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Keeping Tabs On The Pharmaceutical Marketplace With FDA Compliance Regulations

6th October, 2010 - Posted by health news - No Comments

In an effort to reduce the number of dangerous medicines which enter America the Food and Drug Administration is developing its border control policy. Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT is a way to control the drugs which enter at the border. At the border the barcodes on the medicines will be scanned and this will be linked to a central database. If the manufacturer does not have the correct licenses to sell their products in the US then the central database will be able to alert the border deputies of this fact. The medicines will not be allowed into the US if FDA compliance has not been reached.

The products that go through the scanner will also be ranked. Those medicines which receive a low ranking will be subject to more intensive investigation before they are released onto the market. The FDA hopes that this will reduce the number of substandard medicines which patients might take. Risk is measured on a number of factors including the reputation of the manufacturer, the type of medicines and other market variables.

At the moment, FDA compliance is a legality for medicine manufacturers in the US. For foreign manufacturers they too must meet FDA compliance laws before they can export their products to the US. There are approximately 130,000 foreign importers and 300,000 foreign facilities which the FDA has to monitor every year. Out of all the medicines that American people take, about 40% are from foreign producers. And 80% of all the active pharmaceutical ingredients in these drugs come from foreign facilities.

This is a massive number of importers and products that the FDA has to monitor. In the past there have been instances where contaminated medicines have got onto the market and subsequently caused health problems and even death. One example is the 2008 case of contaminated Heparin which caused hundreds of deaths worldwide. PREDICT has been tested in Los Angeles and by the end of the Spring it is hoped that it will be in place around the country.