Medical Manufacturers Losing Millions Due to FDA's Latest Crackdown? ?

Saint Petersburg, FL - March 22, 2011)? 

On Wednesday, March 2 2011, the Food and Drug Administration (FDA) announced it is removing approximately 500 unapproved cold and allergy medications from the market as a part of an ongoing crackdown on prescription drug manufactures.

Although the FDA requires all new prescription drugs be reviewed and approved prior to launch, thousands of drugs were already on the market before current expectations were in effect. As a result, the FDA has ordered a halt on production and distribution on all products that have not been approved in accordance with current requirements. This culling from the market will cost manufacturers of these products millions.? 

According to Advanced Biomedical Consulting (ABC), a firm that assists drug manufacturers and marketers with FDA compliance and drug manufacturing process improvements, the FDA's second phase of compliance scrutiny could end up costing companies who aren't prepared even more money. ? 

Jonathan Lewis, a principal at ABC, says that, "just being aware of potential issues before the FDA walks in the door can significantly save drug manufacturers millions of dollars and countless hours of work by having responses ready to issues before they are brought up by the investigator."??

ABC recommends pharmaceutical manufacturers do at least the following 4 activities to ensure preparation for the coming scrutiny:? ?

1. Review/Ensure that ALL Products are In Fact Currently Approved AND Electronically Registered with the FDA. ?

2. Review/Ensure that the labeling for ALL of Your Products are in Compliance with Current Labeling Requirements. ? ?

3. Review/Ensure that the Claims on ALL Labeling/Advertising (Including Web Advertising) are in Compliance with the Approved Indications for those Drug Products. ? 

4. Perform a Top to Bottom Manufacturing Site FDA Compliance Assessment (Either Your Own Manufacturing Site or Your Contract Manufacturer's Site). ? 

Saint Petersburg, FL - March 22, 2011)