Tag Archives: FDA

FDA wants to Stop Stem Cell Therapy AND Breast Reconstruction -Make Comments by Sept. 27th 2016

fdahearingUPDATE: Congratulations everyone! We submitted 6,952 comments! Click HERE to read the comments.

Sept. 24th, 2016 – Cellular therapy is a disruptive medical innovation which is revealing a surprising truth: our own bodies are the best source of medicine ever discovered. This is challenging many of the conventional therapies, such as drugs and surgery. The FDA’s regulatory approach starting in 1993 has been inhibitory to the wider adoption of this therapy. The current proposals, which seek to classify certain stem cell procedures as a prescription drug, which will only insure that more patients are forced to pursue medical tourism.

If you you think you or a loved one might ever need to use their own stem cells, for example to avoid a knee replacement, then please take a few moments to make comments to the FDA by Sept. 27th. Instructions provided below.

The FDA has presented 4 draft guidances, with the goal of shutting down stem cell clinics in the U.S. Readers of the PFSC blog helped start the citizen feedback process earlier this year when over 600 registrations for the FDA Part 15 hearing overwhelmed the agency. The hearing had to be postponed until Sept 12-13th 2016 and expanded to 2 days, which only allowed 5 minutes each for the 100 people who registered to speak. These presentations from scientists, cellular therapy providers and patients were mostly in opposition to the guidances. The legal and scientific details are available below in links to the testimony and articles.

FDA PROPOSED BAN ON BREAST RECONSTRUCTION TECHNIQUE
The FDA was roundly criticized for proposing that not only your stem cells, but also your fat, should be classified as a drug, requiring a decade of trials. Rick Jaffe, a lawyer with 3 decades of healthcare legal experience, raises the alarm in this passionate piece.

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures – Richard Jaffe, Esq. The huffington Post, 09/18/2016

HOW TO MAKE COMMENTS TO THE FDA BY SEPTEMBER 27, 2016

Click HERE to submit your comments o FDA.

Tell your own story if you have had stem cell therapy, or think you want it in the future.
In your own words (or FDA will reject it) make the following points, if you support continued access to your cells:

1. Withdraw the four HCT/P guidance documents, and work with the experts on solutions
2. Stop trying to regulate a person’s use of their own body parts
3. Continue access to responsible stem cell therapy that uses the patients’ own tissue

A great deal of media attention has arisen, so you may want to save your comment, and also post it as a comment on the articles we’ve included below.

Click HERE to read comments submitted by others.

UPDATE: An amazing 6,952 comments were submitted by the deadline of Sept. 27th. FDA has never received more than 20 comments on previous guidances.

Click HERE to review the speaker agenda for the two day hearing.
Click HERE to view Day 1 of the hearing.

1:48:00 Mary Ann Chirba (Boston College)
1:53:00 and 2:58:40 Arnold Caplan (Case Western Reserve)
1:59:10 and 2:53:00 Keith March (Indiana University)

These three presenters are leaders in the field. Caplan was the first to discover the healing abilities of adult stem cells. In FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy Richard Jaffe comments “…these presenters and especially March and Caplan showed that the FDA’s view was biologically unsound.”

Alexey Bersenev (Yale University) posted an objective scientific review of the hearing, also noting the import of March and Caplan’s input,
Historic FDA public hearing on regulation of cell therapy in US

Click HERE to view Day 2 of the hearing.
Click HERE for a patient presentation provided by SammyJo Wilkinson.

In the last presentation at the hearing, SammyJo explains how her own stem cells put long-term multiple sclerosis into remission and recovery since 2014. She also echoed the proposals for solutions presented, such as the conditional approval plan and patient registry proposed by Arnold Caplan, Janet Marchbroda (BPC) Day 1 4:16:00, and Leslie Miller (AACT) Day 1 3:23:58.

