Pharma Gives Update on Puerto Rico Manufacturing Operations

AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
Sep 28, 2017
By BioPharm International Editors

Pharma companies including AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb (BMS), and Eli Lilly and Company have provided updates on their respective pharmaceutical manufacturing operations in Puerto Rico in light of the impact from Hurricane Maria, which hit the island on Sep. 20, 2017.

AbbVie

AbbVie said in a company statement issued on Sep. 25, 2017 that its pharmaceutical facilities, which are running on independent power generators, remain intact and operational, with teams working to restore normal operations. The company’s manufacturing network is designed to provide multiple and redundant channels of product supply, and it has managed inventory to assure availability of medicines to patients.

“No patient impact is expected as a result of Hurricane Maria,” the company said in its statement.

AbbVie is in the process of confirming the safety of its colleagues and their families in Puerto Rico and the Caribbean, an effort that remains ongoing because power outages have impacted communications across the islands. The company and the AbbVie Foundation have committed more than $2 million to hurricane disaster relief and to help Mexico recover from damage done by the September earthquake. AbbVie is working with partners to evaluate the need for additional support. The AbbVie Foundation will match employee contributions to organizations in support of relief efforts. The company is working with nonprofit partners throughout the affected regions on a multitude of relief activities, including patient access to medicines.   

“The safety of the more than 1200 AbbVie employees and their families in Puerto Rico is a primary concern for AbbVie, and we continue to provide assistance where needed. Our employee disaster assistance program is available to help meet employees’ immediate needs as recovery continues across the region,” said the company in its statement.

Amgen

Amgen’s outreach to its impacted staff of more than 2000 and their families is ongoing as well. "The [c]ompany's preliminary assessment is that the critical manufacturing areas in our facility in Juncos, Puerto Rico, have not been significantly impacted by this storm," said Esteban Santos, executive vice-president of Operations at Amgen, in a company press release issued on Sep. 25, 2017. "We expect to maintain our long-term track record of reliably supplying our patients with the medicines they need."

“No product nor in-process inventory has been lost, and consistent with the [c]ompany's long-standing practices, the inventory maintained by the [c]ompany and its global distribution network is sufficient to meet patient demand,” Amgen stated in its press release.

The company has backup generators powering its Juncos site and is working with its onsite staff to return operations in Puerto Rico to normal as quickly as possible. In addition, the company has manufacturing capacity at other sites around the world. The company reaffirmed its 2017 guidance following an initial review of the storm’s impact.

The Amgen Foundation has pledged $3 million to support Hurricane Maria relief efforts in Puerto Rico and has committed up to an additional $2 million for longer-term rebuilding efforts. Amgen has also activated its Staff Disaster Relief Fund to aid staff on the island, including financial assistance for shelter, medical attention, clothing, and other critical relief. The Amgen Foundation will also match donations made by Amgen staff around the globe who wish to contribute their own funds to the relief efforts resulting from Hurricanes Maria, Irma, and Harvey, as well as the earthquakes in Mexico.

AstraZeneca

In a statement emailed by AstraZeneca on Sep. 27, 2017, the company said it is still receiving updates regarding the status of its plant in Canovanas and its employees. “Our number one priority is ensuring the safety and health of our employees and their loved ones. And we are still in the process of formally assessing our manufacturing facility in Canovanas; however, we believe that given the magnitude of the storm, the facility fared well,” the company stated.

“A storm crew has been in limited operation at our manufacturing site, and this will continue until employees can safely return to work and our facility has been formally assessed. We understand that this is a critical time for our employees to be safe and with their families in their time of need, and our efforts to resume full operations are dependent on their safety, as well as other factors regarding the infrastructure of the island,” the company said in its statement.

The Canovanas site currently manufactures the anti-cholesterol drug Crestor (rosuvastatin), with a smaller operation on several other legacy products. In advance of the storm, the facility took appropriate precautions, and business continuity plans are in place to ensure that medicines continue in production and can be provided to patients in need. Although this site is of critical importance to the company, AstraZeneca has other manufacturing facilities worldwide.

“We don’t anticipate any impact in production or supply at this time. We remain committed to our facility in Puerto Rico and we will work diligently with both our employees as well as the appropriate resources on the island to resume operations as soon as its appropriate,” the company said in its statement. 

The company has approximately 250 employees based in Puerto Rico. With communication on the island still limited, company managers are actively reaching out to stay close to, monitor, and offer assistance to employees in the region.

As part of the company’s regular commitment to aid in natural disasters, it is contributing products to its two non-governmental organizations—Americares and Direct Relief International—throughout the year. Additionally, as part of the company’s AZ&Me Prescription Savings Program, the company will be assisting patients currently enrolled in the program who are located in impacted areas with emergency refills of their medications.

Bristol-Myers Squibb

BMS is still assessing the full situation around its pharmaceutical operations in Puerto Rico. “The island of Puerto Rico has sustained significant damage, and our primary concern is with our employees, their families, and the citizens of Puerto Rico,” BMS said in an emailed statement on Sep. 27, 2017. 

The company is executing contingency plans to mitigate product supply risk as it assesses the situation on the island and is working to bring operations back online. The company is contacting employees to provide recovery support. In addition, the Bristol-Myers Squibb Foundation has committed an additional $1.5 million to its initial support of $250,000 (a total of $1.750 million) to assist its disaster relief partners working on the ground in Puerto Rico, according to the company.

Eli Lilly and Company

Lilly, which has two manufacturing sites in Puerto Rico, said that its sites had minimal damage and that this damage will not hinder operations. “Our inventory strategy for products is designed to be able to protect against this type of event, and we see no supply risk to patients at this time,” the company said in an emailed statement on Sep. 27, 2017.

“Our primary concern is the safety of our employees and their families. We are in regular contact with our plant managers, and they have contacted many of our employees. However, they are still trying to connect with some of them. It is challenging due to power and communications loss on the island,” the company said in its statement.

The Lilly Foundation recently announced a donation of $125,000 to the American Red Cross for immediate assistance following the hurricanes in Puerto Rico. The foundation now has committed an additional donation of $500,000 to assist with recovery efforts. On Sep. 24, 2017, Lilly flew an emergency shipment of insulin and supplies to the island in response to an urgent request from the country’s Department of Health. The shipment included 2400 insulin vials and pens, which will treat approximately 1000 people for 30 days. The shipment also included glucagon and emergency supplies for Lilly employees, including food, water, batteries, generators, and childcare items.

In related news, FDA Commissioner Scott Gottlieb, MD, issued a statement on FDA’s efforts to respond to the impact of Hurricane Maria in Puerto Rico and ongoing recovery efforts related to Hurricanes Harvey and Irma. In his statement, the commissioner said that FDA’s efforts are multifaceted, and that the agency has been working to provide recommendations and to communicate how to handle food and medical products that may have been impacted by the storms.

Source: Amgen, AbbVie, Astrazeneca, Bristol-Myers Squibb, Eli Lilly and Company, and FDA

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