Regulatory Open Forum

What I was referring to is under Volunteer/Opportunities:

https://connect.raps.org/volunteeropportunities/opportunities-list-public

I'm traveling right now with poor connectivity.  My understanding is that the points referenced on this list are RAC points, but if you find out otherwise, I'd be interested (relieved?) to know...

What I was referring to is under Volunteer/Opportunities:

https://connect.raps.org/volunteeropportunities/opportunities-list-public

I'm traveling right now with poor connectivity.  My understanding is that the points referenced on this list are RAC points, but if you find out otherwise, I'd be interested (relieved?) to know...

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

Having been in medical device industry for more than 15 years in various roles in engineering, manufacturing, QA, RA, product development, etc. I believe that Andre, Julie, and Heimo have very good points they are making.

1. RAPS do listen and the world IS changing. Why not RAC?
It is 2017, FDA has made lots of changes throughout the years. EU has changed it's MDR, ASEAN is implementing a lot of stuff, Brazil, etc. RAPS is a great professional organization and I believe that they do care about this discussion about RAC. Pete's presence here certainly makes you think they’re listening to our views. More and more experienced professionals and hiring managers do believe that the RAC has to adapt and change (for example, addition of 2 years’ experience before you can take it).  So why not separation of areas of product expertise.

2. RAC (product specialization here) is complementary to the current scheme which is basically RAC (regional specialization)
I don't believe anyone is saying that the current RAC US or RAC EU disappears. It only makes sense that there would be a product categorization as well to specify RAC Food, RAC Pharma, RAC Biologics, RAC Cosmetics, RAC Medical Devices.

To say that people who completed RAC US and have a RAC after their name also knows international regs doesn't compute.

To say that RAC US holders are regulatory professionals but not people who focus on medical device only, doesn't add up. 

Copying what I heard from someone, do we not agree that working with a professional who has a knowledge 1/2 km wide and 1 km deep is in most cases more useful than those who have knowledge 1 km wide and 1 m deep? For example, a RAC Medical Device says this person knows US regs on medical devices, EU MDR, CMDR, etc. Wouldn't you consider this person a Regulatory Professional? Hiring companies certainly will. Regulatory is a kind of combo science and law discipline which means it can specialize in various areas. So why not RAC.

3. Addition of specializations will not diminish RAC's credibility and increase RAPS' ability to help regulatory professionals all over the world
ASQ have multiple certificates in various fields within Quality. Lawyers have specialization, not just in type of law but in the region or state they practice at. Same with doctors: we have hospitalists, cardiovascular surgeons, pediatrician, etc. Engineering has mechanical, biomedical, electrical, etc.

Why not regulatory? This is already happening whether RAPS members and RAC holders want to acknowledge it or not. Many universities now offer Master of Science in a particular regulatory field, MS RA Food, MS RA drugs and devices, etc. You can actually say that the focus is actually product-specific and regulatory function-specific rather than region-specific like what RAC currently is.

Conclusion
I want us all to empower the profession. This means we need RAPS to help us adapt the RAC for various needs.  I will say that again: RAC should be adopted to various NEEDS of the industries it touches. This will only empower the usefulness of RAPS and help everyone understands that the definition of a regulatory professional should match what the industry needs.

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

Having been in medical device industry for more than 15 years in various roles in engineering, manufacturing, QA, RA, product development, etc. I believe that Andre, Julie, and Heimo have very good points they are making.

1. RAPS do listen and the world IS changing. Why not RAC?
It is 2017, FDA has made lots of changes throughout the years. EU has changed it's MDR, ASEAN is implementing a lot of stuff, Brazil, etc. RAPS is a great professional organization and I believe that they do care about this discussion about RAC. Pete's presence here certainly makes you think they’re listening to our views. More and more experienced professionals and hiring managers do believe that the RAC has to adapt and change (for example, addition of 2 years’ experience before you can take it).  So why not separation of areas of product expertise.

2. RAC (product specialization here) is complementary to the current scheme which is basically RAC (regional specialization)
I don't believe anyone is saying that the current RAC US or RAC EU disappears. It only makes sense that there would be a product categorization as well to specify RAC Food, RAC Pharma, RAC Biologics, RAC Cosmetics, RAC Medical Devices.

