The Real Horror is the FDA’s Drug Approval Process

Published November 11, 2019

The FDA has unlimited power and control when it comes to the treatments and therapies terminally ill patients can access. The process and speed in which it takes to develop drugs is also dependent upon the FDA.

Currently, it takes 12 years and $2.9 billion to bring a drug from lab to patients. The antiquated FDA drug approval process is costing Americans more than dollars and cents, but lives of families and friends.

Consider this: Nearly 30,000 Americans are affected by Amyotrophic Lateral Sclerosis (ALS). Today, there is a drug that offers hope for patients suffering from ALS. NurOwn is a drug that is on the edge of new medical technology using stem cell research to treat patients. NurOwn was given fast-track status more than a year ago by FDA, yet the small bio-pharmaceutical company Brainstorm is yet to market the drug to patients desperately awaiting its approval.

The intent of the FDA is to supposedly expedite the approval of safe drugs by fast-track designation. However, the bio-pharma companies investing in research and development to appease the strict FDA drug trials have little market incentive to deliver to patients before they have received a gold stamp of FDA approval; therefore, they don’t.

It seems if the FDA’s intent is truly to approve safe drugs sooner, then they would be supportive of a Free to Choose Medicine Track that would offer an effective pathway to expedite unapproved therapies and treatments to patients waiting on their death beds.

The cringe-worthy practices of the current FDA clinical trial process is what really ought to be brought into question. The FDA drug approval process consists of clinical trials that are inhumane in nature. In cases of rare diseases, patients fighting for their lives are often forced to fight the federal government for access to unapproved therapies by way of clinical trials.

Many patients who wish to access lifesaving drugs are denied access because said patients don’t meet the FDA’s criteria; this could be caused by merely having been diagnosed with a disease a few months earlier than the FDA requires.

What’s more shocking is that, 50 percent of patients who are chosen as glorified guinea pigs for an FDA trial are often given a double-blind placebo, meaning they are given sugar pills and used as a control for the FDA experiment, unbeknownst to them, of course.

There is an economic and human toll in not acting in support of reforms. The clinical trial process is outdated and is not keeping up with what the private sector is demanding. Even intent by the FDA to get drugs to market sooner is not adequate, as so many bio-pharma companies are left to appease the FDA, when their real focus should be appeasing patients.

[Originally Published at The Hill]