Finally! FDA holds public review on OTC plan
The meeting comes as a significant advancement in the FDA's long-standing plan to overhaul the OTC drug system.
According to the Administration, the review will include a critical examination to define whether and how to modernize its processes and regulatory framework.
On the matter of the long awaited meeting, Director of FDA's Center for Drug Evaluation and Research Dr. Janet Woodcock says it’s time as “the current system isn't working well for the public or for us."
Challenges associated with the current OTC drug review process is that it has not changed in more than 40 years.
Under the spotlight to make a decision on..
In its hearing, the Administration aims to examine streamlining the monograph process to mimic the device reclassification process put in place by the Food and Drug Administration Safety and Innovation Act. Under this proposed process, monographs could be established by administrative order, after issuance of a proposed order for public comment.
It will also look at issuing regulations to require product-specific information and expand the use of guidance that could require sponsors to submit limited information about individual products prior to marketing. This could be similar to, but less detailed than, a new drug application (NDA).
Finally, the FDA will look at the NDA deviation process and question why industry has not utilized this option and seeks input as to whether this process could be improved to increase utilization.
Currently a sponsor applies for this deviation by showing that the product complies with all the conditions of a monograph except for the deviation, and provides FDA adequate data to demonstrate the safety and effectiveness of the product with the deviation.
Industry is awaiting sunscreen ruling
The FDA has been feeling the heat from all sides of the industry of late, particularly in the area of approving what are widely thought to be the latest safe and effective sunscreen products.
Eight pending sunscreen applications have yet to be approved, backlogged for over a decade.
The delays in approvals have even caught the attention of Congress and bipartisan legislation will be introduced to reform the sunscreen application process in the very near future.
Sunscreen approvals also fall under the OTC monograph process.