Lately, I have been writing about the significant disappointment and anger I feel towards the FDA. Congress has directed the FDA and the FDA’s own regulations require that they have a system for accelerated approval of drugs. Yes, they do have the regulations in place, but they have stopped abiding by their own rules. The FDA has decided to ignore congress and the American people. In truth he FDA no longer has an operating system for accelerated drug approval. The FDA has ignored their own regulations which require an accelerated drug approval process.
From 1995 to 2005 the FDA did approve 26 new drugs using the accelerated approval process, but since 2005 only one drug as been approved!
The regulators at the FDA have abandoned those of us with any life threatening disease and our families. They should be risk adverse for drugs that do not treat life-threatening diseases, but for those diseases that are guaranteed to kill us, they must allow us to decide whether we want to take a risk.
Not only has the FDA not approved the drugs we are so much in need of, but their policies have discouraged many biotech companies from the development of groundbreaking treatments.
Aimee and Scott both posted comments to my August 1st entry. Aimee asked what are we to do to change the situation. Scott replied that we need to support the advocacy groups that lead the call to approve the drugs we are desperate to use. Scott is correct. All of these advocacy groups need your financial assistance, including Malecare. Malecare is staffed entirely with unpaid volunteers. It does not take any money from drug companies; our only source of income is from private persons who wish to support us. If you would consider making a contribution go to our web sight at www.malecare.com
I would like to add to Scott’s recommendations that each one of our family members, our friends and us immediately contact our representatives in congress and demand that congress insists that the FDA is called to task. Congress must require that the FDA follow their own directives and use the accelerated approval process as is currently spelled out in the FDA’s own regulations.
You can find out how to contact your representative at the on line directory for congress
Joel T Nowak MA, MSW