Editorial – Improving the regulatory framework for cell therapy does not equate to deregulation
Caplan A. I., Ricordi C., CellR4 2016; 4 (4): e2109

Many moving presentations were made by patients on Day 2, about lives restored by cellular therapy from illnesses that had no effective treatment options. In our next post we will explore how the media has covered the FDA regulatory story, and how the patient experience is finally being included.

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The History of FDA Control of Your Body

May 18th, 2013


(Click image to watch video)
sm1For the first time in history the FDA has encroached into the practice of medicine. The FDA made autologous adult stem cell therapy subject to the same regulatory oversight as mass-produced pharmaceutical agents. Without compliance to the Administrative Procedures Act requiring an “extensive public comment period.“ The FDA managed to expand it’s authority, without input from patients and their doctors…

sm2In the early 1990’s, the cells in your body were like any other body part that could be used by a physician and moved from one area to the next. They were body parts like a kidney or a heart. That was before an unprecedented power grab by the FDA.

sm3In the late 1990s, the FDA proposed that the cells in your body should be made drugs. They were met with stiff resistance. They ultimately decided, that if the cells were at all made more potent by growing them to bigger numbers, they would be drugs, even though they were still your cells. This was known as the “minimal manipulation” rule later codified in 21 CFR 1271.1-3. In the 1990’s this only applied to someone else’s cells that were manufactured like drugs, so this made some sense.

sm4The FDA, without the proper notice and comment making period required by the Administrative Procedures Act, made a one word midnight change in the 2006 federal register. It changed a single word from “another” to “a”. By doing this, it’s regulatory authority was expanded from simple control over someone’s cells used as a transplant from “another” person to all cells from “a” person. With this one work change, FDA granted itself sweeping new authority over your body.

sm5Up until 2008, it was assumed that FDA only meant to apply it’s rules to pharma companies who were processing cells. Then in 2008, FDA went after a physician’s office that was using the patients own cells and treated the small doctor’s office like a large Pharma company. This necessitated a suit by the doctor’s office against FDA, but this chain of events now extended FDA’s authority even further, as now your local family doctor was suddenly under the same cell based regulations as Pfizer.

sm6In 2010 and 2011, the FDA decided to place fat tissue processed at the patient’s bedside to release stem cells into the same category as prescription drugs. They made this intention clear through letters to several parties that asked the Tissue Reference Group whether this simple processing of fat was something FDA intended to control. In addition, it submitted Warning Letters to Intellicell and a Dr. Young, codifying it’s intent to turn fat tissue into a drug.

sm7So as you can see, FDA has gone from no control over your body’s stem cells as drugs in the 1990’s, to classifying an ever increasing number of you body tissues as drugs. This is despite massive opposition from these industry groups.

♦ American Red Cross
♦ Society for Assisted Reproductive Technology
♦ Osiris Therapeuticsc Inc.
♦ Northwestern University
♦ Hyman, Phelps & McNamara
♦ Biotechnology Industry Organization
♦ American Society of Clinical Oncology

What is the impact of classifying simple medical procedures as prescription drugs? The FDA has taken procedures that should by now be routinely performed as the practice of medicine, and instead placed them into a glacially slow drug approval process. Countless sick patients have been denied access to their own stem cells that may well cure or mitigate their disease.

sm8Share this page with your friends. Ask your local university if they have a focus on adult stem cell research, specifically autologous mesenchymal stem cells, expanded to a therapeutic dose. Educate your state and congressional representatives. Citizens need to take charge of the way their body parts are being regulated.

 

Further Reading:

FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!” Alliance For Natural Health, January 31, 2012

Why Can’t We Use Our Own Stem Cells to Heal Our Bodies? by Berkley Bedell, former Congressman and founder of The Foundation for Alternative and Integrative Medicine (FAIM)

FDA Stem Cell Regulation and the English Language: switched at birth? Mary Ann Chirba, J.D., D.Sc., M.P.H. August 11, 2011

FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine? Mary Ann Chirba, J.D., D.Sc., M.P.H.

Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor’s new clothes The Journal of Translational Medicine 2012 10:60