What's your regulatory IQ, part 5

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And some more questions from this Alliance for CME session:

Question: Can sales reps distribute brochures announcing CME activities?

1. No, the guidelines prohibit this

2. Yes, but the provider has to request and approve of their involvement

3. Only when it s permissible by the supporting company s policies

The audience voted 11 percent for the first option, 71 percent for the second, and 18 percent for the third. The pharma presenter said that most, if not all, companies have a policy on this. "We would review every piece our reps are asked to distribute. We do allow brochures, and maybe CME if it s sealed in shrink-wrap and contains no off-label information."

Question: Can brochures be distributed from an exhibit booth during a congress?

1. No, the guidelines prohibit this

2. Yes, but the provider has to request and approve of their involvement

3. Only when it s permissible by the supporting company s policies

The second answer is correct, the presenters said. The pharma person said his company would not want to distribute pure CME from its booths.

Question: Can sales reps distribute CME enduring materials?

1. No, the guidelines prohibit this

2. Yes, but the provider has to request and approve of their involvement

3. Only when it s permissible by the supporting company s policies

The audience went 65 percent for #1, 32 percent for #2, and just 4 percent for #3 on this one. One of the presenters said that while it was permissible in the past, the new Standards for Commercial Support now prohibit this.

An audience member pointed out that Element 4.5 doesn t say that they can t distribute enduring materials, but that providers can t deputize a sales rep as their agent. "If they choose to buy the materials and then distribute them on their own, that s fine. You just can t recruit them to do it for you."

Some comments from the audience: "Since we already vetted the material and it is in compliance, isn t it overly paranoid to worry about who disseminates it?" "Perception could be a problem." "Also, we have to take the FDA rules into account-could this violate their rules on promotional material?"

To comment on this post, click on "comments" below. To receive a weekly update, e-mail Sue.

And some more questions from this Alliance for CME session:

Question: Can sales reps distribute brochures announcing CME activities?

1. No, the guidelines prohibit this

2. Yes, but the provider has to request and approve of their involvement

3. Only when it s permissible by the supporting company s policies

The audience voted 11 percent for the first option, 71 percent for the second, and 18 percent for the third. The pharma presenter said that most, if not all, companies have a policy on this. "We would review every piece our reps are asked to distribute. We do allow brochures, and maybe CME if it s sealed in shrink-wrap and contains no off-label information."

Question: Can brochures be distributed from an exhibit booth during a congress?

1. No, the guidelines prohibit this

2. Yes, but the provider has to request and approve of their involvement

3. Only when it s permissible by the supporting company s policies

The second answer is correct, the presenters said. The pharma person said his company would not want to distribute pure CME from its booths.

Question: Can sales reps distribute CME enduring materials?

1. No, the guidelines prohibit this

2. Yes, but the provider has to request and approve of their involvement

3. Only when it s permissible by the supporting company s policies

The audience went 65 percent for #1, 32 percent for #2, and just 4 percent for #3 on this one. One of the presenters said that while it was permissible in the past, the new Standards for Commercial Support now prohibit this.

An audience member pointed out that Element 4.5 doesn t say that they can t distribute enduring materials, but that providers can t deputize a sales rep as their agent. "If they choose to buy the materials and then distribute them on their own, that s fine. You just can t recruit them to do it for you."

Some comments from the audience: "Since we already vetted the material and it is in compliance, isn t it overly paranoid to worry about who disseminates it?" "Perception could be a problem." "Also, we have to take the FDA rules into account-could this violate their rules on promotional material?"

To comment on this post, click on "comments" below. To receive a weekly update, e-mail Sue.

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