The American public is not satisfied that the major healthcare legislation that became law last year really does anything to improve the system. A majority of Americans surveyed in three recent polls — CNN, Fox News and Rasmussen – all said the new law makes things worse and want it repealed.
Quite simply, Americans don’t want a big government – one-size fits all bureaucracy dictating the terms of health care services. Instead of reforming the system, the American public believes the new measure compounds an already broken process–a compounding that will inevitably lead to rationing.
Instead of centralizing control, Washington should consider innovations that give authority and responsibility back to patients and their doctors.
One truly interesting solution is the Heartland Institute’s Free to Choose Medicine initiative. If combined with other market-based reforms, it would significantly improve our health care system and give Americans more control over their health care, and provide lower costs all the while getting government out of the way.
How does Free to Choose Medicine work? FTCM makes an end run around the costly and time-consuming FDA reform approval process – a process that in some instances is approaching 10 years. At present, the FDA has as its goal an impossible task – ensuring the absolute safety of all new drugs brought to market. Rather than admit that 100% safety can never be accomplished the FDA has come up with an ever more rigorous and time-consuming review process.
While providing modest safety protection, the longer approval times give little comfort to a patient with a terminal condition. In fact, there are literally hundreds of cases where a drug that would ultimately prove safe and effective was denied to patients – and tragically, the patients died before getting access to the drugs.
Patients should have a right to make informed decisions along with their physician about whether they have access to promising new drugs. Free to Choose Medicine is a solution that could be quickly implemented. It relies on a two-tiered system: One is keeping the status quo for any who still believe it is useful or effective and the other an innovative waiver approval process whereby patients with either a terminal diagnosis or a chronic illness are allowed to access drugs that have been submitted to the FDA for review prior to their formal approval by the FDA.
To participate, 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 (TED) – a database that would be open to medical practitioners nationwide.
As the results of the database develop, 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.
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 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.
Unlike the big government health care takeover that Congress passed last year, FTCM puts patients and doctors back in the driver’s seat when it comes to their medical needs. Patients will have access to more treatment options sooner and doctors will be able understand better understand the results of various treatments. Moreover, since companies’ research costs are lower, everyone can benefit from the reduction in drug costs.
Moreover, 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 while it pursues an unrealistic quest to provide 100% perfection in the drug approval process.
FTCM would empower patients by giving them the ability to decide their future. As Congress continues to explore ways to improve our health care system, they should include Free to Choose Medicine among their options.
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