Tainted Pills Hit US Mainland

Tech.Luver notes an AP story on tainted pills that have arrived in the US from — not China this time — Puerto Rico. The article details a disturbing number of incidents of contamination investigated by the FDA over the last few years. "The first warning sign came when a sharp-eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors. After the flecks were spotted again on the capsules, a blood-pressure medication called Diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas. But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated — or prevent future contamination, according to US regulators... FDA officials say the problems in Puerto Rico are proportionate with the large number of pharmaceutical plants here and generally no worse than those on the US mainland."

Comments

Two observations

[Red Flayer]

FTA:

The FDA's San Juan office has 22 inspectors who devote about a quarter of their time to pharmaceutical plants. They typically visit the factories once every two years, more often if there are consumer complaints or the company has repeated infractions.
[snip]
Scharmann, a consulting editor for the watchdog publication Dickinson's FDA Review, said the FDA is concerned by anything that affects drug quality but considers the likelihood that the companies may file legal challenges to enforcement actions.

Two interesting things there -- first is that plants are only inspected every two years unless they are flagged due to poor prior performance or consumer complaints. Why not have inspections with a random interval? Yah, I know -- cost. But considering how many pills these plants pump out, you'd think there'd be stricter oversight. Or is it that we just trust pharmaceutical companies to do the right thing (which means avoid the nightmare of tainted pills splashed across the evening news)?

Other interesting point is that the FDA chooses not to fine companies/enforce regulations because of the cost of responding to legal challenges from the manufacturers. What excatly is the point of having oversight and inspections, then? Basically, the FDA must have crystal-clear evidence of plant-to-market malefeasance before they can do anything.

I guess the pharma industry has gotten their money's worth with their campaign contributions. A hamstrung FDA on a shoestring budget means strong profits for big pharma.