Federal officials and major drugmakers alike are working to prevent national shortages of critical drugs for treating cancer, diabetes and heart disease, as well as medical devices and supplies, which are manufactured at 80 plants in hurricane-damaged Puerto Rico.

 

Puerto Rico has become one of the world’s largest centers for pharmaceutical and medical device manufacturing and its factories produce 13 of the world’s top-selling brand-name drugs. Indeed, pharmaceuticals and medical devices are the island’s leading exports, accounting for approximately $15 billion worth of business annually, according to a report from the U.S. Bureau of Labor Statistics.

 

In the devastation caused by Hurricane Maria, the country has struggled without electricity. Many large pharmaceutical companies report their factories didn’t sustain much hurricane-related damage, however most estimates calculate power isn’t likely to be restored to the island for three to six months. Although factories run by global pharmaceutical companies generally have backup power generation, locating enough diesel fuel for generators to run their factories is difficult; and employees are busy cleaning destruction in their neighborhoods, and so are unavailable to help resume manufacturing.

 

All of these factors in turn lead to considerable concern about possible national shortages of drugs. Some of these products are critical to Americans, Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, told the House Energy and Commerce Committee’s subcommittee on Health. A loss of access could have significant public health consequences, he explained.

 

“We have a list of about 40 drugs that we’re very concerned about,” Dr. Gottlieb told the committee.

 

Thirteen of the drugs, Dr. Gottlieb said, are “sole-source,” meaning the product is made only by one company. Those include HIV medications, injectable drugs and sophisticated medical devices, although he didn’t name the products. The biggest problem, he said, wasn’t damage to the factories, but the instability of the electric supply. Manufacturers are worried that a long-term lack of connection to a major power grid could jeopardize their products, and are also wary of relying on the more limited electrical grids that the territory is likely to activate as a first step to restoring power.

 

Several notable pharmaceutical and medical device companies said that while their plants lost power and were forced to shut down, they are coming back on-line using generators, so the companies don’t anticipate supply shortfalls. On the other hand, some companies have said the situation is precarious, an article in the New York Times reports.

 

The industry’s outlook, one may suspect, is presumably offered—at least in part—to reassure nervous shareholders. Nonetheless, that perspective does stand in contrast with the concern expressed by Dr. Gottlieb.

 

“We know that the grid is going to be unstable for a long period of time,” Dr. Gottlieb said. “The generators were never meant to operate for months and months on end.”

 

Erin Fox, a drug shortage expert at the University of Utah, told NYT she and other hospital pharmacists are monitoring the situation in Puerto Rico, and are worried the storm’s impact could exacerbate the U.S.’ already critical shortage of some drugs. Compounding the situation is that companies generally don’t disclose where they manufacture their drugs because it’s considered a trade secret, Fox notes.

 

“Because we have no transparency around that,” Fox says, “it’s actually hard to know the true impact of this [situation on the pharmaceutical and medical device supply chain].”

 

What are your thoughts or concerns about the pharma and medical device supply chain in Puerto Rico? If it does take several months for power to be restored, what impact will there be on pharmaceutical companies, particularly those which rely on consistent refrigeration for their products?