Reasons for Regulations

I have resisted writing about the issue with the compounding pharmacy in Massachusetts for a couple weeks as I didn’t want to pile on.  I am not a legal or a regulatory expert so I will not try to assign absolute blame at this early stage.  Take a look at this piece in the Chicago Tribune and note that things do seem totally out of control.  Those that took any product from this compounding center must feel extremely vulnerable and confused as to what went wrong.  It seems that the answer may be in the lack of regulatory oversight by the FDA or the ineffectiveness of the internal regulations and tests the company had in place to protect their customers.

Those of us in the pharmaceutical industry often complain about the constraints put on us by the FDA and others but perhaps we should view it as a huge point of strength at times like this.  As customers are turning to overseas pharmacies, compounding centers and Internet pharmacies for economic reasons or for products not sold by the industry it is important that the risks are clearly seen.  This disaster at the compounding center may be as vivid a message as anything the industry could have said.  Because our industry is super-regulated it may instill a sense of trust and confidence in our patients and perhaps this incident may help the public understand at least one reason why our drugs costs what they do.

There are numerous other reasons we should see regulation in our industry as a friend rather than a barrier to success.  Start with the obvious patent regulations that give us the security of some amount of time before our products can be copied.  FDA regulations around drug discovery and development give us a blueprint as to how to maneuver our products through the cycle.  Without this guidance there would clearly be chaos.  We complain a lot about the regulations around marketing communications but consider what a problem it would be if competitors could say anything they wanted about their products if the truth was not regulated.  I for one get extremely upset when non-pharmaceutical companies are all over the radio and TV making implied claims about their products that compete with regulated pharmaceuticals.  I could go on and on, but even though we often complain about too much regulation we should clearly see the value of the right amount of regulation.

For those of us who work in the industry the regulatory restraints must give us at least some solace.  The intense review process both before a product is approved and the constraints put in place for manufacturing and monitoring marketed products allow us to feel a sense of confidence in the safety and efficacy of the products we market.  The regulations provide a sense of fairness within the industry as everyone must operate with the same set of rules.  Regulations provide the stability that allows us to prosper without worrying about preventable disasters.

For the pharmaceutical professional the challenge is to move away from complaining about the regulations to perhaps having a greater understanding of them.  If everyone recognized the “why” we do things the way we do then attention could turn to being more effective within the constraints.  Perhaps the image we should think about is that of the professional golfer who so respects the game that he or she would call a penalty on themselves and perhaps even lose a tournament when they accidentally make their ball move before swinging.  The rules mean something to them even if it is only when playing a game.  The compounding company’s problem shows us we are playing much more than a game in the pharmaceutical world.

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