Critical Drug Supplies May Be Limited Due to Puerto Rican Manufacturing
When Hurricane Maria ravaged Puerto Rico on September 20th — disrupting communications, power supplies, and travel across the island — the first thing that most people worried about was probably not an interruption in drug supplies. However, Puerto Rico is a major drug manufacturing center, and the impacts of this hurricane are being felt throughout the industry.
Why Puerto Rico Is So Important to Pharma
A recent article in the New York Times outlined the importance of Puerto Rico to the pharmaceutical industry. The island has around 80 manufacturing facilities that produce either drugs or medical devices (which are Puerto Rico’s largest export). Forbes also noted the vital role this area plays in drug manufacturing: 12 of the 20 largest pharmaceutical companies have facilities here and 7 of the top 10 best-selling drugs globally are made in Puerto Rico.
What Challenges Are Drug Manufacturers Facing?
The logistical challenges that companies with plants in Puerto Rico are facing are significant. In the New York Times article, reporters noted that these challenges include:
- Locating employees and helping them to get to work, which is difficult due to the highly damaged infrastructure (including roads and bridges)
- Acquiring enough diesel fuel to run the generators that currently power many of the plants
- Operating in an environment where power — and many of the phone lines — are down throughout the island
- Trying to return to a normal operating schedule while not diverting resources away from hospitals or other vital services needed in the wake of the hurricane
How Critical Is the Situation?
Information about the exact status of pharmaceutical facilities on the island has been sporadic and incomplete. However, according to PharmTech, the amount of damage to particular companies with operations in Puerto Rico has varied widely. In order to quell the confusion and rumors surrounding the pharmaceutical industry in the wake of Maria, some of the largest pharmaceutical companies released statements outlining their current status:
- Abbvie reported that they are running on independent power generators and that their facilities are intact; they do not anticipate an issue with their drug supplies due to the design of their network.
- Amgen released a statement to the effect that their Puerto Rican facilities were not severely impacted and that they have not lost any of their inventory. They also do not expect to have issues with drug supplies in the near future.
- Astra Zeneca was still in the process of receiving updates about its manufacturing plants, but believed that they had fared well. Their facilities are currently operating, but on a limited basis.
- Bristol Meyers Squibb noted that it was still in the process of assessment and of enacting plans to help reduce the risk of a decreased drug supply.
- Eli Lilly reported that its two plants on the island had only minimal damage and that they did not predict a drop in operations or a shortage of their pharmaceutical products.
- Merck has reported that they are still in the process of assessing the extent of the damage done to their facilities on the island.
- Pfizer has stated that they still have an adequate supply of their products and do not anticipate the shortage for their patients at this time.
For all the aforementioned companies, employee outreach remains a top priority, and many of the businesses have already pledged money to aid in the recovery efforts for the island.
Assessing the Aftermath for Drug Supplies
Despite the overall optimistic predictions of these companies, the Food and Drug Administration (FDA) has been concerned about disruption of drug supplies in the wake of Maria. “Some of the products are critical to Americans. A loss of access could have significant health consequences,” Dr. Gottlieb, the FDA Commissioner, told the New York Times. “We have a list of about 40 drugs that we are very concerned about.”
These drugs include methotrexate (used to treat childhood leukemia) and medications used to treat HIV. Humira and Xarelto, two other top-selling drugs, are also produced in Puerto Rico. This problem is made worse by the fact that 13 of these 40 drugs of concern are sole source — that is, they are only made by one company.
The FDA’s Drug Shortage Unit has been active since Maria struck and has been working closely with affected companies to help prevent a drug supply shortage. “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,” Gottlieb noted.
In short, Puerto Rico is of critical importance to the pharmaceutical industry. And while many pharmaceutical companies believe that there will not be an interruption in supplies, the FDA is concerned that many drugs that are important to the health of Americans may experience a supply interruption, which could impact public health.
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