Therapeutic Dose: Problems in Pharma? Time to Examine the Rules

Enforcing existing laws is a start.

By Emil W. Ciurczak, Contributing Editor

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As happens so often, seemingly disparate events come together in my mind and resonate. There was the story of the middle-aged woman in the Midwest who pretended to be a teenage boy, cyber-friended a young girl, and drove her to suicide. Our laws didn’t seem to cover that, so she basically went unpunished.

Our crack Congress just went through a “passion play” over the debt ceiling (we are the only major nation to have one, but that is another matter). The vested interests of each district and special interest were ferociously protected (to the detriment of the Republic).

This 21st century Congress was attempting to operate under 18th century rules.

These two disparate occurrences reminded me of the problems we are having in the Pharma world. For a second, let’s jump back to 50 years ago, when the “rules” of the game were put into play. In 1970, the company I worked for synthesized its API in-house, produced tablets in-house, packaged in-house, warehoused in-house, and distributed directly to pharmacies. Other than excipients (we couldn’t grow our own grains for starch or raise cows for lactose), there was no “supply-chain” to speak of. The excipients were purchased from U.S. companies, vetted by the USDA and FDA, so we needed no more than the USP methods for ID and purity.

The world (and manufacturers’ inventories) grew. A combination of labor, building, and specialized equipment (blister packaging was just coming in the early 1970s to replace strip-packs) costs encouraged companies to contract with outside firms to package, warehouse, and even synthesize the API and produce the tablets and capsules, and even develop new products. Still there wasn’t much trouble, since the outsourced firms were (then) domestic and, as such, FDA inspected and regulated.

But the world continued to expand. The Soviet threat evaporated and “Red” China (our enemy) became just plain China (our friend); India and Brazil industrialized and we hit a small economic “speed bump” a few years back. To make a long (scary) story short, we now have multi-country, multi-thousand mile supply chains and the Praetorian Guard (read: FDA) has been sent to inspect the prescription drug facilities as well as those for generics and now nutraceuticals. We are left with minimal inspections of our newest “trusted” suppliers. Back to this problem in a moment…

Speaking of antiquated laws, current patent laws date back before Benjamin Franklin! That is fine when you are patenting a lightning rod, but if you have to put your product through rigorous tests for up to ten years (clinical trials) before a penny is taken in (assuming it actually works), seventeen years seems awfully short. This curtailed sales life of a product leads to using USP tests for release so that there is no delay caused by trying more modern methods. It also forces a company to charge ungodly prices to recoup R&D and manufacturing costs and see some profit.

Suppose a tiny change in the patent law allowed a company to not start the clock until, say, the end of the Phase III trials? The pressure to rush a release method would be off (they would have years to play with new techniques). In addition, with five or six more years of protection, prices could be negotiated and a profit still seen.

Of course, one gambit used by Pharma is to synthesize and patent every conceivable isomer of the active to discourage competition. Along with the extended patent time, I would suggest, in the name of even lower prices and more choices, that, if a company patents a moiety and does not do any development in five years, the patent be voided. This would discourage the “dog in the manger” approach of boxing out competition and allow more products to be on the market, giving doctors more choices and patients (possibly) lower drug costs.

Going back to the supply-chain and other problems, the solution is simple, yet difficult: update laws to reflect the realities of the 21st century. That would take logic, courage, and a lot of cooperation . . . oy! However, all these problems will only get worse if we insist on putting band-aids on skin cancer. In the past, I have suggested enforcing existing laws, for a start. Simply tell companies that, in 1, 2, or 3 years, the GMP requirement of testing a “statistically significant” number of dosage forms would be enforced. My estimate is that a 2,500,000 tablet batch could be required to have 25,000 HPLC assays performed. Trust me: there would be such a rush to Process Analytical Technologies (PAT) that the wind created would knock over small trees. Since we cannot always trust people to do the “right thing,” we will need up-to-date laws in place to meet 21st century challenges.

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