To say that people who completed RAC US and have a RAC after their name also knows international regs doesn't compute.

To say that RAC US holders are regulatory professionals but not people who focus on medical device only, doesn't add up. 

Copying what I heard from someone, do we not agree that working with a professional who has a knowledge 1/2 km wide and 1 km deep is in most cases more useful than those who have knowledge 1 km wide and 1 m deep? For example, a RAC Medical Device says this person knows US regs on medical devices, EU MDR, CMDR, etc. Wouldn't you consider this person a Regulatory Professional? Hiring companies certainly will. Regulatory is a kind of combo science and law discipline which means it can specialize in various areas. So why not RAC.

3. Addition of specializations will not diminish RAC's credibility and increase RAPS' ability to help regulatory professionals all over the world
ASQ have multiple certificates in various fields within Quality. Lawyers have specialization, not just in type of law but in the region or state they practice at. Same with doctors: we have hospitalists, cardiovascular surgeons, pediatrician, etc. Engineering has mechanical, biomedical, electrical, etc.

Why not regulatory? This is already happening whether RAPS members and RAC holders want to acknowledge it or not. Many universities now offer Master of Science in a particular regulatory field, MS RA Food, MS RA drugs and devices, etc. You can actually say that the focus is actually product-specific and regulatory function-specific rather than region-specific like what RAC currently is.

Conclusion
I want us all to empower the profession. This means we need RAPS to help us adapt the RAC for various needs.  I will say that again: RAC should be adopted to various NEEDS of the industries it touches. This will only empower the usefulness of RAPS and help everyone understands that the definition of a regulatory professional should match what the industry needs.

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

Having been in medical device industry for more than 15 years in various roles in engineering, manufacturing, QA, RA, product development, etc. I believe that Andre, Julie, and Heimo have very good points they are making.

1. RAPS do listen and the world IS changing. Why not RAC?
It is 2017, FDA has made lots of changes throughout the years. EU has changed it's MDR, ASEAN is implementing a lot of stuff, Brazil, etc. RAPS is a great professional organization and I believe that they do care about this discussion about RAC. Pete's presence here certainly makes you think they’re listening to our views. More and more experienced professionals and hiring managers do believe that the RAC has to adapt and change (for example, addition of 2 years’ experience before you can take it).  So why not separation of areas of product expertise.

2. RAC (product specialization here) is complementary to the current scheme which is basically RAC (regional specialization)
I don't believe anyone is saying that the current RAC US or RAC EU disappears. It only makes sense that there would be a product categorization as well to specify RAC Food, RAC Pharma, RAC Biologics, RAC Cosmetics, RAC Medical Devices.

To say that people who completed RAC US and have a RAC after their name also knows international regs doesn't compute.

To say that RAC US holders are regulatory professionals but not people who focus on medical device only, doesn't add up. 

Copying what I heard from someone, do we not agree that working with a professional who has a knowledge 1/2 km wide and 1 km deep is in most cases more useful than those who have knowledge 1 km wide and 1 m deep? For example, a RAC Medical Device says this person knows US regs on medical devices, EU MDR, CMDR, etc. Wouldn't you consider this person a Regulatory Professional? Hiring companies certainly will. Regulatory is a kind of combo science and law discipline which means it can specialize in various areas. So why not RAC.

3. Addition of specializations will not diminish RAC's credibility and increase RAPS' ability to help regulatory professionals all over the world
ASQ have multiple certificates in various fields within Quality. Lawyers have specialization, not just in type of law but in the region or state they practice at. Same with doctors: we have hospitalists, cardiovascular surgeons, pediatrician, etc. Engineering has mechanical, biomedical, electrical, etc.

Why not regulatory? This is already happening whether RAPS members and RAC holders want to acknowledge it or not. Many universities now offer Master of Science in a particular regulatory field, MS RA Food, MS RA drugs and devices, etc. You can actually say that the focus is actually product-specific and regulatory function-specific rather than region-specific like what RAC currently is.

Conclusion
I want us all to empower the profession. This means we need RAPS to help us adapt the RAC for various needs.  I will say that again: RAC should be adopted to various NEEDS of the industries it touches. This will only empower the usefulness of RAPS and help everyone understands that the definition of a regulatory professional should match what the industry needs.

