Rights of the government

[wufan]

I have mentioned previously on this fine forum that I work at a pharmaceutical company subject to government regulation. Currently we are undergoing joint inspection from Canada and the EU. Today, I was notified that I was responsible for two observations (legal term for non-compliance):

The first observation is that our instruments create records on non scientific data. The act that creates the record is necessary, but is not impactful in anyway. We failed to recognize and review this record, as is required by the regulation. I have no idea why this is a regulation, but the US, EU, and Canada have all agreed that it is required. For this, I recognize that I am at fault.

The second observation is that we have not hired an independent reviewer of our electronic systems. This is not required by any regulation or contract with any government, however it is in the verbiage of a proposed draft guidance that has been put forth by the EU, Canada, US, and Australia. This really bothers me. How is it that a government gets to draft a proposed legal document and then hold parties, that were previously permitted contract, to the standard of that contract without warning or due process?

I am wholly opposed to this type of oppression by government agencies, yet I will submit to it as this is the stance that the industry has agreed to. I'm not sure what to make of this.

[SB Shock]

I have mentioned previously on this fine forum that I work at a pharmaceutical company subject to government regulation. Currently we are undergoing joint inspection from Canada and the EU. Today, I was notified that I was responsible for two observations (legal term for non-compliance):

The first observation is that our instruments create records on non scientific data. The act that creates the record is necessary, but is not impactful in anyway. We failed to recognize and review this record, as is required by the regulation. I have no idea why this is a regulation, but the US, EU, and Canada have all agreed that it is required. For this, I recognize that I am at fault.

The second observation is that we have not hired an independent reviewer of our electronic systems. This is not required by any regulation or contract with any government, however it is in the verbiage of a proposed draft guidance that has been put forth by the EU, Canada, US, and Australia. This really bothers me. How is it that a government gets to draft a proposed legal document and then hold parties, that were previously permitted contract, to the standard of that contract without warning or due process?

I am wholly opposed to this type of oppression by government agencies, yet I will submit to it as this is the stance that the industry has agreed to. I'm not sure what to make of this.

I believe it is done using what the government calls ADMINISTRATIVE PROCEDURE ACT. They (the government creates NPRM (notice of proposed rule making). Even though it is "proposed" the regulators can (and will) make you comply. We see this all the time in the aviation manufacturing with the FAA and EASA (European equivalent of FAA).

[BOBB]

Government can act as a referee, safety monitor, create a level playing field in areas where consumers have little information. Unfortunately, the nature of bureaucracy is to serve itself. We need government monitoring to ensure safety and protect your business from fraudulent competitors and patent copiers. We don't need them serving their own interests.

[Play Angry]

I have mentioned previously on this fine forum that I work at a pharmaceutical company subject to government regulation. Currently we are undergoing joint inspection from Canada and the EU. Today, I was notified that I was responsible for two observations (legal term for non-compliance):

The first observation is that our instruments create records on non scientific data. The act that creates the record is necessary, but is not impactful in anyway. We failed to recognize and review this record, as is required by the regulation. I have no idea why this is a regulation, but the US, EU, and Canada have all agreed that it is required. For this, I recognize that I am at fault.

The second observation is that we have not hired an independent reviewer of our electronic systems. This is not required by any regulation or contract with any government, however it is in the verbiage of a proposed draft guidance that has been put forth by the EU, Canada, US, and Australia. This really bothers me. How is it that a government gets to draft a proposed legal document and then hold parties, that were previously permitted contract, to the standard of that contract without warning or due process?

I am wholly opposed to this type of oppression by government agencies, yet I will submit to it as this is the stance that the industry has agreed to. I'm not sure what to make of this.

Was there a penalty imposed now for non-compliance to the proposed guidance? If not and they gave you a reasonable period to "cure" in anticipation of the effective date of the regulation's implementation, I don't really get why you'd need due process. The cost of compliance is your only damages, and you now have notice of the change (in addition to the public comment period which is deemed constructive notice as SB notes above).

If they fined you for non-compliance (and not just a threat of a future fine if you don't cure) and the regulation has not been implemented, then that is a different story.

[Kung Wu]

I have mentioned previously on this fine forum that I work at a pharmaceutical company subject to government regulation. Currently we are undergoing joint inspection from Canada and the EU. Today, I was notified that I was responsible for two observations (legal term for non-compliance):

The first observation is that our instruments create records on non scientific data. The act that creates the record is necessary, but is not impactful in anyway. We failed to recognize and review this record, as is required by the regulation. I have no idea why this is a regulation, but the US, EU, and Canada have all agreed that it is required. For this, I recognize that I am at fault.

The second observation is that we have not hired an independent reviewer of our electronic systems. This is not required by any regulation or contract with any government, however it is in the verbiage of a proposed draft guidance that has been put forth by the EU, Canada, US, and Australia. This really bothers me. How is it that a government gets to draft a proposed legal document and then hold parties, that were previously permitted contract, to the standard of that contract without warning or due process?

I am wholly opposed to this type of oppression by government agencies, yet I will submit to it as this is the stance that the industry has agreed to. I'm not sure what to make of this.

Make sure to check if the first observation has been relaxed in the proposed draft guidance!

[Aargh]

This is an example of how we get government regulations. Somebody or some entity screws up and damage is done that goes beyond the entity that had the problem. Once damage spreads , an evaluation is made whether this type of damage can be tolerated if it occurs again.

If the conclusion is that the public would be better served if the damage were not repeated, then a new regualtion is created and enforced among all similar entities, even though those entities have not had the problem being protected against.

Then there is much wailing and gnashing of teeth because of the big government coming in and micro-managing private entities. Sometimes bureaucracies will "manufacture" problems and create ludicrous regulations, but often the regs are made because of potential damage to the public.

