Roosevelt Institute | Cornell University

Patients Already Have A Right-to-Try—And They Deserve More

By Isabella HarnickPublished October 22, 2019

Roosevelt
The Right-to-Try Act was adopted by Congress with the intention of permitting critically ill patients the ability to circumvent the Food and Drug Administration’s (FDA) approval process in order to access to unapproved treatments. However, the FDA continues to play an important role in consumer protection and should not be so quickly overlooked.

In May 2018, the Right-to-Try Act was adopted by Congress with the intention of permitting critically ill patients the ability to circumvent the Food and Drug Administration’s (FDA) approval process in order to access unapproved treatments. President Trump has been promoting this law as an act that saves lives: As Trump signed the Bill, he said, “countless American lives will ultimately be saved. We will be saving—I don’t even want to say thousands because I think it’s going to be much more—thousands and thousands, hundreds of hundreds, we’re going to be saving tremendous numbers of lives.”

But this isn’t what has happened: A recent survey found that despite the Right-to-Try law being passed, approximately half of all drug makers would still require the FDA to review whether access is approved for the patient. Arthur Kaplan, who heads the division of medical ethics at the NYU School of Medicine said, “At the end of the day, [companies] control their products. It’s their property. You can pass a law saying people can try things, but unless you obligate companies to give you something, there’s no right to access.” With 13 out of 29 drug companies indicating that they want some sort of regulatory approval by the FDA, it’s hard to believe that this law has had any significant impact on patients’ lives.

This is also in part because the Right-to-Try Act itself was unnecessary: The FDA already is successful in getting patients with critical conditions access to experimental treatments that have not yet been approved. Within the last five years, the FDA approved 99.4 percent of the requests it receives within days. The only difference between the FDA’s policy and the Right-to-Try bill is that the FDA is removed from the equation. However, given the fact that drug companies aren’t even willing to provide the necessary approval, there really is not a difference.  Trump has proclaimed bureaucratic hurdles get in the way, but, yet again, this is not backed up by any evidence.

Another consideration is the growing area of counterfeit medicine—drugs that contain inadequate active ingredient dosages. Given that 70 percent of drugs pass phase one testing, but then do not pass subsequent phases demonstrates the continued role the FDA should play in the approval process. While physicians should be able to keep in mind the best interests of their patients, some may own pharmaceutical company stock and could charge patient treatment fees that distort their decision-making processes. The FDA continues to play an important role in consumer protection and should not be so quickly overlooked.

There are still ways to improve the current approval system for critically ill patients looking for hope: Affordability remains a constant problem not only throughout the healthcare industry, but also in regards to experimental treatments. In order to gain access to these unapproved drugs, patients must be able to pay for the drugs out of their own pockets. While a few states forbid companies from charging for Right-to-Try drugs, the majority do not. In fact, it has been found that insurance companies have denied hospice coverage, home health-care coverage, and even healthcare coverage at least six months after treatment, creating a huge financial burden left for families that already have to deal with a huge emotional burden. As a result, the real hurdle is not bureaucracy, but affordability.

The idea of providing terminally ill patients with access to unapproved treatments is undoubtedly intriguing, which is why it has been an established pathway for many years now through the FDA. The goal should not be a “Right-to-Try,” but a right to safe, effective, and affordable drugs. Simply put, there are too many problems in the healthcare industry to enact repetitive laws addressing problems that have already been resolved. While the FDA can take care of ensuring safety and effectiveness, it’s up to policy to ensure headway is made on providing access to more affordable drugs to treat critically ill and everyday patients, alike.