How to Speed Up the Drug Approval Process

To participate in the second tier, pharmaceutical companies would have to make available all existing relevant information on the drug. Patients, in consultation with their doctors, would agree to accept that there are some risks associated with using tier 2 drugs.

Doctors would keep track of the patient’s medical progress with the results submitted to a nationwide Tradeoff Evaluation Database (TED) -- a database that would be open to medical practitioners nationwide.

As the treatment results from the tier 2 drugs develop, the FDA would be legally authorized to use the results to issue a preliminary approval or denial. This process could reduce by 4-6 years the amount of time that drug approval takes. Once a sufficient number of patients have successfully used the tier 2 drug after it has received preliminary approval, the FDA would be required to issue final approval for the drug.

This process would benefit both terminally and chronically ill patients in the short run and all patients in the end.

Companies would benefit as well. Today investors and drug developers have to assume that their ROI -- return on investment -- will be delayed by as much as a decade before going forward with a particular field. Since there is no guarantee that research will ultimately result in a new drug, delay only adds to the risk factor of investors and leads to higher pricing once drugs are finally approved. FTCM rewards drug makers whose drugs are effective by giving them the earliest possible approval times.

Instead of the FDA taking on responsibilities like protecting the environment -- which are far afield from its original purpose -- FTCM puts patients and doctors back in the driver’s seat when it comes to their medical needs and re-orients the FDA to its real mission. 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.

Notably, these results are not just theoretical. FTCM gives patients more access and hope than the current program that pushes a lucky few into the clinical trials where they still have a 50 percent chance of receiving a placebo instead of the real drug.

Ultimately, America can’t afford to have a health care system where it is acceptable to let people suffer or die needlessly due to delay in receipt of drugs.

FTCM would empower patients by giving them the ability to decide their future. Instead of expanding FDA duties away from drug approval, Congress should explore ways to restore drug approval as the FDA’s primary mission.