More and more state governments are pushing for their citizens to have the rights to make choices that have for years been blocked by the Federal government. In recent years, issues like the legalization of marijuana, equity crowdfunding, and more recently “right to try” laws are blurring the lines of state and Federal authority.
The Federal government, through the U.S. Food and Drug Administration (FDA), has long been the sole authority in determining what medications are considered safe and effective and deciding how drug companies, doctors, pharmacists and patients can market, prescribe, dispense, sell and purchase those drugs. But now in 16 states, state legislatures have decided that those decisions can be made by consent of terminally-ill patients and the manufacturers of experimental, unapproved drugs.
The map below shows the states where “right to try” legislation has been introduced (yellow) and signed into law (green), with links to the signed bill or current legislation.
As with many bills that have such personal impacts, the “right to try” movement comes with some very personal stories.
State Rep. Joann Ginal, the lead sponsor of CO HB1281, introduced the bill after seeing the positive impact that experimental drugs had on her older brother, who was suffering with a rare blood cancer.
Jett McSherry, a college student diagnosed with muscular dystrophy and was facing a long and expensive wait to gain access to clinical trials.
During a hearing in Missouri, legislators heard from a girl dying from a brain tumor and the father or a patient dying from metastatic colon cancer. That father was also a doctor.
But beyond the stories, advocates say there are real benefits for “right to try” laws. They say that that while FDA already has a program that often approves similar, yet little known, “compassionate use exemption” requests – but patients must fill out pages and pages of burdensome paperwork. They say that these are “promising drugs” – usually in the advanced clinical stage with substantial testing on human patients with encouraging results. They say that “right to try” keeps desperate patients from trying even more dangerous and experimental remedies from unqualified “health professionals” or available abroad in countries with less stringent regulatory processes.
But not everyone is in support of these laws. Many say there could be unintended consequences to these laws. Advocates against “right to try” laws say that these laws weaken the authority of the FDA, undermines the drug development process, and could allow drug companies to get experimental drugs into the marketplace by working with doctors to find vulnerable patients that in their desperate situation might be inclined to try potentially dangerous drugs that cost a great deal but have no verifiable benefit. Worst case they say, is that “right to try” bills could simply cause more harm than good by providing access to medications that have not been proven safe and/or effective.
However even where “right to try” laws pass, patients hoping to get these drugs face another hurdle. “Right to try”laws do nothing to compel drug companies to participate, and the drug companies must be willing to give patients the potentially life-saving medications they request. Even with the new laws, many drug companies may refuse these requests because of lack of adequate supply, cost, liability concerns, and a fear the FDA could take retribution when their drug finally gets considered for approval.
But the biggest argument against “right to try” is that many, especially the drug companies and regulators, say that new bills offer nothing more than “right to beg.” They say that many people are using legislation that “legalizes” something that is already legal simply to pressure drug manufacturers to participate.
Drug companies are often seen as the bad guy in these high profile right to try cases. While these companies might have legitimate reasons for refusing requests, those reasons are become very hard to justify they deny a chance at life for a seven year old boy – such as the case of Josh Hardy.
That has moved some advocates to call for funding and other incentives that might persuade drug companies to accept more “right to try” requests. Drug companies might favor a two track system. The drug companies say they should be allowed to follow the treatment and results (good or bad) through to the very end, but also say that given the experimental nature and terminal state of the patient, any “right to try” treatment should not count against them during the FDA approval process.
In the end, while “right to try” has been somewhat controversial, the bills do little more than stream line a process that the FDA already has and experts say is almost always granted. Then why have the law at all? I think the real value in the law is raising the awareness of an opportunity for people that searching for hope. And sometimes hope is all a terminally-ill patient or their family has to go on.
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