Colorado Patients Win the “Right to Try” New Medicines Before the FDA Approves Them
Earlier this month, Colorado governor John Hickenlooper signed the nation’s first “right to try” law. The law allows a patient suffering from a disease, for which no medicine has been approved by the FDA, to try an experimental new medicine before the FDA approves it. The law allows, but does not force, drug-makers to provide their experimental drugs to patients. Other states, such as Louisiana and Missouri, are set to follow.
These patients are in dire straits. They suffer from diseases for which there is no other cure, and have short life expectancies. Most of us cannot imagine being in their position: They are willing to take far greater risks than most would accept, in their search for a cure.
Although the Food and Drug Administration (FDA) has an exemption for “compassionate use”, that exemption requires jumping through too many bureaucratic hoops to be useful. So, scholars at the Goldwater Institute developed the idea of state “right to try” laws that would enable residents to use experimental new drugs without FDA approval.
My first reaction when learning about the Goldwater Institute’s successes in moving this legislation through state legislatures was that the FDA would surely assert pre-emption based on the Constitution’s Supremacy Clause. The Goldwater Institute is the home of impressive legal thinking and activism, so they have surely developed a legal strategy, if they need one.
However: Maybe the federal government will not react? After all, Colorado not only allows medicinal use of marijuana, but purchase and possession of small amounts of marijuana for so-called “recreational” use. The Obama Justice Department does not litigate against state laws liberalizing marijuana use.
It would reflect a very perverse sense of justice for the U.S. government to act against a state law allowing desperately ill patients to try promising, experimental new medicines, while allowing Colorado’s marijuana market to thrive unmolested.
In the age of Big Data, much could be gleaned from allowing patients to take new medications prior to Stage III clinical trials. Depending on the toxicity profile, some stage III clinical trials could essentially be replaced with similar — but ongoing experimental trials. The clinical trial is the gold standard for approving medications. However, these trials are also extremely costly. Many new medications never make it to market because the hurdle these trials create. An alternative means that grants patients access to experimental drugs while tracking the results could speed the way drugs enter the market. Clinical trials essentially allow firms to experiment on willing patients. It time to streamline the process.
Allowing patients to willingly accept the potential risks and benefits of a product offered by a willing supplier? Stop the presses!
That’s exactly what economic freedom is all about – consumers and sellers agreeing to exchange goods and services without having to satisfy a third party (the government in this case).
One of the biggest problems with a big-government society is that bureaucrats think they have the right to intervene in people’s most intimate life circumstances. Of course Americans ought to have the “right” to willingly access new drugs even though they haven’t gone the years of slow government red tape through the FDA.
Over regulation and costs are what makes medical tourism so attractive. Perhaps some of these patients who are not fortunate enough to live in Colorado should consider it.
I simply think that this “right to try” law in Colorado is fantastic! It is especially great for those who are on their death bed waiting for the miracle cure. Like the post states, there are too many bureaucratic hoops to jump through before a drug can even be used on the “compassionate use” basis. This is great! Go Colorado!
Colorado continues to show how far ahead of the curve the are in their policies for their people. They are a very progressive state, and a good example of success for state governments to pass laws that differ from federal law and remain unchanged.
They very much stick it to the federal government with their marijuana laws and now this one as well. They show the success of less regulation and free market principles.
Plus, it should be relatively straightforward to assess the effects of the policy as a natural experiment. I wonder if there will be a lot of interstate travel by patients in other states, to take advantage of this opportunity.
This is an interesting policy in that it gives the patient more freedom in choosing their course of treatment. Especially for those whose “backs are up against the wall” because of their disease.
“Gov. John Hickenlooper stated he doesn’t want patients to die knowing there may have been a drug in existence to help them that they were not allowed to take.”
It is a shame that not all policymakers feel this way about the terminally ill and a right to choose their treatment.
But the government knows the best treatment for patients. It’s only drugs that are FDA safe and pass through the perverse bureaucracy.
“The law allows, but does not force, drug-makers to provide their experimental drugs to patients.”
I wonder what the cost on experimental drugs could possibly be. Perhaps they pass this and they are much too costly for patients use.