You’ve been diagnosed with terminal cancer. It has metastasized in your lungs, your bones, your lymph nodes; you have only weeks, months, years, and the best of modern medicine is doing little to abate your suffering. You’re exhausted. You’re dying.
Given the chance, would you take the opportunity to use an unapproved drug smuggled in from another country?
Because of the extensive, multi-tiered drug approval process implemented by the U.S. Food and Drug Administration (FDA), many people with terminal diagnoses are doing just this, a movement that serves to highlight the immediate need for the FDA to create a streamlined system to approve drugs already in use in other countries.
According to the U.S. Food and Drug Administration website, the drug approval process in the United States requires drugs to be evaluated through three phases of testing before being submitted as part of a “New Drug Application” to the FDA. The testing process can take several years, and once submitted to the FDA, the approval process aims to take approximately 10 months for standard drugs and six months for priority drugs.
This time-intensive process is in place to do everything possible to ensure that the drugs offered to Americans are truly helpful. It is designed to expose the weaknesses, limitations and drawbacks of potential drugs so that they can be used as safely as possible, but this same process that aims to protect patients has also proven itself to be cumbersome, rigid, and in desperate need of an update.
A recent New York Times article titled “A Souvenir Smuggled Home from Cuba: A Cancer Vaccine,” revealed the stories of several Americans diagnosed with cancer who, in the absence of effective, FDA-approved cancer treatments, traveled to Cuba to obtain a drug which they then smuggled back to the U.S. The drug, Cimavax, was designed to stop the growth and recurrence of non-small-cell lung cancer and has been available to patients in Cuba since 2011. The article stated that since then, dozens of Americans have traveled to Cuba for the sole purpose of purchasing the drug in hopes that it could help in a way that the drugs available in America could not.
According to the FDA website:
“In most circumstances, it is illegal for individuals to import drugs or devices into the United States for personal use because these products purchased from other countries often have not been approved by FDA for use and sale in the United States. For example, a drug approved for use in another country but not approved by FDA would be considered an unapproved drug in the United States and, therefore, illegal to import.”
To put this in more concise terms: Bringing non-FDA approved drugs into the United States, even with the sole intent of personal use, is illegal. Regardless of how long a drug has been in use in other countries, regardless of the testing regime to which it has been subjected in other countries, regardless of the potential to be lifesaving, importing drugs not approved by the FDA is illegal.
While the base tenet of this law makes sense — the FDA wants to ensure that all drugs in use in the United States are held to its specific standards — the law is rigid to the point that it actually limits the options available to terminally ill patients. While it should not be done away with completely, the law certainly needs to be revamped. Instead of generally banning imported, unapproved drugs, the FDA should implement a fast track program for drugs that have been in use successfully in other countries for a certain period of time. By making use of the research already conducted by the country in which the drug originated, the FDA can make imported drugs that have been proven to significantly improve or lengthen the lives of terminally ill patients more quickly, legally available to U.S. citizens.
Such a program would certainly need to be accompanied by several caveats. Potential users would need to be informed that the drug they are trying has been subject to a different and abbreviated testing regime than is considered the norm. The FDA would need to decide to what standard they will hold foreign drugs and what is an acceptable level of risk. That said, Americans, particularly those diagnosed with terminal illnesses, should have the option to take risky, less stringently tested drugs if they so wish, and an FDA fast track would help make this possible.
The FDA approval process is so lengthy that it prevents today’s patients from having access to potentially lifesaving drugs. Cimavax, for example, has now been introduced into the U.S. drug approval process, where it will likely spend years in clinical trials. Creating an expedited drug approval process specifically for drugs already commonly available in other countries would provide new opportunities for patients who have already exhausted their options in the United States or whose diagnoses are unaffected by current FDA-approved drugs.
Mick Phillips, a U.S. cancer patient who travels to Cuba annually to obtain vials of Cimavax, said it best in a New York Times article: “There’s no doubt that without this medicine, I would be dead.”
The FDA needs an update. Patients diagnosed with terminal illnesses need help — and hope — now, not several years down the road.