FDA Compliance Gets Tougher

There have been some major developments within the US Food and Drug Administration in recent months and they signal a new era for the drug and pharmaceutical industry. The leadership within the agency has changed, with Timothy Ulatowski declaring the changes as significant in terms of FDA Compliance. All members of the agency are moving towards more stringent enforcement and harsher punishments for noncompliance in an effort to make pharmaceutical companies within the US more equal and improve the overall quality of medicines given to the US public.

Margaret Hamburg, a commissioner at the agency has voiced her concerns that the practise of some companies to ignore FDA compliance rules has a negative effect on the rest of the industry as well as patient’s health. At a recent conference she spoke about how some companies feel that they can only be competitive if the ignore compliance rules, which can be dangerous. By enforcing the FDA’s regulations more stringently, all companies will have to work to their rules, making the market much more even and less open to abuse.

There are many ways in which the FDA are tightening up their authority over rogue manufacturers. Inspections will be stepped up at the companies who have a past history of non-compliance. Any companies which are found to be in breach of the FDA’s compliance regulations will be warned and given a shorter period of time to change their production, research and clinical processes before the agency re-investigates.

Not only are these measures intended to clean up the industry, but the FDA hope that they will also increase public confidence in the agency, which has been low since the Heparin contamination in 2008 which should have been prevented through stronger FDA regulatory checks. This is essential to drive down the popular trade in illegal medicines over the internet which many people buy as a cheaper alternative to prescription drugs. Many of these black-market products have never been tested by official representatives and they can be fatal when taken incorrectly. The FDA hopes that y increasing public confidence in them, people will be happier to pay for tried and tested medicine.

With these new policies over FDA Compliance, I am sure that many companies who do not fall in line with the regulations will soon be changing their practices in order to avoid the harsh punishments that come with being black-listed by the Food and drug Administration.