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

1. There seems to be a lot of "I only want to know what I need to know for my job" tied to what is requested of the RAC. People who say this is trying to highlight the point that they want to specialize just as CURRENTLY RAC is specialized per region (US exam ...). It is a job need, for a changing world, to show their employers they know what they are talking about regardless of what their MS or BS said they have taken because they did study and learn and worked hard in that particular field to become a regulatory professional regardless of background. I've known many good regulatory specialists who has a Bachelors in unrelated X but are wonderful regulatory professionals who could use a credential that matches what they've learned. We are in a new world of self-promotion, independent learning, etc. after all.
2. It was intended to be the Regulatory profession's equivalent of the Professional Engineering certification.  As many here have said, RAC is strictly for fundamentals, so it is NOT a higher level certification like PE. So why do you think there is a push-back to have certifications in specialization in product rather than region? Why not have fundamentals of US, EU, Australia, Japan, global regulations in Food or Medical Devices, etc.?
3. If this type of system was in place [PE], I would be more likely to view the certification as a very important resume item. I agree with you that RAC's reputation will change if it has a higher level version similar to PE. There should be actual submissions of work, years of experience, interview by the 'RAC board', etc. for me to view this to a similar level.
   
4. The more limited the RAC certifcation, the less value it provides as a hiring executive trying to build a top performing organization. Today, the certifications are already limited enough by the geography focus that I have to get a lot of this from interviews and other research (because yes, people can and do become experts at this stuff without any certification at all, just like I have hired some great engineers without a PE). 
   if you read my post, I made the same point that RAC is already being viewed as limited because it's separated per region. And you see that RAC isn't even required if you see a top-performing person who have learned and became an expert without any certification at all. So why limit it further? why only look at RAC on a regional basis? Andre and other folks here is NOT asking for specialty in drug regulation within EU only. They are actually talking about for example, Drug regulation in US, EU, Canada, Australia, etc. How is that any different than someone saying I know drugs, medical devices, and biologics in US only? How is that logic any different? If you're working for a medical device company, that company would probably (I know I do when I hire them) want someone who specializes in medical device and knows how to get the product through globally rather than only know US regulations. The separation is no different from a doctor specializing in cardiology or a lawyer specializing in criminal law. They are still doctors, they are still lawyers.  People who specialize in drugs for multiple regional regulations is still a regulatory professional just as much as someone who specialize in US regulations of medical products.
5. As a side note, it is amazing how much I have used the info I learned on generic drug requirements in order to get my RAC. See #4 where a statement was made regarding people becoming experts without any certifications at all. I love reading and I know other regulations in other areas beyond healthcare products. To give you an idea of what type of person I am, I read several encyclopedia books that my grandmother owned as an 8 year old child for fun; she's a doctor so she encouraged it. I understand the thirst for knowledge. Most medical device courses do tackle combo products and same with drugs. In the US, IVDs and combo products are part of the medical device reg framework. So that should be included in the RAC exam for Medical Devices.

Having been in medical device industry for more than 15 years in various roles in engineering, manufacturing, QA, RA, product development, etc. I believe that Andre, Julie, and Heimo have very good points they are making.

1. RAPS do listen and the world IS changing. Why not RAC?
It is 2017, FDA has made lots of changes throughout the years. EU has changed it's MDR, ASEAN is implementing a lot of stuff, Brazil, etc. RAPS is a great professional organization and I believe that they do care about this discussion about RAC. Pete's presence here certainly makes you think they’re listening to our views. More and more experienced professionals and hiring managers do believe that the RAC has to adapt and change (for example, addition of 2 years’ experience before you can take it).  So why not separation of areas of product expertise.

2. RAC (product specialization here) is complementary to the current scheme which is basically RAC (regional specialization)
I don't believe anyone is saying that the current RAC US or RAC EU disappears. It only makes sense that there would be a product categorization as well to specify RAC Food, RAC Pharma, RAC Biologics, RAC Cosmetics, RAC Medical Devices.

To say that people who completed RAC US and have a RAC after their name also knows international regs doesn't compute.

To say that RAC US holders are regulatory professionals but not people who focus on medical device only, doesn't add up. 

