Envita and the FDA: Considerations for the Natural Medical Field
Let’s talk about Envita and the FDA. All you have to do is Google “Envita” and a link to our FDA warning letter pops up on the first page of search results.
According to an ex-employee of one of the major pharmaceutical companies, many companies, big and small, get warning letters from the FDA. If you go to the FDA’s website , you can search warning letters by corporation. There is even a separate database specifically for pharmaceutical corporations. Ten of the 30 biggest pharmaceutical companies have each received anywhere from 1 to 14 warning letters in the past ten years. (“Big pharma” is generally defined as any corporation that makes in excess of $3 billion a year in revenue, or who has research and development expenditures in excess of $500 million.)
So what does it mean to get a warning letter from the FDA? Is that a BAD thing? The answer is: it depends. For some, yes. Some companies and big drug corporations have received letters for such violations as drug contamination or adulteration, which is never a good thing. This problem is one of bad manufacturing. But for others, receiving a warning letter may not be so bad. Some warning letters stem more from a “problem” of innovation.
This “problem” of innovation is no more apparent than in the area of biologics. In fact, innovation literally defines the field. Biologics is a relatively new area of medicine, and the FDA has a separate biologics specialty Center, which is the group that issued Envita’s warning letter.
The FDA provides the following definition: “Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology.” For example, in our case, it was our use of the body’s own natural killer cells to treat cancer. According to the FDA’s Center for Biologics Evaluation and Research (CBER), biological products “often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or other treatment options.”
In practice, “cutting-edge” can mean a gray area when it comes to regulatory categories and restrictions.
Case in point: On June 14, 2006, we received a warning letter because the FDA viewed our natural killer cell therapy to constitute a biological product, requiring an investigational new drug application (IND). Although Envita regarded its treatment as the practice of medicine and not within FDA’s jurisdiction, we felt that the possibilities presented by the natural killer cell therapy were so promising, we decided not to give up this new approach to cancer treatment.
Envita stepped up to the plate and did the work to come into compliance with FDA requirements for production of natural killer cell therapy and to develop the protocol for initial research into this promising area of treatment for various cancers. After we submitted our investigational new drug application for the natural killer cell therapy, the FDA paid us a surprise visit to inspect our facility as part of their determination whether to approve our clinical drug trial application.
There were in fact two inspectors who showed up for this surprise visit, which turned out to be a training session as well. The FDA sent an inspector from its main office in D.C. to train the local inspector who was learning how to inspect a biologics facility! Our staff actually helped give this new inspector some insight into cellular biologics and things to look for when inspecting other facilities. The visit was a reminder of how new this developing area of medicine truly is.
For companies and practitioners who receive warning letters for the problem of innovation, what matters most is what they do after they receive a warning letter – whether they comply with the FDA’s corrective instructions or not.
We believe we are better for it. We view our warning letter as a positive because we received it for our innovation in a fledgling area of medicine. We made the necessary adjustments and have moved forward. In the process, we raised the bar for other natural medicine facilities and practitioners who would attempt to follow us into this area. Too much of natural medicine is not held to the same standards as traditional medicine, which has led to great disparities in our field. This lack of accountability has allowed “quacks” and charlatans to thrive- those individuals who give our field a bad name through the sale of harmful or ineffective “treatments.”
Many of those clinics or doctors in the field who receive FDA warning letters run away. They take their operations to Mexico or the Bahamas because they don’t want to spend the time or the money to get into compliance with U.S. standards. Or, they continue to administer treatments in secret, which only serves to put patients at risk and discredits the profession.
Running away is not the answer. It’s time to step into the light. If natural medicine is ever going to be recognized as the wonderfully powerful source of healing that it is, natural medical clinics and practitioners have to get on board the regulatory train. It’s the only way to advance the field and change the health care system for the better.
Resource Links:
Envita’s Second Response Letter
FDA’s Center for Biologics Evaluation and Research (CBER)
Envita’s Life-Saving Info for Patients: How to Distinguish “Quackery” from Advanced Natural Medicine
