All opinions are my own.

Thursday, November 19, 2015

Is FDA Rule 21CFR314.70 a Case of “Shackled Freedom” for Pharmaceutical Manufacturing?

FDA rule CFR314.70 is an interesting rule. I believe if the pharmaceutical industry wants to produce quality drugs with minimal or no in-process testing, this rule has to change. I have presented my perspective (1,2,3).

This rule is of significant value as it can improve profitability, expand the patient base by making drugs affordable and get the companies out of the rut of repeated analysis of samples all along the manufacturing processes. However, the rule needs to be simplified.

If done and implemented commercial processes can be improved and best of the chemical engineering and chemistry practices be incorporated during the patent life of the branded products and also for generic products. “Continuous improvement” would become part of the pharma lifestyle. Fundamentals of engineering and science will lead development and commercialization of excellent processes. They will produce quality products. Science would make glorified acronyms (QbA, PAT and QbD) history.

Rule as it exists suggests that companies can change the approved processes but have to share with the regulators everything like what, how, when and where the improvements will be done. This, I would call is regulatory interference and is a deterrent. This I call is “shackled freedom”, companies can innovate but the regulatory red tape becomes bottleneck for innovation. Most likely in the current scenario companies would not do any process improvements. Companies do not have any incentive to improve their practices as profits and their customer base (who-so-ever can afford) are assured even with inefficient processes/methods. Patient will pay to extend life.

For “continuous improvements” and manufacturing technology innovation companies need complete freedom. My recommendation to the rule makers is that the companies be allowed to do so with the stipulation that the produced product has to meet efficacy and performance of the already approved product i.e. bioequivalence has to be assured and demonstrated if desired by the regulators. A trust has to be built between the companies and regulators.

For regulators to give away the suggested freedom to the companies would be like giving away their kingdom, a difficult choice. Since quality of the drugs is paramount, companies will have to give something also to the regulators and that would be if the product quality is not met, the producing operation is shut down, no questions asked. Legal interference could create issues for this give and take.

Who will win?

If suggested is adopted process of “continuous improvement” will set in and it could lead to much needed competition in pharma. Winners will be patients (through affordable drugs) and companies with higher profits (through better technologies). Regulators will regulate. I believe carrot and stick approach will help us all win. Pharma will be able to capitalize on an unprecedented opportunity that has never been offered to any industry i.e. increase their customer base by as much as billion or more. It will be a win-win.  

Girish Malhotra, PE
EPCOT International

2.     Malhotra, Girish: Process of Continuous Improvement and Pharmaceuticals: http://pharmachemicalscoatings.blogspot.com/2009/06/process-of-continuous-improvement-and.html

3.     Malhotra, Girish: Impact of 21CFR 314.70 on The Life of a Pharmaceutical Manufacturing Process: http://pharmachemicalscoatings.blogspot.com/2015/08/impact-of-21cfr-314670-on-life-of.html

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