Interdisciplinary teams of Duke University graduate students within the SciReg Lab submitted formal comments to the Food and Drug Administration (FDA). These comments were issued in response to recently-released draft guidances regarding homeopathic drugs and drug products containing nanomaterials. These comments (accessible here: homeopathic drugs; drugs containing nanomaterials) are now in the public record.
On December 20, 2017, the FDA published a draft guidance for industry and FDA staff called "Drug Products Labeled as Homeopathic" (82 FR 60403). The FDA says this nonbinding document describes the agency's intentions for prioritizing enforcement and regulatory actions for drugs labeled as "homeopathic" that have been marketed in the US while lacking FDA approval. As the FDA admits, the agency has a legal mandate to approve homeopathic-labeled drugs but has not historically reviewed any such drug products. The new guidance represents the FDA's updated thinking on how to regulate homeopathic-labeled drugs, particularly by applying a risk-based enforcement approach.
In their comment, a team of six students expressed their general agreement with and support of the proposed risk-based framework, but also argued that the FDA did not consider the users of homeopathic drugs and the risks associated with certain populations. The students urged FDA to broaden their proposed definition of "vulnerable populations", as used in the guidance, to include socially vulnerable populations as indicated by social determinants of health. These social determinants, as defined by the World Health Organization, are the broad structural conditions of daily life that have strong influences on a person’s health outcomes, and include conditions like the unequal distribution of resources and income. The students acknowledge, however, that basing risk considerations on these social determinants of health requires extensive data on the demographics and use patterns of individuals taking homeopathic drugs—and that such data do not widely exist.
Drugs Containing Nanomaterials
On December 18, 2017, the FDA published a draft guidance for industry called "Drug Products, Including Biological Products, That Contain Nanomaterials" (82 FR 60019). The FDA says this nonbinding document communicates the agency's current thinking on specific principles and considerations for developing human drug products that contain nanomaterials in the final drug form. The agency emphasizes that the guidance does not intend to limit or regulate the use of nanomaterials, but instead aims to facilitate future evaluations of nanomaterial-containing drugs on the bases of safety, effectiveness, performance, and quality. The FDA requested comments on the draft guidance as a whole, and on the specific terminology used throughout the document, including the term "nanomaterial."
In their comment, a team of five students provide analysis and recommendations to the FDA in four areas:
- Characterization of Nanomaterials: The students recommend a revised definition of "nanomaterials" to better align with international definitions and to clearly communicate a difference between naturally-occurring and engineered nanomaterials.
- Risk Factor Testing and Regulation: The students recommend assessments of physical characteristics and surface characteristics of nanomaterials, and request better guidance from FDA in terms of reporting potential immunogenicity.
- Data Reporting Regulation: The students recommend the FDA take an active role in standardizing the various routes for reporting critical attributes of a nanomaterial, and recommend FDA create a central, public registry with this information.
- Environmental Impact of Nanomaterials: The students recommend that the FDA include language in the guidance regarding the disposal of nanomaterial drugs, especially if those nanomaterials have potential environmental or ecotoxicological impacts, and urge FDA to adopt a life cycle analysis approach when assessing a new nanomaterial-containing drug. Additionally, they suggest that in most cases FDA require environmental assessments for all drugs containing nanomaterials prior to approval.