In an article by Wayne Heilman of the Colorado Springs Gazette, I learned of a US FDA action against contract drug manufacturer Provident Pharmaceuticals. The company has been cited for good manufacturing practices (GMP) violations as well as the manufacture of unapproved drugs. The GMP violations are of a magnitude that FDA requested that Provident hire a GMP training consultant to bring the facility up to snuff.
However, Heilman seized upon an interesting side light in the warning: the names of the unapproved drugs apparently made by the company are missing from the detailed warning letter.
By unapproved drugs, FDA means drugs whose safety and efficacy has not been formally investigated under modern criteria. Some of these agents are those which the average person might say, “Really? That was never approved? You’re kidding, right?”
I suspect this is an innocent omission – I hypothesize that Provident wasn’t doing anything nefarious – because FDA has been widely aggressive in acting against companies marketing such old drugs, a topic that deserves its own post. In the meantime, the reader may care to visit this Unapproved Drugs site at fda.gov.
A good example is the expectorant, guaifenesin, a natural product isolated for trees of the Guaiacum genus. This compound, a racemic mixture actually, was approved by FDA in 1952 to increase the volume and reduce the viscosity of respiratory secretions. However, it was never formally approved after the 1962 legislation that gave the US most of its current guidelines for preclinical and clinical drug testing.
When FDA began its current enforcement campaign against unapproved drug manufacturers, Reckitt Benckiser seized upon guaifenesin being an unapproved drug, brought it up to modern standards, and now has a top-selling product with Mucinex, accompanied by those animated mucus blob characters that either charm or repulse.
I hope that things get straightened out for Provident, a company with 44 employees two years ago that has now grown to 70. They have largely been a success story for the southern end of the Boulder-Denver-Colorado Springs biotechnology corridor, an area that was featured in 2007 as a technology hub by Site Selection magazine.
Provident is led by Dr Brian Crook, a Colorado State University BS and DVM graduate who cuts his teeth in pharma with Merck and Centocor. (Although he did unwisely introduce himself in this article as, “A Crook who sells drugs” – bad branding my social media peeps might say.)
I don’t have any relationship with Dr Crook or any of the companies with which he is or was affiliated. I’m just a big booster of the Colorado Springs area and its educational institutions. The Springs are home to the Biological Sciences Curriculum Study (BSCS), a non-profit organization that develops curricular materials for agencies like NIH or NSF and makes many of them available to teachers free of charge. We featured BSCS here in 2006 and 2008.
The city is also home to Colorado College, a superb, private four-year arts and sciences college where I have had the honor of guest lecturing. Their unique “Block Plan”, taking one intensive course at a time, provides such intensive, experiential, and refreshing collegiate experiences that I’ve known several CU-Boulder and Denver faculty members to send their kids there over Colorado’s flagship university.
Across town, the University of Colorado at Colorado Springs also recently opened a $56 million, 156,000 sq ft science and engineering building on their campus. (UCCS is also home to psychology professor and CU President’s Teaching Scholar, Fred Coolidge, PhD, guitarist in the band Pink Freud.)
So, I hope that this case with Provident comes to some resolution for the best of the company and their Colorado Springs employees. Moreover, I hope that my educator colleagues there might seize upon this episode for a case study of the pharmaceutical industry, FDA regulations, and the history of pharmacology.