Tell the FDA Their New Compounding Rules Will Hurt Patients

Under new rules proposed by the FDA, there will be an approved list of “bulk ingredients” (drugs) the FDA will allow to be sold by compounders in outsourcing facilities. Anyone can nominate bulk ingredients for the list (pharmacies are expected to be the most likely to do so), but the FDA is requesting supporting data for any ingredient nominated—and the new rules for this supporting information are so broad and complex, requiring so much time and research, that smaller organizations will find it difficult or even impossible to meet the agency’s requirements.

Tell the FDA that their terms of the request for nominations for bulk substances are entirely too broad, and will greatly diminish patients’ access to important medications.

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Food and Drug Administration (FDA)

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Dear [Decision Maker],

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I read with interest the FDA's proposed rule for additions and modifications to the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Unfortunately, these new rules will severely diminish my access (and the access of countless Americans) to many compounded medications. The supporting information you are requesting for each ingredient is so broad and complex, requiring so much time and research, that smaller organizations will find it difficult or even impossible to meet your agency's requirements.

For example, you are asking nominators to come up with an estimate of the size of the population that would need this compounded drug product. That is tantamount to saying there must be an existing market for this product and it must be of some size. This means that new products, or old products that might prove useful in new ways or for new populations, might be barred. What is particularly troubling is the implication that unless there is a large enough group of people who need a compounded medication, the answer will be an automatic No.

When did we as a nation decide that we no longer care about individuals' needs? If a compounder is willing to make a medication for an individual patient, what business is it of the federal government? Since traditional compounders can't ship more than 5% of their product across state lines, prohibiting outsourcing facilities from selling to individuals or very small populations means a lot of people won't be able to get a medication they really need.

"General or boilerplate statements regarding the need to compound from the bulk drug substance or the benefits of compounding generally," your rule notes, "will not be considered sufficient." In other words, the nominator must go through this painstaking information-gathering process for each and every bulk ingredient and compounded drug product. With these new proposed rules, the info required by your agency has changed -- which places an intolerable burden on compounders.

It can even be argued that your new rules interfere with the practice of medicine, since physicians are in the best position to determine the extent of patients' need, not the FDA. My understanding is that legally, your agency is not supposed to do that. The practice of medicine is supposed to be regulated by states, not the federal government.

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

Protecting Natural Health