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10/06/2014

Misdirected Anger With the FDA Commissioner’s Rather Perfunctory Role?

The September 24, 2014, issue of USA Today carried a story titled,
Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies
Policies Have Led to Epidemic of Painkiller Abuse.
The first sentence of the news
report says: “Anti-addiction activists are calling for the Food and Drug
Administration’s top official to step down, saying the agency’s policies have
contributed to a national epidemic of prescription painkiller abuse.” ABC News
reported the story that same day with the lead, “Anti-Addiction Groups Call for
New FDA Chief.
In the written ABC News
commentary, the hype may be characterized in one inflammatory sentence: “In a
letter released Wednesday, more than a dozen groups ask the Obama administration’s
top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has
led the agency since 2009. The FDA has been under fire from public health
advocates, politicians and law enforcement officials since last October, when
it approved a powerful new painkiller called Zohydro [ZOHYDRO™ ER (hydrocodone bitartrate)
extended release capsules, Zogenics, Inc.)],
against the recommendation of
its own medical advisers.” Both the print and newscast reports came from an
Associated Press report written by Matthew Perrone about a controversy that has
been brewing for sometime.
The activists’’ letter to
Secretary of Health and Human Services Sylvia Burwell is available online and
states their position clearly. 

Unfortunately, it may be that the
activists think that the FDA Commissioner has more of a discretionary role in
the matter than she actually does. It may be extremely difficult for a
governmental official to make a decision that doesn’t offend someone or some
group. But the
FDA is charged with “protecting the public health by assuring
the safety, effectiveness, quality, and security of human and veterinary drugs,
vaccines and other biological products, and medical devices.” If ZOHYDRO™ ER is a safe and
effective, quality product when used as approved, why shouldn’t the FDA allow
it? Just because it may a very potent narcotic and not come in an
anti-addiction formuation seem unreasonable standards.

Moreover, there are other checks and
balances that operate when citizens perceive that the FDA Commissioner has made
a “bad” decision concerning products like ZOHYDRO™ ER, rather than call for her
dismissal. First, the drug is a controlled substance. It can be “rescheduled”
by action of the Attorney General. Second, Congress can suggest that it be
removed from the market. Third, almost all states have their own controlled
substances or dangerous drugs legislation that parallel the federal Controlled
Substances Act as amended. The states can classify controlled substances in
such a way to limit the availability of ZOHYDRO™ ER more than does the federal
government. And lastly, isn’t this really a prescriber problem rather than a
drug product problem? Just because the FDA approved ZOHYDRO™ ER does not negate
the fact that a physician or other practitioner has to prescribe it to make it
available to ultimate consumers. If physicians are over-prescribing narcotics
and patients are diverting these medicines, is this really the fault of the
FDA? Why not help physicians and other practitioners and patients better
understand how to use these products appropriately rather than just remove them
from the market?

Honestly, will not allowing ZOHYDRO™
ER really impact the availablity or unavailablity of narcotic pain medicines
that much in today’s climate? The narcotic overdose deaths problem is bigger
than the FDA.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.

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