Hurricane Devastation Impacts Health Care Supply Chains

The destruction caused by Hurricane Maria in Puerto Rico last month has created major disruptions for the island’s pharmaceutical product and medical device manufacturing facilities. Days of interruption and damage to manufacturing plants are affecting international supply chains for products such as cancer and HIV treatments, immunosuppressants for patients with organ transplants, and small-volume bags of saline, which are necessary for patients who need intravenous solutions.

Puerto Rico is the fifth-largest territory in the world for pharma manufacturing and produces about half of the world’s top-selling patented drugs, according to a 2016 report from Pharma Boardroom. Short-term economic losses are being estimated, while concerns persist about the storm’s long-term effect on employees’ abilities to travel to work, the safety and efficiency of the machinery used and the ability to keep the facilities running on generators. In a statement issued by the Food and Drug Administration (FDA) on Oct. 6, Commissioner Scott Gottlieb detailed plans to help Puerto Rico recover its medical product and manufacturing base, which he said “are a key component of the island’s economic vigor.”

“[..]even the facilities that sustained relatively minor damage are running on generator power. They could be without commercial power for months…Moreover, most of the facilities that we know of, that have resumed production, maintain only partial operations. New shortages could result from these disruptions and shortages that existed before the storms could potentially be extended.”

Citing data from the Bureau of Economic Analysis, Gottlieb said that pharmaceutical products manufactured in Puerto Rico “make up nearly 10% of all drugs consumed by Americans. And that doesn’t even account for medical devices.” He noted that the FDA is keeping a close watch on about 40 critical pharmaceutical and biological drug products which, in the event of a shortage, “could have substantial impact on the public health.”

He added, “In urgent cases, when critical products are at issue, we’ve intervened over the last two weeks to help firms secure fuel to maintain production lines, get clearance to move logistical support into the island or finished goods to their recipients.”

The Washington Post reported that more than four dozen FDA-approved drugmaking facilities are in Puerto Rico, including ones owned by Pfizer Inc., Merck, Eli Lilly, Johnson & Johnson, Bristol-Myers Squibb and Amgen. Baxter International Inc., which the Post cited as being the “dominant player” in the IV market, issued a statement acknowledging the impact of the storm on its operations:

Our sites sustained minimal damage, and we’ve initiated limited production activities in all of our facilities. In addition, we are examining all opportunities to leverage Baxter’s global manufacturing network as we continue efforts to restore operations in Puerto Rico.

As it relates to product supply, in advance of the hurricanes, we implemented our hurricane preparedness plan to help mitigate potential impact. We have also been delivering products to customers in Puerto Rico to help address patient need on the island. And we are continuing to proactively communicate with our customers the actions we are taking to minimize potential disruptions, including closely managing product inventory.

Not all facilities have suffered damage, however. Amgen announced on its site that back-up generators are powering its Puerto Rican site and that, “No product nor in-process inventory has been lost, and … the inventory maintained by the Company and its global distribution network is sufficient to meet patient demand.”

Jones Act Waiver Granted for Puerto Rico

A request to temporarily waive the Jones Act for Puerto Rico that was denied on Monday has been approved. President Donald Trump waived shipping restrictions on Thursday to help speed up fuel and supply deliveries to Puerto Rico, devastated by Hurricane Maria, the White House said.
Maria wiped out power on the island and destroyed infrastructure and cell towers, leading to massive shortages. Even though a waiver had been granted to Texas and Florida after Hurricanes Harvey and Irma, the Department of Homeland Security initially said there was no need to waive the restriction for Puerto Rico, as it would not address the issue of the island’s damaged ports.

The Jones Act, or the Merchant Marine Act of 1920, was initiated almost 100 years ago to keep foreign-flagged vessels from shipping fuel and goods between U.S. ports. The last previous waiver was in December 2012 to allow petroleum products to be delivered for relief assistance after Hurricane Sandy.

Sen. John McCain, R-Ariz., disagreed with the initial decision to deny suspension of the act for Puerto Rico. He wrote to the Department of Homeland Security urging it to allow a waiver and ultimately “a full repeal of this archaic and burdensome act.” Without the waiver, McCain said residents of Puerto Rico would end up paying at least twice as much for food, drinking water and other supplies.

Supporters of the Jones Act, including ship builders, have maintained that it supports American jobs, including jobs in Puerto Rico and keeps shipping routes reliable, according to Reuters. They also contend that the issue in Puerto Rico is distributing shipments across the island once they are delivered.

The temporary waiver was not a surprise, as Puerto Rico Gov. Ricardo Rossello said on Wednesday that he expected the federal government to suspend the Jones Act. He said he had been speaking with members of Congress from both parties who supported an emergency waiver.