FDA Commissioner Scott Gottlieb provided an update on the status of pharmaceutical operations in Puerto Rico.
Puerto Rico was devastated by the two powerful hurricanes Irma and Maria, with some of the population still without electricity and clean drinking water a month later. There is an additional concern beyond the direct humanitarian crisis: there is significant drug manufacturing capacity in Puerto Rico, and plant shutdowns could lead to drug shortages.
The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD recently made an agency statement, providing an update on the status of pharmaceutical operations in Puerto Rico.
“FDA continues extensive efforts to provide direct assistance to the residents of Puerto Rico following Hurricanes Irma and Maria, and is taking new steps to mitigate the impact of these twin disasters on the island’s vibrant medical product manufacturing sector. Our top priority is the people of Puerto Rico,” Gottlieb said.
While the level of damage varies from site to site, all pharmaceutical plants, including those with only minor damage, are still running on generator power, according to Gottlieb. It may take months before stable power supplies are restored and manufacturers can access commercial power. With the use of generators, some sites have re-started production, but others have not. For those that have begun production again, most are only running parts of their plants.
According to data from the Bureau of Economic Analysis, the pharmaceutical products manufactured in Puerto Rico make up nearly 10 percent of all drugs consumed by Americans. “New shortages could result from these disruptions, and shortages that existed before the storms could potentially be extended,” Gottblieb said. “We’ve been in touch with all the firms. In the case of products we’re most concerned about, FDA leadership is in contact with senior management teams.”
Recovering its medical product manufacturing base will be vital to the overall recovery of Puerto Rico. The pharmaceutical and biological drug products and medical devices produced on the island account for about 30 percent of Puerto Rico’s gross domestic product, according to FDA.
In addition, the agency notes that approximately 80 percent of the drug products manufactured on the island are consumed by U.S. citizens in Puerto Rico and across all fifty states. “Securing this manufacturing base is vital to maintaining access to many important medical products,” Gottlieb stated.
FDA is tracking approximately about 40 pharmaceutical and biological drug products for which a shortage could have a “substantial impact” on the public health. This number is expected to shrink as the agency learns more about the supply chains for each product and more steps are taken to restore production in Puerto Rico, according to Gottlieb.
“In some cases, we’re in daily communication with the companies to stay on top of the evolving challenges and to act quickly when we can to prevent drug and device shortages. 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,” said Gottlieb.
He added that “The FDA remains committed to Puerto Rico’s future. Everyone is dedicated to these relief efforts. Last Friday I visited with FDA’s staff in San Juan. I was moved by their courage and commitment. I’m also inspired by the work of everyone assisting this relief effort from our White Oak, Maryland headquarters. This will be a long recovery. The devastation was significant. But we’re in this for the long run. We’ll continue to partner with the people of Puerto Rico to help them recover and secure their economic future.”