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The Food and Drug Administration is concerned about potential shortages of life-saving drugs made in Puerto Rico after hurricane Maria nearly shut down the U.S. territory’s economy.
The island is home to dozens of drug and device manufacturing facilities that produce pharmaceuticals to treat conditions including cancer, HIV, high cholesterol, blood clots and arthritis as well as devices for people with diabetes.
There have been efforts to prevent or limit the loss of drugs vital to U.S. patients because of challenges involving refrigeration, storage and transportation, according to a statement from FDA Commissioner Scott Gottlieb released Sept. 25. A hurricane shortages task force was also created to find potential issues and solutions.
“This critical work included clearing debris to reach facilities; assessing fuel needs to keep generators running; and securing permissions to allow planes to land in Puerto Rico and fly critical products to the continental United States,” according to the statement.
The 9NEWS Verify team reached out to affected pharmaceutical companies to find out if there will be a national drug shortage as a result of the damage wreaked in Puerto Rico.
PHARMACEUTICALS IN PUERTO RICO
Puerto Rico might be a small island, but it has a significant impact on the pharmaceutical industry – it is home to more than 500 medical product facilities.
“It is the fifth largest territory in the world for pharma manufacturing, and in recent years has significantly ramped up its capabilities for research and development, and medical and diagnostic devices as well,” according to a report released last year by the PharmaBoardroom, an organization that provides free reports about pharmaceutical trends around the world.
The report provided the following statistics:
- 12 of the top 20 pharmaceutical companies manufacture in Puerto Rico
- 13 of the top 20 medical device companies manufacture in Puerto Rico
- 50 percent of the world’s leading pharmaceutical companies operate in Puerto Rico
- 13 of the 20 top-selling patented drugs are manufactured in Puerto Rico
Since pharmaceuticals make up nearly two thirds of Puerto Rico’s manufacturing output and a quarter of Puerto Rico’s GDP, the island’s economy largely depends on the industry.
Puerto Rico’s pharmaceutical industry is responsible for almost 90,000 jobs, which are essential for recovery and rebuilding, according to the statement from Gottlieb.
The FDA provided the following information in an update on Sept. 28 about its hurricane response efforts:
- More than 20 firms have medically important FDA regulated products
- More than 40 high-priority drugs were identified - their continued availability is essential and short-term disruptions could lead to shortages
- The FDA is currently working with at least five companies affected by the hurricane to prevent shortages of medical products in both Puerto Rico and across the U.S.
Nearly $15 billion a year is at stake in Puerto Rico, according to the Bureau of Labor Statistics.
SUPPLY RISK LEVEL BY COMPANY
As Gottlieb stated, the situation is evolving – so Verify followed up with the following pharmaceutical companies Nathan Bomey of USA Today reached out to in September.
Only two of seven companies responded to 9NEWS on Thursday. AstraZeneca and Pfizer sent us the same information about their supply they released in September.
We will update this story as we receive responses.
Here are the company responses to USA Today in September:
Bristol-Myers Squibb: The New York-based pharmaceutical giant said: "we are executing contingency plans that we believe mitigates product supply risk as we assess the situation on the island and work to bring our operations back online."
Eli Lilly: The Indianapolis-based company said it expects "no supply risk to patients at this time" after its sites experienced "minimal damage" and advance work helped prevent shortages.
"We have multiple internal and external manufacturing sites in our global network that manufacture our products, reducing the risk of supply issues due to a natural disaster," Lilly spokeswoman Tamara Hull said in an email. "We have contingency plans in place and will implement those if needed."
AbbVie: The pharmaceutical spinoff of Abbott Laboratories said that its Puerto Rico sites are running on backup power and employees are "working diligently to restore normal operations."
The company, which employs about 1,200 people in Puerto Rico, said it had "managed our inventory to assure availability of medicines to patients" and expects "no patient impact."
Amgen: The company expects "no interruption to patient supply," spokeswoman Kristen Neese said in an email.
AstraZeneca: The U.K.-based pharmaceutical company said it does not anticipate "any impact in production or supply at this time."
"We are still in the process of formally assessing the site, however, we believe that given the magnitude of the storm, the facility fared well," AstraZeneca spokeswoman Alexandra Engel said in an email.
Merck: The company said Monday that it was "still evaluating the potential impact on our operations."
"As in any unforeseen situation, we will work to minimize any potential impact to patients and customers," Merck said. "Continuity of supply of our medicines and vaccines has been and remains one of our highest priorities."
Pfizer: Pfizer said in a statement that "we have a healthy supply of finished goods" in hand and "we do not see a risk to patient supply at this point."
As of the end of September, there was not widespread concern about the potential for drug shortages among the major pharmaceutical companies as a result of the natural disaster in Puerto Rico.