FDA Drug Approval

To schedule a video consultation with Dr. Payan at CMN Hospital please contact us.

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 FDA approved.

The Food and Drug Administration (FDA)

 While the FDA's non-approval of a treatment doesn't automatically imply its danger, it's important to note that some of our treatments are still undergoing the approval process. This means they haven't been outright rejected or disapproved. At CMN, we prioritize compassionate care and would never compromise a patient's safety or well-being by administering, prescribing, or suggesting anything that could be detrimental.

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.”[1] 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.”1The 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.”[2]

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.” [3]

Courtesy of the Independent Institute, this infographic details the average process for FDA approval. 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.” [4] 

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,[3] arguing that the USA will lose its ability to compete globally due to the excessive costs and delays in obtaining FDA approval.”[5] 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 timely fashion.

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:

“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.”

While the FDA deserves respect for establishing regulatory standards acknowledged by health agencies globally, it is not the ultimate authority in the realm of cancer treatment. Prompt action is crucial for effective cancer treatment and integrating innovative therapies into medical facilities. How does this affect CMN, and how will this impact my treatments 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, located 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.

Contact Us 

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 info@cmnact.com. 

References

[1]Swann, John P. Ph.D. “FDA’s Origins.” U.S. Food and Drug Administration.

[2]“What does FDA do?” U.S. Food and Drug Administration.

[3]“New Drug Approval Process.” Drugs.

[4]Lispky, Martin S. MD. et. al. “From Idea to Market: The Drug Approval Process.” Medscape.2001.

[5]Fargen, Kyle M. et. al. “The FDA Approval Process for Medical Devices.” Medscape. 2013.