Copying what I heard from someone, do we not agree that working with a professional who has a knowledge 1/2 km wide and 1 km deep is in most cases more useful than those who have knowledge 1 km wide and 1 m deep? For example, a RAC Medical Device says this person knows US regs on medical devices, EU MDR, CMDR, etc. Wouldn't you consider this person a Regulatory Professional? Hiring companies certainly will. Regulatory is a kind of combo science and law discipline which means it can specialize in various areas. So why not RAC.

3. Addition of specializations will not diminish RAC's credibility and increase RAPS' ability to help regulatory professionals all over the world
ASQ have multiple certificates in various fields within Quality. Lawyers have specialization, not just in type of law but in the region or state they practice at. Same with doctors: we have hospitalists, cardiovascular surgeons, pediatrician, etc. Engineering has mechanical, biomedical, electrical, etc.

Why not regulatory? This is already happening whether RAPS members and RAC holders want to acknowledge it or not. Many universities now offer Master of Science in a particular regulatory field, MS RA Food, MS RA drugs and devices, etc. You can actually say that the focus is actually product-specific and regulatory function-specific rather than region-specific like what RAC currently is.

Conclusion
I want us all to empower the profession. This means we need RAPS to help us adapt the RAC for various needs.  I will say that again: RAC should be adopted to various NEEDS of the industries it touches. This will only empower the usefulness of RAPS and help everyone understands that the definition of a regulatory professional should match what the industry needs.

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

Having been in medical device industry for more than 15 years in various roles in engineering, manufacturing, QA, RA, product development, etc. I believe that Andre, Julie, and Heimo have very good points they are making.

1. RAPS do listen and the world IS changing. Why not RAC?
It is 2017, FDA has made lots of changes throughout the years. EU has changed it's MDR, ASEAN is implementing a lot of stuff, Brazil, etc. RAPS is a great professional organization and I believe that they do care about this discussion about RAC. Pete's presence here certainly makes you think they’re listening to our views. More and more experienced professionals and hiring managers do believe that the RAC has to adapt and change (for example, addition of 2 years’ experience before you can take it).  So why not separation of areas of product expertise.

2. RAC (product specialization here) is complementary to the current scheme which is basically RAC (regional specialization)
I don't believe anyone is saying that the current RAC US or RAC EU disappears. It only makes sense that there would be a product categorization as well to specify RAC Food, RAC Pharma, RAC Biologics, RAC Cosmetics, RAC Medical Devices.

To say that people who completed RAC US and have a RAC after their name also knows international regs doesn't compute.

To say that RAC US holders are regulatory professionals but not people who focus on medical device only, doesn't add up. 

Copying what I heard from someone, do we not agree that working with a professional who has a knowledge 1/2 km wide and 1 km deep is in most cases more useful than those who have knowledge 1 km wide and 1 m deep? For example, a RAC Medical Device says this person knows US regs on medical devices, EU MDR, CMDR, etc. Wouldn't you consider this person a Regulatory Professional? Hiring companies certainly will. Regulatory is a kind of combo science and law discipline which means it can specialize in various areas. So why not RAC.

3. Addition of specializations will not diminish RAC's credibility and increase RAPS' ability to help regulatory professionals all over the world
ASQ have multiple certificates in various fields within Quality. Lawyers have specialization, not just in type of law but in the region or state they practice at. Same with doctors: we have hospitalists, cardiovascular surgeons, pediatrician, etc. Engineering has mechanical, biomedical, electrical, etc.

Why not regulatory? This is already happening whether RAPS members and RAC holders want to acknowledge it or not. Many universities now offer Master of Science in a particular regulatory field, MS RA Food, MS RA drugs and devices, etc. You can actually say that the focus is actually product-specific and regulatory function-specific rather than region-specific like what RAC currently is.

Conclusion
I want us all to empower the profession. This means we need RAPS to help us adapt the RAC for various needs.  I will say that again: RAC should be adopted to various NEEDS of the industries it touches. This will only empower the usefulness of RAPS and help everyone understands that the definition of a regulatory professional should match what the industry needs.

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

Having been in medical device industry for more than 15 years in various roles in engineering, manufacturing, QA, RA, product development, etc. I believe that Andre, Julie, and Heimo have very good points they are making.

