Regulatory Open Forum

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

You might consider asking whether you could hire a former FDA reviewer who is a consultant if they agree with your approach or believe you should be more aggressive. In the past, I have seen that similar opinions have provided support for the regulatory professional's opinion.<o:p></o:p>

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

I'd find an article of one of those 10-year approval delays after years of litigation and share that so they can think about whether it's worth it. Are they willing to go the submission issue presub route before moving to the Ombudsman?

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

It comes down to the credibility of RA group in any company! One cannot just assume that management is always at fault! For example, I have noticed just this week two egregious RA responses/situations! One just this AM, someone said (based on internal RA advise) a sponsor cannot let a study be pursued by an investigator just because the study was originally initiated by the sponsor and with the same investigator who is now willing to pursue the study with his/her own IND. Second, someone said facilities information should be provided based on the IND phase (phase 1, 2, 3) or stage of development. Both were so out of line and absolutely incorrect! So unless we know your history and background or full details as to why your management thinks you are not aggressive enough all the above responses maybe just make you feel good but not really worth it! 

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

There is no assurance from any of the potential routes.

1. Pushing back: There are several instances of successful dispute resolution, such as when the review division determined that a drug lacked substantive evidence, but the dispute process determined otherwise. Similarly, there are unsuccessful cases.
2. Working with FDA: There are a number of instances in which sponsors have diligently altered the FDA's position by cooperating with them.

There is no such thing as things firing back, in my opinion. The path you take depends on the subject matter at hand. If there is a solid scientific justification, there is nothing to fear about the "pushing back" that has been discussed. It is a formal process available where senior FDA official get involved. I can attest that it is a fair hearing for most part. The suggestions above to get former reviewers with experience in FDA negotiation will help the RA team and the management a route of high probability of success. This is not just someone who has spent time at FDA but has been part of negotations on both sides of the aisle.

------------------------------
Pravin Jadhav
CEO, Vivpro
Lansdale PA
United States

Original Message:
Sent: 06-Jun-2023 17:02
From: Anonymous Member
Subject: Pushing back on FDA

This message was posted by a user wishing to remain anonymous

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

Above all else, it is their ball and their playground, so you have to play by their rules.

There is no assurance from any of the potential routes.

1. Pushing back: There are several instances of successful dispute resolution, such as when the review division determined that a drug lacked substantive evidence, but the dispute process determined otherwise. Similarly, there are unsuccessful cases.
2. Working with FDA: There are a number of instances in which sponsors have diligently altered the FDA's position by cooperating with them.

There is no such thing as things firing back, in my opinion. The path you take depends on the subject matter at hand. If there is a solid scientific justification, there is nothing to fear about the "pushing back" that has been discussed. It is a formal process available where senior FDA official get involved. I can attest that it is a fair hearing for most part. The suggestions above to get former reviewers with experience in FDA negotiation will help the RA team and the management a route of high probability of success. This is not just someone who has spent time at FDA but has been part of negotations on both sides of the aisle.

------------------------------
Pravin Jadhav
CEO, Vivpro
Lansdale PA
United States

Original Message:
Sent: 06-Jun-2023 17:02
From: Anonymous Member
Subject: Pushing back on FDA

This message was posted by a user wishing to remain anonymous

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

There is no assurance from any of the potential routes.

1. Pushing back: There are several instances of successful dispute resolution, such as when the review division determined that a drug lacked substantive evidence, but the dispute process determined otherwise. Similarly, there are unsuccessful cases.
2. Working with FDA: There are a number of instances in which sponsors have diligently altered the FDA's position by cooperating with them.

There is no such thing as things firing back, in my opinion. The path you take depends on the subject matter at hand. If there is a solid scientific justification, there is nothing to fear about the "pushing back" that has been discussed. It is a formal process available where senior FDA official get involved. I can attest that it is a fair hearing for most part. The suggestions above to get former reviewers with experience in FDA negotiation will help the RA team and the management a route of high probability of success. This is not just someone who has spent time at FDA but has been part of negotations on both sides of the aisle.

------------------------------
Pravin Jadhav
CEO, Vivpro
Lansdale PA
United States

Original Message:
Sent: 06-Jun-2023 17:02
From: Anonymous Member
Subject: Pushing back on FDA

This message was posted by a user wishing to remain anonymous

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.

How would you respond to criticism from executives outside RA, and without direct experience in RA, saying that your RA team is not aggressive enough?

As background, FDA is asking for much more data from our company then they did from another company with a similar (but not the same) product.  Like, data that will take a few years to collect.  The products are in fact different--in my view the difference doesn't fully justify the huge amount of data FDA wants, but an objective outsider wouldn't immediately say FDA was being absurd to ask for it.

We have been negotiating with the review team.

However, other teams have lost patience with RA.  They say that we should take a more aggressive posture than negotiation.  We should "lawyer up," demand a level playing field, contact the Ombudsman, etc. etc. and go into battle.  

How would you respond?  I don't think this route would be productive (do you agree?) but I've never tried it.

I feel it would be a huge waste of time and money and would backfire, but I need to give a concrete explanation of why.

I've already tried to explain (with no success) that since the issue is a scientific difference and not a legal or procedural one, even if we "lawyered up" ultimately the issue would go back to the review team.  So we would have wasted a lot of time and money and gone in a circle, antagonizing our review division in the process.

Advice is welcome.