lower comprehension
    on some elements in the proposed OTC label in the clinic sites
    compared to the malls, particularly among subjects ages 12-16, those
    with less education, and those with low literacy.

9.  ***STDs or HIV/AIDS:*** Ninety-four percent of subjects understood
    that Plan B does not prevent STDs or HIV/AIDS. However, the
    comprehension was less among the younger (12-16 years old) and lower
    literacy participants.

**COMMENTS**

1.  Approximately 20% of subjects did not understand the potential
    seriousness of severe abdominal pain that may occur after using
    Plan B. This issue (related to ectopic pregnancy) will be addressed
    in the global safety update review by HFD-580.

2.  Approximately 25% of subjects did not recognize that "unexplained
    vaginal bleeding" was a contraindication. The language may be too
    vague. The sponsor stated that there is no evidence to support this
    contraindication claim and proposed to remove it from the label.
    This issue will be addressed in the global safety update review by
    HFD-580.

3.  Sexually transmitted diseases other than HIV/AIDS were not mentioned
    in the questionnaires.

4.  The proportion of subjects from the clinics and the malls in the
    study was unclear because the sponsor reported them differently. In
    the original submission the sponsor reported that 89% of subjects
    were recruited from the clinics and 11% were from the malls.
    However, upon resubmission of this data, the sponsor rectified this
    error and stated that 89% of subjects were from the malls.

**CONCLUSION**

1.  Overall, the majority of subjects could understand the proposed OTC
    label with regard to the indication for Plan B, and could recognize
    common and severe adverse events.

2.  Subjects ages 12-16 and those with less education or low literacy
    were less apt to comprehend the indication and the directions for
    use.

3.  A package insert is recommended to improve comprehension of concepts
    of "emergency" and "routine" contraception in populations with lower
    literacy and those ages 12-16.

4.  The proposed changes on the OTC label from the sponsor: bolding the
    phrase "a serious medical problem" and removing "Unexplained (or
    unusual) vaginal bleeding". Acceptability of this label will be
    determined by the AU study results.

5.  The majority of study subjects were recruited from a mall setting.
    This would probably more closely represent the general population
    than those subjects recruited in the actual use study and would help
    to evaluate the generalizability of label comprehension.

**APPENDIX:**

**The Proposed OTC label used for the Label Comprehension Study**

> ![](media/image1.png){width="4.03125in" height="5.75in"}
>
> ![](media/image2.png){width="3.6458333333333335in"
> height="1.125in"}![](media/image3.png){width="4.020833333333333in"
> height="4.25in"}
>
> ![](media/image4.png){width="3.34375in" height="2.9791666666666665in"}

**Plan B Label used for the Label Comprehension Study**

![](media/image5.png){width="10.061805555555555in"
height="5.022222222222222in"}