1. RAPS do listen and the world IS changing. Why not RAC?
It is 2017, FDA has made lots of changes throughout the years. EU has changed it's MDR, ASEAN is implementing a lot of stuff, Brazil, etc. RAPS is a great professional organization and I believe that they do care about this discussion about RAC. Pete's presence here certainly makes you think they’re listening to our views. More and more experienced professionals and hiring managers do believe that the RAC has to adapt and change (for example, addition of 2 years’ experience before you can take it).  So why not separation of areas of product expertise.

2. RAC (product specialization here) is complementary to the current scheme which is basically RAC (regional specialization)
I don't believe anyone is saying that the current RAC US or RAC EU disappears. It only makes sense that there would be a product categorization as well to specify RAC Food, RAC Pharma, RAC Biologics, RAC Cosmetics, RAC Medical Devices.

To say that people who completed RAC US and have a RAC after their name also knows international regs doesn't compute.

To say that RAC US holders are regulatory professionals but not people who focus on medical device only, doesn't add up. 

Copying what I heard from someone, do we not agree that working with a professional who has a knowledge 1/2 km wide and 1 km deep is in most cases more useful than those who have knowledge 1 km wide and 1 m deep? For example, a RAC Medical Device says this person knows US regs on medical devices, EU MDR, CMDR, etc. Wouldn't you consider this person a Regulatory Professional? Hiring companies certainly will. Regulatory is a kind of combo science and law discipline which means it can specialize in various areas. So why not RAC.

3. Addition of specializations will not diminish RAC's credibility and increase RAPS' ability to help regulatory professionals all over the world
ASQ have multiple certificates in various fields within Quality. Lawyers have specialization, not just in type of law but in the region or state they practice at. Same with doctors: we have hospitalists, cardiovascular surgeons, pediatrician, etc. Engineering has mechanical, biomedical, electrical, etc.

Why not regulatory? This is already happening whether RAPS members and RAC holders want to acknowledge it or not. Many universities now offer Master of Science in a particular regulatory field, MS RA Food, MS RA drugs and devices, etc. You can actually say that the focus is actually product-specific and regulatory function-specific rather than region-specific like what RAC currently is.

Conclusion
I want us all to empower the profession. This means we need RAPS to help us adapt the RAC for various needs.  I will say that again: RAC should be adopted to various NEEDS of the industries it touches. This will only empower the usefulness of RAPS and help everyone understands that the definition of a regulatory professional should match what the industry needs.

• Every product type uses the concept of grandfathering, from new dietary agreements in food, substantial equivalence in devices and tobacco, and monographs in drugs. 
• More products trigger user fees and that will only increase across product lines.
• Safety and efficacy evaluations and comparative studies aren't limited to your drug, since devices and dietary supplements may also provide competing, adjunct, or confounding factors; and they can compete with your product, legally and illegally.
• You need to know jurisdictional issues, which cross product lines.
• You need to know what other agencies are doing in the field for all product types: is FTC treating OTC or dietary supplement claims more stringently than FDA can treat your drug claim? How about HHS OIG's corporate integrity agreements?
• Pilots in one FDA center are often reintegrated into other centers; for example User Fees in CDER are now charged in CTP, and CDRH, and by all accounts, coming to CFSAN. "Humanitarian" devices are now "orphans" in CDER.

I'm not sure how well "hidden" this agenda might be, but of course the cost of what one is selling and the amount the market is willing to pay for it is always a key determinant.

I myself don't know how much the "base" cost of any exam might be, or how much narrowing or broadening the scope of the exam (which could be different when one considers broadening the content versus increasing the number of questions) might reduce or increase the total cost of a particular exam.  RAPS is constrained in its options by this reality, but it's also true that sometimes some creative thinking can figure out a way to reach a goal within a challenging set of constraints.

"If you want to have all RACs for the US, you would have to pay for $435 x 4 (e.g., four sub-divisions) instead of $435."  True.  It's also true that, right now, if you want to have all the RACs for pharma or all the RACs for medical devices, you have to pay $435 x 4 (e.g., four jurisdictional exams).  I think there are far more RA professionals whose careers would benefit from the latter than the former, especially the younger ones.