2004N-0166 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Feeding Practices Study II
FDA Comment Number : EC4
Submitter : Ms. Lisa JOnes Date & Time: 06/10/2004 04:06:07
Organization : Madigan Army MEdical Center
Health Professional
Category :
Issue Areas/Comments
1)Suggest data collection be done by an independent contractor and not by formula manufacurer. Contractor should not have any affiliation with formula industry or its parent drug company.
2) Suggest formula manufacturers be required to identify to the public when "new" additives are under FDA testing period or under just a GRAS apporval ( informed consent). Fines should be set for failure to comply or misleading ads that state "FDA Apporoved"
3) Formula manfacturers should be regulated to restrict their ability to produce only formula containing these " new" additives and access to non additive formula should still be available to health care facilities and families to enable the choice not to be part of a "study", "trial" etc. Especially for the bedside physician. Formula manufacturers should NOT continue to be given the "right" to choose how they want infants fed. The bedside physician should always be able to make a clinical decision on whether or not a "new" formula is suitable for their individual patient.
4) Especially within the NICU population. Additives should not be intoduced across the board based on studies funded by formula manufacturers. As with the recent DHA/ARA- studies were resticted to populations that are NOT the general norm for the NICU, excluding most of the standard NICU population yet the change was made that affected ALL NICU infants.
5) Formula manufacturers should not have the ability to introduce "new" formulas into the hospital settings without administrative and medical approval. With the latest DHA/ARA formula, many reps actively removed the non additive product and replaced with the additive product without any contact or approval of the administation or medical chiefs. Again, medical providers should always retain the clinical right to choose not to use a changed product. Especially on that is still under study.