The Food and Drugs Administration (FDA) doesn’t yet have the necessary resources and clout to monitor the safety of new medications and respond effectively when something goes wrong, said a panel of experts from The Institute of Medicine in a new report, called The Future of Drug Safety. The FDA needs more resources – money, staff and powers – to effectively monitor and ensure the safety of medications.
The report said there is a perception of crisis that has undermined the credibility of the FDA and of the pharmaceutical industry – the FDA, the pharmaceutical industry, Congress, professional societies and health care agencies all agree that parts of the system need to be improved.
The report said that the FDA and the pharmaceutical industry need to be more transparent and accountable to the public by communicating all safety concerns in a timely and effective fashion.
The report said restrictions on labeling and advertising of new drugs should be tightened up – more emphasis should be placed on what is not known about the newly-approved drugs’ safety.
Two years after Vioxx was taken off the market, the report indicates that the situation is far from ideal. As soon as lots of people start using a newly-approved drug, the FDA lacks the resources to monitor its safety.
According to the report, drugs are being approved more quickly – there is less time to properly check the pre-marketing safety data. It painted a lopsided agency, with more resources being used for pre-approval functions than post-approval functions.
Although the report recognized some recent steps to improve drug safety, it stressed that major obstacles still remain.
The report recommends, among other things, that:
— The FDA receive more money
— All newly-approved drugs be reviewed after five years
— All newly-approved drugs carry a symbol for two years
— Advertising of all newly-approved drugs be restricted
The Future of Drug Safety. Action Steps for Congress
Click here to download the report
Written by: Christian Nordqvist
Editor: Medical News Today