FDA To Increase Oversight In Outsourced Drug Manufacturing
August 5, 2011
New reports say that the U.S. Food and Drug Administration is planning to spike its use of third party inspectors after complaints of a lack of oversight in food and drugs being manufactured overseas.
Regulators say that they plan to outsource more frequent inspections at factories abroad that engage in food and drug making. This is expected to be an ongoing process for about ten years and stems from staunch criticism from the Congress over the quality of oversight in the food and drug outsourcing.
The FDA’s acting principal deputy commissioner, John Taylor, said that the agency has initiated discussions with industry trade groups.
He added that the FDA will collaborate with foreign countries in order to reevaluate findings and seek for a plan that includes fewer inspections of manufacturing facilities.
Drug manufacturing plants abroad are checked once in every nine years – at an average. This figure compares to a single check in 30 months for plants based in the U.S. These statistics are based on a report submitted in September by the Government Accountability Office.
Although the FDA has U.S. staff in places like China for more than two years, Taylor commented that this kind of oversight is insufficient. There is likely to be more and more drug manufacturing that is going to take place in overseas, driven by lower costs and cheaper resources. Essentially, the health and pharmaceutical outsourcing industry reflects the need for outsourcing by big businesses across the board. With demand for newer drugs at a high, there is also a need to increase profits on the part of pharmaceuticals.
Taylor was quoted as saying as saying, “We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves.”
He was speaking at a Washington conference hosted by advisory groups, Venn Strategies LLC and Greenleaf Health LLC. He continued to say, “We’re looking at anything, anything and everything that will allow us to leverage our resources better,” reports Bloomberg News.