For years the FDA has been trying to level the playing field in terms of foreign versus domestic drug manufacturing plant inspections. It wasn't many years ago when U.S. facilities could expect a visit every 30 months while foreign plants would go 5 or more years between inspections. One way to achieve parity is to cut the number of U.S. inspections while doing more overseas, and that is what the FDA proposes to do.
As PharmaManufacturing.com points out, that is in line with what the FDA has been working toward in recent years. With a refined risk-based approach, it intends to go where the need is greatest. And with foreign producers now responsible for about 80% of the drugs and ingredients used in the U.S., foreign plants are where the inspection action is of most concern.
According to an FDA memo justifying its proposed budget, the agency expects to conduct 843 foreign plant inspections this year and repeat that the next. That would be 239 more than the 604 it did last year. In the U.S., it says it expects to do 591 inspections during each of the next two years, close to a 40% drop from the 967 U.S. inspections conducted last year. "The FY 2014 planned mix of domestic versus foreign GMP inspections shifts quite a few more inspections into the foreign arena, with a corresponding decrease to domestic GMP inspections in comparison to the FY 2013 actual, but the overall coverage is not changing," the memo explains. "This is being done to achieve greater parity of the foreign versus domestic inspections and thus level out the inspection coverage."
Part of this reflects the increase in the number of inspectors the agency expects to have in both China and India, two low-cost countries that now produce a huge amount of ingredients and finished drugs imported into the U.S. The FDA has said it is hiring 10 inspectors to be based in China and is increasing the number of inspectors in India to 19 from a dozen now, with 10 of those dedicated to drugs and the others to food.
Both of those countries have already seen more actions by the FDA with the agency banning imports from two Ranbaxy plants and two Wockhardt plants since May 2013. It also had banned some Chinese plants, and both countries have seen an upswing in facilities receiving warning letters.
The FDA is also working with regulators in Europe on ways to share regulatory oversight of sites in other countries. Its priorities for this year include expanding inspections in China and India but also to "advance multi-partner efforts to build global regulatory capacity."
- here's the FDA memo (PDF)
- read the PharmaManufacturing.com story
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