From Deseret News archives:
Drug standards hard to swallow
Behind the scenes of those little white (or gray or blue) pills you take so innocently, the Federal Drug Administration and pharmaceutical companies have been at odds for decades over standards that govern the potency, possible contamination and quality of their drugs.
Obviously, companies that don't have good manufacturing practices produce inferior pills. You buy the pills, you take the pills, you're toast. But what constitutes "good"?
In a panel discussion this past week at the Salt Palace Convention Center, where the American Association of Pharmaceutical Scientists is holding its annual meeting, FDA representative Ajaz Hussain cited an example of a drug company manufacturing time-release pellets. A worker was coating the pellets in a pan, but the coating had a tendency to stick to the sides. Every once in a while, the worker would scrape off the built-up coating, which would then be reintroduced into the manufacturing process.
Good practices? No. But what should it be replaced with?
If manufacturers don't measure up to government standards, they face such things as fines of hundreds of millions of dollars, closed operations, confiscated product and other Draconian measures. And that's not even taking into account the fallout: One company that had regulatory problems lost a whopping $18 billion in capitalization.
But here's the problem:
"GMP (good manufacturing practices) has basically been a moving target," said panelist Alan Smith, a pharmaceutical quality and technology consultant. "You can begin to see the confusion globally of what constitutes GMP."
"Many people say, 'I've been in the industry 20 years, and I've never had to do this (particular requirement) before,' " said Joseph Mastronardy, who moderated the panel discussion. " 'It doesn't make sense.' Well, it's not about sense. It's about science."
The research and development sections of drug companies are staffed by boatloads of doctorates and Mensa members, but often their carefully crafted processes don't get translated to the assembly line, where Joe Blow fills tablets with pellets and Jill Blow stamps out containers.
Government can only do so much, Hussain said. Drug companies themselves have to take the initiative with regard to quality control, policing themselves to ensure good product. Part of that is education on what is required, either in college or seminars or certificate courses or what have you.
"The knowledge of many people is still very incomplete," Smith said.
E-MAIL: aedwards@desnews.com
