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
1.
Malhotra,
Girish: Calling for change: http://www.cphi.com/documents/129623/1844059/CPhI+Annual+Report+2015+-+Part+I/57d8295a-a73a-444e-b593-c6fccdf00dae
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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