Pharma Plants in Puerto Rico Gradually Resume Production

Tara Haelle

October 09, 2017

Approximately half of all pharmaceutical plants in Puerto Rico are at least partly operational, according to a Pharmaceutical Industry Association of Puerto Rico (PIA) official, dampening fears of drug shortages following Hurricane Maria's devastation in one of the most important pharmaceutical manufacturing centers in the United States.

"After Hurricane Maria, we had some interruptions in our production in basically all of our plants," Wendy Perry, PIA vice president and board member, told Medscape Medical News. "However, as of today [October 6], we have half of the plants already operating, some fully, some partially, but they're back on production. We expect the rest of the manufacturing plants to be up and running in less than a week."

Initial reports of the widespread destruction left behind by Maria led to concerns about "the potential for shortages of critical life-saving and life-sustaining drugs needed by patients on and off the island," according to a statement by US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD.

Puerto Rico is home to more than 500 facilities that manufacture biological, pharmaceutical, and medical devices for the island's residents, US states, and people across the world. Of those, more than 20 firms produce "medically important FDA regulated products," according to the FDA, including "cancer drugs, immunosuppressants used by transplant patients and devices needed for people with diabetes."

US citizens in Puerto Rico and in all 50 states consume an estimated 80% of the drug products produced on the island, according to the FDA. Nearly 1 in 10 of all drugs Americans use comes from manufacturing plants in Puerto Rico.

"More than 40 high-priority drugs have been identified," Dr Gottlieb's statement said. "Their continued availability is essential and short-term disruptions could lead to shortages, but FDA is working to mitigate any potential disruptions that could occur."

The biopharmaceutical industry also accounts for 30% of Puerto Rico's economy, so resuming operations as quickly as possible has become a top priority for the government, Perry said. Now that hospitals, nursing homes, and similarly high-priority facilities have been stabilized, the government has moved from acute emergency response to the recovery phase of managing Maria's impact, which involves regular meetings with top officials in the pharmaceutical industry.

"We have daily contact with the Puerto Rico Energy Authority, with the Secretary of Economic Development, and with the Port Authority," among others, Perry said. "We feel in control. Our emergency plans are in place, and we are confident that we are progressing, along with the government officials and all of the authorities that are needed, to ensure we will be able to supply the most needed medicines to the rest of the world."

Perry acknowledged that any failures in companies' emergency plans could place operations at risk in the medium to long term, but that does not appear to have occurred so far. Recovery progress varies at each company depending on the damage their facilities sustained.

"You can imagine the challenges following a category 5 hurricane," she told Medscape Medical News. "Some plants had very minor impact to the structures, some have medium, but they have been moving very fast to restore operations as soon as possible."

Repairs and Cleanup Underway            

Medscape Medical News reached out to more than two dozen pharmaceutical manufacturers on the island, but most were unavailable because of disconnected or busy phone lines. 

AbbVie reported on September 28 that its facilities "are running on independent power generation and are intact and operational, with teams working diligently to restore normal operations." The company did not have an updated statement at press time, but Adelle Infante, AbbVie's director of external communications, told Medscape Medical News that they "continue not to expect any patient impact as a result" of the storm's damage.

Patheon, part of ThermoFisher Scientific, reported having no infrastructure damage and is "taking every effort to return to a normal operating cadence," according to a statement provided by Mari Mansfield, Patheon's senior director of external communications.

"Last week the leadership and functional area heads conducted a thorough assessment of the site and an action plan was developed," the Patheon statement said. "Repairs and clean up are underway per that action plan. Leadership has initiated alternative shifts so employees have time to focus on both their needs and the site."

The company is focused first on ensuring that water, power, communication, and other utilities are functional and then "returning the site to operational readiness."

Another company that has at least called in its employees to start production backup is Amgen, according to Manuel Hormaza, managing director of IBS Caribe, a vendor that sells supplies to pharmaceutical companies. But information overall on when each company's facilities will resume full operation is limited, he told Medscape Medical News.

"These companies have a process that when they shut down, the startup is quite complex," Hormaza said. Some companies have multiple plants and have resumed production at some but not all of their facilities because inspections, cleanup, and other processes must occur before full production can continue.

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