Anyone who follows pharma knows that FDA has called manufacturers on the carpet quite often over the past few years. One by one, some of the biggest names in the industry have had to ratchet back or suspend production to fix some scary-sounding manufacturing violations.
The New York Times catalogs some of the most egregious examples, pointing out that it's not just compounding pharmacies that have fallen short on the quality side. FDA-regulated drugmakers have fallen short, as aging manufacturing plants fail to live up to quality standards. "In the industry, everyone knows that all of the factories are in terrible shape," one expert told the Times. "I think people think this is an outsourcing problem, but these factories are in our own country."
It's no doubt an exaggeration to say that every factory is struggling. Indeed, a Generic Pharmaceutical Association official says that some older facilities have been well cared-for, like vintage automobiles. "That's what these facilities are," SVP David Gaugh told the Times. "They're maintained muscle cars."
With these manufacturing slowdowns and shutdowns feeding a record number of drug shortages, FDA's oversight has come under political attack. But the agency's crackdown has plenty of support, too. Especially as the media reported that rust, maggots and urine had been found in inspected plants, and human hair and weevils turned up in drug vials.
Manufacturers are spending big money to fix their plants. Teva Pharmaceutical Industries ($TEVA) has plowed $375 million into upgrades at a California plant. Hospira ($HSP) expects to spend the same amount to fix its own manufacturing problems. Ben Venue, whose shortfalls triggered a shortage of the Johnson & Johnson ($JNJ) cancer drug Doxil, spent more than $300 million to upgrade an Ohio factory that's now resuming production. And so on.
The FDA shows no sign of backing away from its manufacturing standards, though it is looking for ways to better coordinate fixes with drugmakers. So, the series of warning letters is likely to continue.
- read the NYT story