Fierce's 2011 warning letters report


The trend in pharma GMP warning letters for 2011 is that there are more of them, with a higher proportion of warnings to foreign plants, as the letters in this report illustrate.

"The FDA has more people in the field doing more inspections, and more inspections are likely to result in the issuance of more warning letters," says Meredith Manning, a co-director for the pharmaceutical and biotechnology practice group at law concern Hogan Lovells, in a phone interview. "At some point we'll reach a plateau, but I'm not sure we've reached it yet."

And if the tone of warning letters has a hard-line edge, that may be because of the agency's elimination of mandatory legal reviews. The review was required prior to the Obama administration. The ability of districts to issue letters directly means that the inspectors, who have had long-standing relationships with particular companies, have more influence over the tone and language of the letter, Manning says. Their frustration at repeat offenders shows through in more references, often terse, to repeat offenses.

Under Commissioner Margaret Hamburg, the FDA has imposed deadlines for warning letter responses and now prioritizes post-warning-letter/post-recall follow-up plant inspections. New programs will "sharpen the effectiveness and timeliness of regulatory, compliance and enforcement systems," Hamburg said in April.

The following are our picks for the top warning letters from the last 12 months. Read the report >>