As you most of the recipients of this information are aware, Puerto Rico and many other locations in the Caribbean have been devastated by the recent hurricanes Irma and Maria. Additionally, the area in and around Mexico City was substantially and negatively impacted by back-to-back earthquakes.
Rx-360 has received anecdotal reports from companies that many of the biopharma sites in Puerto Rico and Mexico City are not currently operating, and contact with employees in these regions has been difficult, if at all.
On Monday, Scott Gottlieb, FDA Commissioner, issued a Press Release indicating that with the significant presence of pharmaceutical suppliers in Puerto Rico, critically necessary drugs may result in shortages both in Puerto Rico and in other countries, including the USA mainland, that rely directly or indirectly on suppliers in Puerto Rico.
In support of its mission, Rx-360 has been in contact with FDA and members regarding the need for information to conduct reliable impact assessments related to these disasters. In service to our industry, Rx-360 is asking any organization that has a concern with the biopharmaceutical or medical device supply chain relying upon locations affected by these recent disasters, to submit NONCONFIDENTIAL information via this downloadable Disaster Recovery Information Spreadsheet. There are three short categories of information we seek: a. Submitter Information, b. Basic Site Information, and c. Basic Materials Information. After filling out this spreadsheet, please send it to email@example.com.
While you may provide additional comments in the Comments section, please again refrain from providing any confidential information.
Additionally, the FDA has informed Rx-360 that in addition to whatever information we can collect, it wants to hear directly from any company having an urgent supply chain concern in Puerto Rico via CDERPASE@fda.hhs.gov