Three entities are involved to make above happen. Each has to be on top of its game to provide necessary quality drugs all the times. This might seem to be an easy task but the reality is different. Each has to operate as a well-oiled machine to deliver quality products. There is no financial affiliation.
For simplicity, each entity has to manufacture its products to be a quality product. If the product has to be re-worked for quality product, entity has failed. Many might not like my equivalence of tasks each entity takes to manufacturing. In the manufacture of every product, each entity has to practice sequential steps precisely to produce their products. Same has to happen for filing or manufacture or distribution. Steps have to be precise so that anyone can follow them.
Focus is on drugs (Brand and Generics) that have been approved. Process starts with FDA, HHS, CMS (regulators) simplifying and holding every entity including self, responsible for their products. Instead of explaining shortcomings, I am elaborating expected deliverables (1, 2) and lack thereof for each entity. Road map outlined simplifies processes and lets the companies innovate to improve affordability and improve their profits.
Each entity will vigorously defend their turf, would not want to change the status quo. They will seek legislative interference to make sure such simplification and accountability does not interfere their “cash cows and habit of procrastination” to do the right things. Actually, done right, “road map” will improve product quality, profits and revenues. It will be an excellent example of “Nondestructive Creation” and have far reaching impact.
Regulators & Regulations
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API & Formulations
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PBMs & Allies
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· ANDA filing and approval process (are process design) has to be precisely defined (= manufacturing steps) so any company (operator) follows them will meet cGMP requirements and produce quality products. Filer can get an approval in 90 days or less.
· If FDA instructions cannot be followed and it needs additional information from the filer, it suggests ANDA filing process design is a QbA process and is not a QbD process, as preached by FDA.
· 90-day approval would encourage competition through better technologies and economies of scale. It will also reduce shortages. This should be encouraged and promoted.
· FDA should stop promoting technologies where it has no live/practical experience.
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· Each Manufacturer when files for an ANDA approval, is declaring that if its application is approved, it will abide by what it has been committed (commercial) in its filing. If it cannot, they should inform FDA (regulators) of their excursions outside their commitment.
· If a company is cited (483), it deposits $200,000.00 (refundable). If corrections are not remedied in a verified time and sustained, a second 483 citation, FDA bars the company for FOUR years to export product to USA. Deposit is lost.
· Company’s products can be analyzed for its quality commitment through independent sampling. If product/s are found to be outside their committed quality specifications, company needs to let the regulators and supply chain of their infractions and stop exports to USA.
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· If PBMs and allies distribute products that are tested and do not meet established quality specifications and standards, responsible member has to pay non-refundable $500,000 per incident per drug. This will assure manufacturers and distributors are always producing and selling quality products.
· If drugs are approved by FDA, Drug Formulary should not be necessary. Let the patients and their doctors decide which drugs will serve the need and are affordable. Formulary lists prevent price and quality competition between companies.
· Generic drug manufacturers should be allowed, promoted and encouraged direct sales to patients through approved pharmacies. All will compete on pricing and quality.
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Girish Malhotra, PE
EPCOT International
