FDA Should Tread Carefully with Stem Cell Regulation – Pain News Network

Thus, when the Commissioner asserts that the FDA will "aid in the effort to bring novel therapies to patients as quickly, and as safely, as possible," it simply belies history. Likewise, overtures made toward any potential regulations being congruent with the 21st Century Cures Act are dubious. The spirit of the Cures Act is clear; it calls for the "accelerated approval for advanced regenerative therapies."

More federal regulation rarely, if ever, leads to acceleration of anything. In fact, it almost always tends to slow things down. Thus, unnecessary and unreasonably burdensome regulation by the FDA could contravene the will of Congress, and thus the will of the American people.

Texas Legalizes 'Personal' Stem Cell Therapy

Furthermore, the FDA's prospective regulatory guidance must be viewed in the context of recent events in Texas. On June 13, Texas governor Greg Abbot signed HB 810 into law, which made Texas the first state to legitimize the use of personal stem cell therapies statutorily. The signing of the bill was celebrated not only by stem cell advocates, but by the countless Americans who suffer from chronic, debilitating conditions for which the current medical services delivery model can offer only surgery and medication. For many, it was a monumental step forward toward fulfilling the promise of regenerative medicine and realization of true health care.

However, the FDA may have seen this move as reinforcing a "wild west" stem cell landscape, a landscape which it believes it must police.

All of us, including FDA officials, should be reminded that on February 28, at President Trump's first State of the Union speech (and on Rare Disease Day), the President took note of Sarah Hughes, a young attendee who had used her own stem cells to successfully treat Pompes Disease.The therapy normalized her immune system, alleviated her symptoms and helped reduce her medications from 22 to 8.

We must also remember the promise President Trump made to America's military veterans, many of whom suffer from painful, debilitating conditions that may be treated or cured by stem cells. President Trump cares deeply about veterans' health. He recently signed the Veterans Appeals Improvement and Modernization Act, which streamlines the process of veterans appealing claims over disability benefits. He also signed a bill that will let more veterans bypass the Department of Veterans Affairs and instead receive treatment from private doctors.

Finally, he signed legislation approving new tools to expand the VA's existing Telehealth Services, so veterans can schedule appointments and have video consultations from their mobile phones. It seems obvious that President Trump would never support restricting veterans' access to the medical care they need, including stem cells.

I believe that President Trump, through his devotion to our veterans, the Congress through the Cures Act, and the American people through their need for medical alternatives, would strongly disagree with any unreasonable curtailment of stem cell therapies.

The FDA must not defer to the opinion of "industry," and must prioritize the needs of Americans like Sarah Hughes and our suffering wounded warriors. People are in pain and pills cant always help them.

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FDA Should Tread Carefully with Stem Cell Regulation - Pain News Network

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