On November 12, 2014, the FDA responded (here) to a September 23, 2014 correspondence to Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research and also submitted the same to Docket No. FDA-2012-P-0566 regarding the safety of PEG 3350 for pediatric patients. The big debate is a bit broader than just pediatric safety; it involves an Agency determination stating that, when a product is completely switched from prescription to OTC status, the product can no longer be marketed by prescription.
The case in point here is Miralax, once a prescription only product, is now available only as an OTC; other generic equivalents were approved as ANDAs for prescription use only. The generic manufacturers have for years argued that there were leave-behind Rx indications and uses that would permit the continued marketing of the prescription product. FDA disagreed and has begun the process to remove the prescription versions from the marketplace.
Without rehashing the entire argument (which, by the way has been a bone of contention between the industry and the Agency for years and for many other products) a final decision is in the offing (at least for this product). The FDA response noted above contains a comprehensive evaluation of its decision making process in its Proposed Final Notice that was appended to the response. The advance release appears to be a bit unusual, but nonetheless very informative.
Now that the FDA has outlined its legal and regulatory rationale for its position on this specific product, I am certain that legal experts will be parsing the wording in the Final Notice looking for ways that they can assure that life cycle management of future Rx to OTC switches can be most successful for their clients and generic applicants can be looking for ways to continue marketing approved prescription versions for as long as they legally can.
