RxCompliance Report Survey

1. The new PhRMA Code states: “Promotional materials provided to healthcare professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications."

Based on this provision, what is your response to the following statement:

The new PhRMA Code sends a signal that it is not only company employees who are at risk if they deviate from accepted regulatory and legal practices. Vendors (e.g., advertising, medical education, and public relations) that provide services to a drug or device company are also accountable.

The new PhRMA Code states: “Promotional materials provided to healthcare professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications." Based on this provision, what is your response to the following statement: The new PhRMA Code sends a signal that it is not only company employees who are at risk if they deviate from accepted regulatory and legal practices. Vendors (e.g., advertising, medical education, and public relations) that provide services to a drug or device company are also accountable. Completely agree with statement

Somewhat agree with statement

Neither agree nor disagree with statement

Somewhat disagree with statement

Completely disagree with statement

2. How knowledgeable do you think communication agencies working for your company are about regulatory considerations as they develop materials and programs?

How knowledgeable do you think communication agencies working for your company are about regulatory considerations as they develop materials and programs? Extremely knowledgeable

Very knowledgeable

Somewhat knowledgeable

Not very knowledgeable

Not at all knowledgeable

3. How concerned are you that programs and materials (including e-mails) developed by your communication agencies could turn out to be sources of trouble in litigation?

How concerned are you that programs and materials (including e-mails) developed by your communication agencies could turn out to be sources of trouble in litigation? Extremely concerned

Very concerned

Somewhat concerned

Not very concerned

Not at all concerned

4. How many hours per month would you estimate your organization spends reworking press materials submitted by your public relations agencies to bring them into compliance?

How many hours per month would you estimate your organization spends reworking press materials submitted by your public relations agencies to bring them into compliance? 0

1 – 8

9 - 20

21 - 40

41 and over

5. How many hours per month would you estimate your organization spends reworking collateral advertising submitted by your advertising agencies to bring them into compliance?

How many hours per month would you estimate your organization spends reworking collateral advertising submitted by your advertising agencies to bring them into compliance? 0

1 - 8

9 - 20

21 - 40

41 and over

6. How many hours per month would you estimate your organization spends reworking promotional medical education materials (e.g. slide kits) submitted by your agencies to bring them into compliance?

How many hours per month would you estimate your organization spends reworking promotional medical education materials (e.g. slide kits) submitted by your agencies to bring them into compliance? 0

1 - 8

9 - 20

21 - 40

41 and over

7. How many days per month would you estimate that your internal review committee would save if materials were prepared only by professionals with a certified understanding of regulatory compliance?

How many days per month would you estimate that your internal review committee would save if materials were prepared only by professionals with a certified understanding of regulatory compliance? 0

4 or more

8. How comfortable would you be to know that vendors (e.g., advertising, promotional medical education, and public relations agencies) employed by your organization were certified in regulatory compliance?

How comfortable would you be to know that vendors (e.g., advertising, promotional medical education, and public relations agencies) employed by your organization were certified in regulatory compliance? Extremely comfortable

Very comfortable

Somewhat comfortable

Not very comfortable

Not at all comfortable

9. What level of agreement do you have with the following statement:

Requiring vendors (e.g., advertising, promotional medical education, and PR agencies) to be trained and certified in regulatory compliance should be a corporate compliance best practice.

What level of agreement do you have with the following statement: Requiring vendors (e.g., advertising, promotional medical education, and PR agencies) to be trained and certified in regulatory compliance should be a corporate compliance best practice. Completely agree with statement

Somewhat agree with statement

Neither agree nor disagree with statement

Somewhat disagree with statement

Completely disagree with statement

10. Procurement (or a company's contracting department) should make regulatory compliance training and certification for vendors a key criteria when assigning Agency of Record (preferred) status.

Procurement (or a company's contracting department) should make regulatory compliance training and certification for vendors a key criteria when assigning Agency of Record (preferred) status. Strongly agree with statement

Somewhat agree with statement

Neither agree nor disagree with statement

Somewhat disagree with statement

Completely disagree with statement

RxCompliance Report Survey

1. Default Section

2. How knowledgeable do you think communication agencies working for your company are about regulatory considerations as they develop materials and programs?

3. How concerned are you that programs and materials (including e-mails) developed by your communication agencies could turn out to be sources of trouble in litigation?

4. How many hours per month would you estimate your organization spends reworking press materials submitted by your public relations agencies to bring them into compliance?

5. How many hours per month would you estimate your organization spends reworking collateral advertising submitted by your advertising agencies to bring them into compliance?

6. How many hours per month would you estimate your organization spends reworking promotional medical education materials (e.g. slide kits) submitted by your agencies to bring them into compliance?

7. How many days per month would you estimate that your internal review committee would save if materials were prepared only by professionals with a certified understanding of regulatory compliance?

8. How comfortable would you be to know that vendors (e.g., advertising, promotional medical education, and public relations agencies) employed by your organization were certified in regulatory compliance?

9. What level of agreement do you have with the following statement:Requiring vendors (e.g., advertising, promotional medical education, and PR agencies) to be trained and certified in regulatory compliance should be a corporate compliance best practice.

10. Procurement (or a company's contracting department) should make regulatory compliance training and certification for vendors a key criteria when assigning Agency of Record (preferred) status.

9. What level of agreement do you have with the following statement:

Requiring vendors (e.g., advertising, promotional medical education, and PR agencies) to be trained and certified in regulatory compliance should be a corporate compliance best practice.