Therapeutic Dose: QbD and PAT: What’s In It for the Little Guy?

Why should mom-and-pop manufacturers invest in process improvement when the risk-reward ratio is against it?

I just spent a terrific week at IFPAC 2009 in Baltimore. It was an impressive show—a number of good papers; in-depth case studies in both pharma and biopharma; an FDA PAT/QbD workshop on Sunday with an open Q&A period that lasted more than  an hour. The stage seemed set for the “Brave New World” of total process understanding and control that we’ve been waiting for and talking about for years.

However, I was not just chatting and communing with my peers, but listening intently, too. I heard a number of comments that seemed at odds with the program’s theme of progress, and whispers that were less than warm and tingly. One person spoke up that very small generic houses were not in the business of making perfect, long-stability products. They were there to push out tablets, capsules, liquids, creams, and lotions that sort of met minimum specifications. Knowing how bogged down the FDA is with inspecting new suppliers in developing countries and, now, with bringing cGMPs to nutraceutical companies, many generics are willing to play the odds, he seemed to be saying.

Play the odds, you say? We all do it when we drive. We see that there are hundreds of cars on the road around us and only a few police cars here and there. If we are all exceeding the speed limit, the chances of any one car being pulled over are quite small. We can get where we are going with, in reality, not much risk of a speeding ticket.

Extending this logic to the industry, the profit margin for a small generic house can be expanded by not investing in scientists, engineers, and equipment needed to perform PAT or QbD. There exist, in almost all countries, manufacturers with only a few employees that may only sell over the internet (to pharmacies, especially) with minimum overhead. The idea is to put the stated amount of drug (label claim) into each tablet or capsule, sell a few thousand bottles or cases and cash the check.

There is no profit in trying to make a product that expires in four years instead of three, so why spend the money? What if the product is sub-par, the “police” catch wind, and a recall is ordered? Perhaps the company can perform the recall; perhaps they will simply declare bankruptcy. There is almost nothing to stop “Smith and Jones, Inc.” from resurrecting itself as “Jones and Smith, Inc.” a year later and carrying on its business. 

The pharmaceutical industry will always have more rules and police than others, but greed is always present. Once any manufacturer starts to bring in money, it becomes an organism with self-preservationist instincts. The profit motive prevails despite all its rhetoric about how its products alleviate pain and suffering.

This ethic applies to all manufacturers, but by the time this ethic works its way down to mom-and-pop generic shops, we are no longer talking about proprietary products and major market share, but selling as many units for the minimal COGS (cost of goods sold). Smith and Jones do not have major QC (or QA) departments, no real R&D, nor the latest processing equipment or lab hardware. The products are likely to be wider in composition (pushing the label claim + 10%) than those of a bigger generic or proprietary house. And, since their lot sizes are generally much smaller, the time product spends in a warehouse is proportionately shorter. Thus, the chance of reaching the expiry date is small.

A lower profile allows the small fish to avoid the nets more adroitly and for longer periods. They have virtually no incentive to take their modest profits and plow them back into the process to make the product “better.” Making matters worse, their drugs’ low costs to patients, especially in down economic times, encourage pharmacists to shop online and buy from this gray market.

What’s in it for them? Why should the little guy invest in process improvement? I left IFPAC kind of glum. The truth can be a buzz-killer.

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