FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico

FDA Commissioner Scott Gottlieb released a statement on Oct. 13, 2017 detailing the agency’s work to help prevent a shortage of Baxter’s sodium chloride 0.9% injection bags, which are manufactured in Puerto Rico. Lack of availability of the product, already in short supply prior to the destruction brought by Hurricanes Irma and Maria, could put the health of US citizens at risk, Gottlieb stated.

The company’s plants in Puerto Rico manufacture small-volume parenterals used primarily in drug compounding. Baxter stressed in a press release that large-volume sterile solutions are not produced in Puerto Rico and are, therefore, not impacted. According to Baxter, the company’s three manufacturing sites in Puerto Rico “sustained minimal structural damage” and limited production activities had resumed as of October 12. The company is using diesel generators to power its facilities and using satellites to restore communications.

In preparation for the hurricanes, Baxter had moved some finished product off of the island. After the hurricanes, it has been working with FDA and states it has been “granted regulatory discretion for temporary special importation of certain products from Baxter facilities in Ireland and Australia to help support product supply for the US market.” FDA has also helped the company to restore its operations and move product off of the island.

“While these actions will help mitigate some of the projected shortfall in supply, they will not be adequate to fully bridge the gap in the near term. Baxter will continue to do everything it can to ramp up production in Puerto Rico in the weeks ahead and, with the support of special importation granting from FDA, continue to utilize its other facilities to help address product demand in the United States,” the company stated in a press release.

In addition, FDA is helping to secure fuel and manufacturing supplies, and Gottlieb assures the public that the agency will continue to work to secure the drug supply chain. “FDA and Baxter will continue to keep in close consultation as we monitor the challenging situation on the island. The agency is also continuing its work with other manufacturers on steps to prevent or mitigate shortages of other types of critical medical products … FDA is also expediting reviews and approvals of other dosage forms and generic versions of products as alternate sources of critical products. Above all else, we at FDA remain fully committed-for the long run-to the people of Puerto Rico to help them recover from this tragedy,” Gottlieb stated.

Baxter is helping their employees affected by the storms by providing food, gas, and water and setting up a relief fund. “The devastation of Hurricane Maria is heartbreaking and tragic,” said José (Joe) E. Almeida, Baxter chairman and CEO, in the press release. “I met recently with many of our dedicated employees in Puerto Rico, and I am both inspired and humbled by their commitment to our mission, our patients, their communities and each other in the face of the unimaginable damage and loss they’ve experienced. Our mission to save and sustain lives calls on us to give back in times of crisis; Puerto Rico has our support.”

Sources: FDA and Baxter