Fast-Tracking the FDA
In a previous blog post, I noted that while the FDA is currently releasing directives to put calorie information on vending machines, there is little being done to expedite the FDA’s process of approving new drugs and medical procedures. Washington ought to consider the “Free to Choose Medicine Initiative” popularized by the Heartland Institute to achieve this.
The principle feature of “Free to Choose Medicine” goes directly at the shopworn and inefficient FDA drug approval process by redefining it away from its currently impossible task: ensuring the absolute safety of all new drugs brought to market.
Currently, rather than admit that 100 percent safety can never be achieved, the FDA keeps coming up with ever more rigorous, time-consuming and costly standards of review that keep new drugs off the market even though there is a demonstrated need for them. There are literally hundreds of cases where a drug that would ultimately prove safe and effective was delayed for months or years - and tragically, patients who needed the drugs died before they could be made available.
The “Free to Choose Medicine” initiative would reform the FDA by creating a second drug and medical device approval track. On this second track, doctors and patients would play a more direct role in determining the utility of new or experimental treatments.
By creating two tracks, the status quo is maintained for anyone who still wishes to rely upon the existing approval process while providing an alternative for others that could save lives. Patients with either a terminal diagnosis or a chronic illness could have access to drugs submitted to the FDA for review and judged to be generally safe but not yet ready for formal approval.
In order for the 2nd track to work, pharmaceutical companies would have to make available all existing relevant information on the drug that is waiting for approval. Patients, in consultation with their doctors, would agree to accept that there are some risks associated with using the unapproved drug.
These patients in consultation with their doctors would keep track of their medical progress with the results submitted to a nationwide Trade-Off Evaluation Database - a database that would be open to medical practitioners nationwide. The FDA would be legally authorized to use the results as a way of either approving or denying the drug for public use. This process could reduce by 4-6 years the amount of time that drug approval takes. And lower drug approval times means lower costs for patients.
Patients will have access to more treatment options sooner and doctors will be able to better understand the results of various treatments. Moreover, since companies' research costs are lower, everyone can benefit from the reduction in drug costs.