Americans may not know that about 80 percent of the active ingredients in many of their medications are produced at 3,700 foreign plants in China, India, and other countries. With less oversight overseas, pharmaceutical companies and device manufacturers can make more product faster and cheaper. China and India do not have the standards of the U.S. Food and Drug Administration (FDA) and it has cost in a lack of American confidence every time there is a drug recall over a contaminated imported drug, such as the contamination of the blood thinner heparin that was linked to 81 deaths. In the heparin case, the Chinese government refused to open the plant to FDA inspectors.
The New York Times reports that a landmark agreement, expected to receive Congressional approval, should offer a solution. A number of generic drug companies will provide $299 million every year to fund U.S. inspections of foreign plants. The move is long overdue. The FDA can barely keep pace with domestic plants and the Times reports that about 64 percent of foreign drug manufacturing plants have never been inspected by U.S. regulators.
Expect generic drug approval to be fast-tracked as the FDA gains new reviewers courtesy of U.S. drug makers. This boost only affects generic drugs and will do nothing to tighten safety over brand name medications, over-the counter drugs, or vitamins.
The pharmaceutical litigation lawyers in Jacksonville at the Farah & Farah law firm believe this is a move in the right direction to clear up the confusion and potential for danger coming from products and plants that are not properly inspected. This might be a private-public partnership that actually is a win-win for everyone, especially patient safety.
Sources: http://www.fairwarning.org/2011/08/deal-reached-to-boost-inspections-of-foreign-drug-manufacturing-plants/ and http://www.nytimes.com/2011/08/13/science/13drug.html?_r=2&pagewanted=1&ref=health