I can see where not having an outisde consultant or agency evaluating a pharmaceutical's electronic systems could pose a problem that would extend beyond the confines of the company being required to have the outside agency. Industrial espionage, or even a rogue insider could create some problems. If there are electronic controls that configure the components of pharmaceuticals, that would be a great target for terrorist groups or enemies of the state to hack.

[wufan]

What I do is verify that what we did was correct (I.e. Quality control where I test a sample to make sure it is 100% pure). That is done by my employees and an independent second verifier. Observation 1 is that if a record is created, then it must be reviewed. These records have nothing to do with the product, so there is no impact. Observation 2 is that our third verifier of the electronic audit trail is a supervisor within the org. They believe it should be outside of quality and outside of manufacturing and reside with an independent group. Because three independent people might conspire to fraud. It could happen, but it's not very likely, and even if they did, my entire organization is an independent verifier of the other three organizations (manufacturing and validations). Validations has an independent review. Basically you need 6-10 people from 4 different organizations to conspire to lie about a known working process that has already been gov reviewed. The gov is proposing that a 5th organization is required to prevent potential fraud.

The penalty for the non-compliance is an import ban on all non-medically necessary medications.

There is no potential data hacking that could occur for these observations.

[SB Shock]

What I do is verify that what we did was correct (I.e. Quality control where I test a sample to make sure it is 100% pure). That is done by my employees and an independent second verifier. Observation 1 is that if a record is created, then it must be reviewed. These records have nothing to do with the product, so there is no impact. Observation 2 is that our third verifier of the electronic audit trail is a supervisor within the org. They believe it should be outside of quality and outside of manufacturing and reside with an independent group. Because three independent people might conspire to fraud. It could happen, but it's not very likely, and even if they did, my entire organization is an independent verifier of the other three organizations (manufacturing and validations). Validations has an independent review. Basically you need 6-10 people from 4 different organizations to conspire to lie about a known working process that has already been gov reviewed. The gov is proposing that a 5th organization is required to prevent potential fraud.

The penalty for the non-compliance is an import ban on all non-medically necessary medications.

There is no potential data hacking that could occur for these observations.

It also a way that countries protect their markets.

[Rocky Mountain Shock]

This is an example of how we get government regulations. Somebody or some entity screws up and damage is done that goes beyond the entity that had the problem. Once damage spreads , an evaluation is made whether this type of damage can be tolerated if it occurs again.

If the conclusion is that the public would be better served if the damage were not repeated, then a new regualtion is created and enforced among all similar entities, even though those entities have not had the problem being protected against.

Then there is much wailing and gnashing of teeth because of the big government coming in and micro-managing private entities. Sometimes bureaucracies will "manufacture" problems and create ludicrous regulations, but often the regs are made because of potential damage to the public.

I can see where not having an outisde consultant or agency evaluating a pharmaceutical's electronic systems could pose a problem that would extend beyond the confines of the company being required to have the outside agency. Industrial espionage, or even a rogue insider could create some problems. If there are electronic controls that configure the components of pharmaceuticals, that would be a great target for terrorist groups or enemies of the state to hack.

This is actually a pretty good synopsis of the origin of government regulations.

Everyone bitches and moans about regulations and government interference. But comparatively few get as upset about the initial moron who screwed up and caused the government's involvement to begin with.

Government probably is too quick to get involved in many cases, but our ire as a population is too often placed on the government when it should be focused more on the idiots that caused the problem that the government is trying to solve.

[Walker]

It would be interesting to know the amount of regulations born from individuals creating situations that create necessity for regulations/bureaucracies as opposed to regulations and bureaucracies created by politicians in order to be in favor of the highest bidding lobby firm so they can put a stranglehold on the competition.

I'm willing to bet the latter is the more frequent occurrence nowadays. It's amazing that they can hold pharmaceutical companies, or any other for that matter responsible for any regulations that have yet to be enacted when it should be held to what was under contract. I'm convinced that if Uncle Sam wants to bring down the hammer, it can do so to anybody it wants to with the infinite arsenal of laws or regulations in the books. In the crazy event there isn't a law for them to bring the pain, it will be made shortly after.

Anything past the 10 commandments is either redundant or a tool for oppression.

[wufan]

Here's my biased opinion, and it should be noted that I have a very good job because, and only because, of government regulation:

1. Very few times are new regulations put in place because someone screwed up. Most of these policies (the small and regular tweaks to existing policies) are put in place because someone imagined a scenario where this could have been a questionable activity.

2. Most widespread new policies are put in place at the behest of companies/lobyinsts. If I'm a company and I found a great new thing (an autoclave for instance in my business) that costs $10 million dollars, but offers no knew business savings, I lobby the government to require this piece of equipment because it does something slightly safer. Now the autoclaves we've been using, that cost 1/10 that price have been fine for the past 1/4 century, and they offer the same three log reduction as the new model, but the new model requires the operator to enter an ID and password, whereas previously the operator had to write their name and date on a log. So, not safer, but there's an increase in traceability. Cool! Since all of our equipment runs through that autoclave, the new products we manufacture will have to absorb the cost of the new clave.

I wonder why pharmaceuticals are expensive?

[Rocky Mountain Shock]

I wonder why pharmaceuticals are expensive?

The EpiPen dude has a really interesting explanation.

On the other hand, literally anyone who lives outside the United States won't know what you're talking about. Drugs aren't expensive there. Strange...

[wufan]

The EpiPen dude has a really interesting explanation.

On the other hand, literally anyone who lives outside the United States won't know what you're talking about. Drugs aren't expensive there. Strange...

We actually make a competitor to the epi-pen.

[MoValley John]

We actually make a competitor to the epi-pen.

Epinephrine is cheap. Really cheap.