One question we often receive, especially from prospective American patients,
is about how we offer treatments that are not approved by the Food and
Drug Administration (FDA), a federal agency of the United States. We want
to utilize this blog to explain the process that the FDA uses to approve
drugs and treatments, as well as why we offer treatments that are not
A quick note: just because a treatment is not approved by the FDA does
not necessarily mean that is dangerous – some of our treatments
are still in the process of being approved, meaning they were not “rejected”
or “disapproved of.” CMN stands by compassionate care and would
never administer, prescribe, or suggest anything that would compromise a patient’s
safety or health.
The Food and Drug Administration (FDA)
The FDA, or Food and Drug Administration can be traced back to 1862 when
it was composed of a “single chemist in the U.S. Department of Agriculture.” Currently, the FDA is responsible for a “staff of approximately
15,000 employees and a budget of $4.4 billion in 2014, comprising chemists,
pharmacologists, physicians, microbiologists, veterinarians, pharmacists,
lawyers, and many others.”1 The FDA has various responsibilities, which include regulating tobacco
products, assuring that most foods (excluding those looked after by the
U.S. Department of Agriculture) are labeled correctly and safe for consumption,
and, most importantly, “ensuring that human and veterinary drugs,
and vaccines and other biological products and medical devices intended
for human use are safe and effective.”
The FDA has a lengthy and detailed process that all medical companies must
follow in order to gain approval, or clearance, for public consumption.
This process is somewhat antiquated, as it has struggled to keep up with
the rapid advancements that modern technology has brought us.
The Approval Process
The approval, or clearing, process for new drugs, devices, or treatments
is extremely length and expensive. Currently, “it takes on average
12 years and over US$350 million to get a new drug from the laboratory
onto the pharmacy shelf. Once a company develops a drug, it undergoes
around three and a half years of laboratory testing, before an application
is made to the U.S. Food and Drug Administration (FDA) to begin testing
the drug in humans. Only one in 1000 of the compounds that enter laboratory
testing will ever make it to human testing.”
This is the average for the approval process; oftentimes, it takes much
longer to clear a drug or treatment for use because the FDA can come back
with conditions or criteria that must be met before the course can continue;
such conditions may take years.
“For example, the FDA might request a postmarketing, or phase 4,
study to examine the risks and benefits of the new drug in a different
population or to conduct special monitoring in a high-risk population.
Alternatively, a phase 4 study might be initiated by the sponsor to assess
such issues as the longer- term effects of drug exposure, to optimize
the dose for marketing, to evaluate the effects in pediatric patients,
or to examine the effectiveness of the drug for additional indications.”
The FDA approval process has recently come under criticism for its extensive
timeline; “there has been a push among lobbyists representing device
manufacturers to streamline the lengthy FDA approval process, arguing that the USA will lose its ability to compete globally due to
the excessive costs and delays in obtaining FDA approval.” While people may feel protected or a sense of extra security by requesting
treatments that are specifically FDA approved, it is important to recognize
that there may be updates, newer versions, or more modernized advancements
that are not yet available for use because they are still in queue or
the process of being approved. Technology is advancing rapidly –
as it has been over the past several years – and the current FDA
model is not equipped to deal with such frequent advancements, and as
such, it is difficult for treatments or medicines to be approved in a
Even if approved, the time before which patients can begin to use the newly
approved device, medicine, or treatment is still delayed even further,
due to insurance regulations. New treatments need to be studied to see
where it will fit in patients’ insurances, and whether or it not
it is even worth the liability exposures to be included on insurance plans.
Time is of the essence when one is faced with a medical predicament, especially
if it is an emergency, and the time it takes for the FDA and insurance
agencies to approve new advancements are often not sensitive to this.
Further, it is worth noting that although the FDA is a certifiable agency,
it is not flawless. For example:5
“the oversight of device innovation and the approval process has
been criticized recently due to several notable device 'failures'
that have been linked to patient harm. These devices were approved for
use through FDA humanitarian device exemption (HDE) or 510(k) processes,
which do not require randomized controlled trial evidence demonstrating
safety and effectiveness prior to approval. Unfortunately, such failures
are certainly not new. Between 2005 and 2009 nearly 700 voluntary recalls
of devices occurred per year, and the vast majority of these were class
II recalls, defined as technologies that could result in 'temporary
or medically reversible adverse health consequences'. The failure
of these processes to detect potentially harmful devices before their
release onto the US market has led to a strong backlash, by both physicians
and the public at large, against the current regulatory processes in place
through which such technologies are approved for use.”
The FDA is respectable and has helped to provide regulation standards admired
by health agencies worldwide. However, it is not the ‘end all, be
all’ of the health industry, particularly in the field of cancer
treatment due to the need to act fast to both treat cancer and to integrate
new, advanced treatments into hospitals.
How does this affect CMN and how will this affect my time at CMN?
The Food and Drug Administration, or FDA for short, is an American federal
agency; its rulings, approvals, and statements apply specifically to the
United States and its other territories. As such, the FDA does not control
what treatments are carried out or what prescriptions are prescribed at
CMN Hospital, which is located in in Northern Mexico. Nevertheless, the
treatments we offer have undergone rigorous testing and protocols to ensure that
they are safe for people to utilize as alternative cancer treatments.
CMN is an alternative cancer treatment hospital that aims to serve our
patients with the highest levels of transparency, comfort, respect, and
compassionate care. We are located in Mexico, sixteen blocks from the Mexico- United States
border, and are able to offer
treatments that have yet to be approved by the FDA that are considered to be highly
advanced, innovative, and cutting edge in the field of cancer treatment.
To get in touch with us and discuss coming to CMN, you can contact us
here or email us at
 Lispky, Martin S. MD. et. al. “From Idea to Market: The Drug Approval
 Fargen, Kyle M. et. al. “The FDA Approval Process for Medical Devices.”
 Swann, John P. Ph.D. “FDA’s Origins.”
U.S. Food and Drug Administration.
 “What does FDA do?”
U.S. Food and Drug Administration.
 “New Drug Approval Process.”