The new regenerative medicine unveiled by FDA has evoked mixed reactions. There are
some parts of the new guidelines which many specialists in the field such as
Cameron Clokie agree will improve the safety of patients and the overall
quality of the regenerative medicine field. Form his experience working as a
maxillofacial surgeon and biological scientist for over three decades, the
biologist and entrepreneur Cameron Clokie has several points to note out of the
new regulations. For example, the 36 months period over which FDA will take
before it can start enforcing the regulation fully will mean business as usual
to unscrupulous operators. Those businesses which are known to exploit clients
by offering substandard regenerative surgery will continue exposing patients to
danger. In general, the surgeon agrees there are many ways the regulations will
make the business better. Cameron Clokie continues to explain the different
areas where the regulations impact as outlined below:
What are the new FDA regulations?
The guidelines provided by FDA touches on two areas. There is a guideline which
touches on expediting approvals for the regenerative medicines for those
suffering from serious health complications which need urgent care.
The other guideline offers clarity on when cell tissue-based products would be exempted
from regulations. There are cases where tissue products should not be exposed to the regulations for the well-being of the patients. The FDA has provided a
clear guideline on when such incidences can occur as a way of saving patients’ lives. There is also a clear guideline on how the FDA will interpret regulatory decisions under the terms minimal manipulation and homologous use.
The field of regenerative medicine is growing. Experts in the field such as Cameron Clokie have seen the industry grow over the recent past and they agree the industry is destined to go far. But, the law requires FDA to regulate medical products which consumers can access. The ever-growing number of businesses which deal in
regenerative medicine on a direct client basis makes the industry prone to abuse. There are even clinics which have been discovered to offer substandard services, the regulations aim at protecting patients against such clinics.
What do they mean for medicine?
According to Cameron Clokie, the new regulations will change the way regenerative medicine
is practiced for good. For example, patients will access quality services
because the clinics will be regulated and vetted to ensure they offer quality
and licensed products.
There will be a reduction in delays when it comes to service delivery. Some regenerative
medicine procedures which can be used to correct different health complications
will be approved fast under the new guidelines. For example, correction of
maxillofacial deformities among other parts of the body can be done very fast.
The agency aims at speeding up the process of approving regenerative procedures
which meet the minimum set safety standards. The process of speeding up the
approval process will lead to saving more lives because processes will be
The regulations will lead to more effective procedures. For instance, FDA aims at
enforcing regulatory actions on different products which pose higher risks.
Products which will be administered by infusion, injection, intraocular and
aerosol inhalation will be passed through high scrutiny to ensure they don’t
cause adverse side effects to users. It is an approach which will lead to safe
practices in the regenerative medicine industry.
How will they change how regenerative medicine is practiced?
The new FDA regulations on regenerative medicine will change the way the industry operates
in a great way. For example, cases, where patients will be administered risky
procedures which can compromise their safety, will be no more. The different
procedures administered in the field will be passed through several tests to
ensure they are safe before they can be marketed. It is unlike the current
situation where many clinics pop up with their developed procedures. Others can
even end up posing health concerns to users.
The service delivery in the industry will be faster. It will be made faster due to the fact
that the regulatory body will expedite the approval of different procedures
which can make it easy to treat different diseases. Experts in the industry
such as Cameron Clokie agree the industry has taken long before necessary
regulations are put in place. With the increase in the popularity of
regenerative medicine, the FDA regulations will come in handy.
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