Tell the FDA to Obey the Law and Hold Public Hearings!

The FDA’s Compounding Advisory Committee may be in the process of removing adenosine monophosphate (AMP) and other compounds from the market illegally—without any public comment period. Normal procedure dictates that any new inclusion on the committee’s Withdrawn or Removed list requires a proposed rulemaking so the public and other stakeholders can weigh in, but no such rulemaking has been proposed, leaving no option for the public to voice their concerns. Apparently the FDA views public involvement on these matters as an unnecessary roadblock.

Tell the FDA that it must not illegally remove important treatments from the market without first going through a formal, public process. The public has a right to voice concerns about losing access to important treatments.

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Stephen Ostroff

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Obey the Law -- Hold Public Hearings on Additions to the Withdrawn or Removed List!

Dear [Decision Maker],

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I understand the FDA's Compounding Advisory Committee is considering remove adenosine monophosphate (AMP) and other compounds from the market -- illegally, without any public comment period.

AMP is made naturally in every cell of the body as a byproduct of the metabolic process. When injected intramuscularly, the body converts AMP to ATP (adenosine triphosphate, the "energy molecule" which is produced by our cells' mitochondria), and where it is used as an immediate and safe form of energy. AMP is used by doctors for any number of important purposes, from an effective treatment for multiple sclerosis, to relief from chronic fatigue and muscle fatigue. Given the multiple uses and benefits of this treatment, why would the FDA seek to remove AMP from the market?

Normal procedure dictates that any new inclusion on the committee's Withdrawn or Removed list requires a proposed rulemaking so the public and other stakeholders can weigh in, but no such rulemaking has been proposed, leaving no option for the public to voice their concerns. Apparently the FDA views public involvement on these matters as an unnecessary roadblock.

Last year, your agency proposed that future additions to the Withdrawn or Removed list not go through the rulemaking process at all, shutting out the public from having any input regarding which compounds are added to the list. This strikes me as frankly underhanded. The proposed rule to eliminate the public from this process has not yet been finalized, so I believe your agency is legally required to respond to public comments on the rule and issue a revised, proposed final draft of the rule.

Please preserve consumer access to AMP -- but even more importantly, the public has a right to voice their concerns about losing access to important treatments. Obey the law, and hold public hearings on additions to the Withdrawn or Removed List!

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]