Shortages of drugs and saline produced in Puerto Rico are beginning to materialize after hurricanes Irma and Maria wreaked havoc on production on the island, which produces about 10% of the U.S. drug supply including products like Lipitor and blood thinner Xarelto.
The FDA has said that there are about 40 drugs manufactured in Puerto Rico, 13 of them exclusively, and that shortages of some of those will be materializing within days. The storms knocked out power, and while manufacturers have backup generators, they could be without commercial power for months. Most of the facilities that have resumed production, maintain only partial operations, the FDA said.
“New shortages could result from these disruptions and shortages that existed before the storms could potentially be extended,” FDA Commissioner Scott Gottlieb said in a statement.
In fact, on Tuesday, Newark, California-based Depomed said that patients could expect disruptions in the supplies of pain drug Nucynta ER, which is manufactured in Puerto Rico by its third party manufacturing partner, an affiliate of Janssen, from which it bought U.S. rights to the drug. Janssen, which sells the drug outside of the U.S., didn’t respond to a request for comment.
Depomed said it didn’t expect any significant disruption to the supply of the immediate release version of the Nucynta, saying it has recently transitioned production of it to a new third party manufacturer. While its nerve pain drug Gralise is produced in Puerto Rico by CDMO Patheon it said it believed it had adequate inventory to avoid a disruption in supplies. A spokesperson for Patheon, now owned by Thermo Fisher Scientific, said in an email that the company is "making considerable progress in bringing our site back to full capacity."
Saline solution was already suffering supply restraints before the storms knocked out power to plants across island, including three plants where Baxter International makes a range of products from premixed injectables to products used in the delivery of medications, including small volume presentations of sodium chloride.
The company has said it lost days of production as a result of the storms but is making progress restoring capacity. A spokesperson in an email today said as a Baxter had moved supplies of some products off the island before the storms hit.
None of Baxter's large-volume production was affected by the storm, the company said. But Baxter has put customers on allocation of sodium chloride and will try to make up for some of that lost supply by importing small volume saline and glucose from plants in Australia (PDF) and Ireland (PDF).
More shortages are sure to materialize. According to a report from Healthcare & Life Sciences Review (PDF), Puerto Rico is base for about 50 FDA-approved drugmaking facilities. Those include facilities owned by some of the largest drugmakers, like Pfizer, Merck & Co., Eli Lilly, Bristol-Myers Squibb and Amgen, as well as and Johnson & Johnson’s Janssen unit. Products produced on the island include blood thinner Xarelto and the cholesterol drug Lipitor.