Compare FDA to FAA compliance? Six Questions

[Wes Bucey]

I need some help in creating a research project to compare rates of compliance/noncompliance for organizations subject to the regulations of two different US government agencies.

My initial queries:

1. Can I get I get sufficient data about enforcement action by either/both of these two agencies against the organizations they regulate?
2. Can I set up a statistical inquiry which will accommodate difference in numbers of regulated organizations?
3. Is there a fundamental difference between the outputs of the regulated organizations which would make comparison meaningless? (i.e. FDA products directly affect end consumers; FAA products indirectly affect consumers)
4. Is there a perception difference on part of media and public which affects the enforcement tactics of the agencies? ("the squeaky wheel gets grease")
5. Is there a difference in response time between complaint and action by agency?
6. Is there a trend that increased (publicized) enforcement on some organizations increases voluntary compliance by remaining regulated organizations?

This is just a nebulous idea at present. It may develop into an article or even a book. (Alternately, it could go in the closet with my leisure suit and Nehru jackets from 1970!)

[Al Rosen]

Originally Posted by Wes Bucey

I need some help in creating a research project to compare rates of compliance/noncompliance for organizations subject to the regulations of two different US government agencies.

My initial queries:

1. Can I get I get sufficient data about enforcement action by either/both of these two agencies against the organizations they regulate?
2. Can I set up a statistical inquiry which will accommodate difference in numbers of regulated organizations?
3. Is there a fundamental difference between the outputs of the regulated organizations which would make comparison meaningless? (i.e. FDA products directly affect end consumers; FAA products indirectly affect consumers)
4. Is there a perception difference on part of media and public which affects the enforcement tactics of the agencies? ("the squeaky wheel gets grease")
5. Is there a difference in response time between complaint and action by agency?
6. Is there a trend that increased (publicized) enforcement on some organizations increases voluntary compliance by remaining regulated organizations?

This is just a nebulous idea at present. It may develop into an article or even a book. (Alternately, it could go in the closet with my leisure suit and Nehru jackets from 1970!)

Wes:

I've had experience with both agencies. The FDA uses more intimidating tactics than the FAA. Probably because part of the FAA's charter is to promote aviation as well as regulate, while the FDA is strictly a regulatory agency.

I believe that the FDA regulates more organizations than the FAA. I don't have the numbers but they are available from their respective web sites. You might add up all the FAA certificate holders (PAH, PMA, Repair Station etc.) and compare to the more extensive FDA establishment registrations, including food, drugs, cosmetics, medical devices, biologics, animal feed & drugs as well as radiation emitting devices (cell phones, lasers etc.).

You might research the Federal register for enforcement in the FAA area. The FDA publicizes its enforcement on its web site (part of their tactics).

BTW it is unusual for the FDA not to write anything on a 483 (inspectional observations). Too many items or not responding with timely C/A gets you a Warning Letter. Not responding to the Warning Letter goes to the next level etc.

Some web sites to start with on your project:

http://www.gpoaccess.gov/fr/index.html

http://www.faa.gov/

http://www.fda.gov/default.htm

http://www.fda.gov/cdrh/comp/estregls.html#file1

http://www.fda.gov/foi/warning.htm

http://www.fda.gov/opacom/Enforce.html

[Wes Bucey]

Originally Posted by Al Rosen

Wes:

I've had experience with both agencies. The FDA uses more intimidating tactics than the FAA. Probably because part of the FAA's charter is to promote aviation as well as regulate, while the FDA is strictly a regulatory agency.

I believe that the FDA regulates more organizations than the FAA. I don't have the numbers but they are available from their respective web sites. You might add up all the FAA certificate holders (PAH, PMA, Repair Station etc.) and compare to the more extensive FDA establishment registrations, including food, drugs, cosmetics, medical devices, biologics, animal feed & drugs as well as radiation emitting devices (cell phones, lasers etc.).

You might research the Federal register for enforcement in the FAA area. The FDA publicizes its enforcement on its web site (part of their tactics).

BTW it is unusual for the FDA not to write anything on a 483 (inspectional observations). Too many items or not responding with timely C/A gets you a Warning Letter. Not responding to the Warning Letter goes to the next level etc.

Some web sites to start with on your project:

http://www.gpoaccess.gov/fr/index.html

http://www.faa.gov/

http://www.fda.gov/default.htm

http://www.fda.gov/cdrh/comp/estregls.html#file1

http://www.fda.gov/foi/warning.htm

http://www.fda.gov/opacom/Enforce.html

Thanks, Al.
I'm in the final throes of preparing for a presentation Saturday on another topic (small audience - less than 50, but too knowledgeable to try to "phone it in")

I'll come back to this Sunday or Monday.

This is a good start for Query #1. Anyone have ideas on the remaining queries?

[Wes Bucey]

Originally Posted by Wes Bucey

Thanks, Al.
I'm in the final throes of preparing for a presentation Saturday on another topic (small audience - less than 50, but too knowledgeable to try to "phone it in")

I'll come back to this Sunday or Monday.

This is a good start for Query #1. Anyone have ideas on the remaining queries?

I'm B-A-A-A-C-K (as the poltergeists are wont to say )

So - it's the weekend and everybody's burned out, huh?

For an "honorarium," I received a plaque, a trophy, and a stopwatch. Do you think the stopwatch was a not-so-subtle hint I talked too long?

I fielded 15 questions during the presentation and included a recap of the questions and answers during my summing up. They scheduled me for 50 minutes - I was on-stage, including applause, for 56 minutes.

For this FAA-FDA line of research, I had six basic queries:
My initial queries:

1. Can I get I get sufficient data about enforcement action by either/both of these two agencies against the organizations they regulate?
2. Can I set up a statistical inquiry which will accommodate difference in numbers of regulated organizations?
3. Is there a fundamental difference between the outputs of the regulated organizations which would make comparison meaningless? (i.e. FDA products directly affect end consumers; FAA products indirectly affect consumers)
4. Is there a perception difference on part of media and public which affects the enforcement tactics of the agencies? ("the squeaky wheel gets grease")
5. Is there a difference in response time between complaint and action by agency?
6. Is there a trend that increased (publicized) enforcement on some organizations increases voluntary compliance by remaining regulated organizations?

Anyone have an opinion on the queries? Are they workable/viable? Is there anyone who would give a rat's a$$ on the results? (I fully recognize that stuff that piques my curiosity may not stir anyone else's.)

I've answered a lot of questions for others - I hope I can get some good feedback from my colleagues in the Cove on these questions.