medicine-23_25

Responding to contemptuous condemnation, the Food and Drug Administration offered a blueprint to refurbish the way it monitors prescription-drug safety. This is evidently an apparent effort to deal with mounting criticism of its operations, the U.S. Food and Drug Administration released a set of initiatives, which directed to strengthen the country’s health safety net.

In recent times criticism over the agency’s regulation of the drug industry has increased significantly and especially after Merck & Co. withdrew its Vioxx painkiller in 2004. The painkiller was linked to risks of heart attack and stroke. Measures the FDA offered came in response to a September report by the Institute of Medicine. The institute had urged for immediate changes in monitoring the safety of prescription drugs once they are pumped into the market.

On the occasion of unveiling new guidelines the FDA has said that it is adopting or has adopted more than 30 safety measures to ensure a proper monitoring. However, many measures have already been announced and it will not require additional funding. Further, the FDA has suggested to lawmakers this month that they increase fees paid by drug makers for speedy reviews of new treatments as a way to pay for other safety measures.

These recommendations have included a pilot project to appraise the safety of drugs after they have been put on the market, and initiatives to make better communication both within and without the stressed agency.

In the meanwhile, a faction of experts has criticized the recommendations saying, the report includes some minor improvements, for example sharing of safety data with other agencies, however it falls noticeably short of the changes required to repair the nation’s drug safety system.

Read