Keeping A Leash On The Pharmaceutical Sector With FDA Compliance Guidelines

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. If a low ranking score is given then a product will not be released onto the market until it has been through thorough inspection. This will allow the FDA to reduce the number of dangerous ingredients that patients in America are subjected to. 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. And FDA compliance laws must also be adhered to if a foreign manufacturer wants to export their drugs to the US. This means that the FDA is monitoring about 130,000 foreign importers every year and around 300,000 foreign facilities. 40% of all the medicines that the American people take are imported from abroad. And out of that 40%, nearly 80% of all active pharmaceutical ingredients come from foreign facilities.

This number is massive and the FDA has a hard time monitoring all of the importers. There have been cases over recent years when contaminated medicines have found their way onto the US drug market and patients have become ill and even died. One example is the 2008 case of contaminated Heparin which caused hundreds of deaths worldwide. A trial of PREDICT has been carried out in Los Angeles and the programme should be rolling out around the country by the end of Spring.