Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections.
Who led the pack?
Pacira Pharmaceuticals, which makes painkillers sold in hospitals, was the worst offender among publicly traded drugmakers with an 82 percent failure rate during 11 inspections.* Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast Mylan passed 79 percent of 56 inspections, Bloomberg writes. * [UPDATE: A Pacira spokesman called us Wednesday night to say the Bloomberg tally referred to above included FDA inspections that were made when the plant was owned by another company.]
The news service reviewed almost 10,000 inspections at US plants between 2000 and September 30, 2010, although there were no details on the nature or number of violations during each inspection. The FDA makes 0.9 visits, on average, to each facility each year, compared with 0.6 visits annually when George W. Bush was in the White House. Looked at another way, the agency NOW visits each of the 2,567 plants registered in the US almost once a year, Bloomberg reports. [UPDATE: We belatedly added the word 'now.']
To pay for inspections, the White House proposes a fee that would generate about $16 million from 329 anticipated reinspections, an FDA spokesman tells Bloomberg, which calculates violations would cost an average of slightly more than $48,600. There are no fines now, by the way. As Bloomberg notes, Republicans are threatening to slash FDA funding as they focus more on overseas suppliers as part of an emphasis on supply chain concerns.
But not everyone is impressed. Mike Burgess, a Texas Republican and vice chairman of the House Energy and Commerce Committee's subcommittee on health, believes the FDA may be overwhelming drugmakers with paperwork but not addressing safety issues. "We do need to see that things are being done wisely and that manufacturers are not being asked to comply with things that are not overall going to advance the cost of patient safety or drug safety," he tells Bloomberg.
graphic courtesy of bloomberg