Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued assistance following the natural disaster in Puerto Rico.
Editor’s Note: The FDA reports that pharmaceutical and biological drug products and medical devices produced on the island account for about 30 percent of Puerto Rico’s gross domestic product. Roughly 80 percent of the drug products manufactured on the island are consumed by U.S. citizens in Puerto Rico and across all 50 states. Pharmaceutical products manufactured in Puerto Rico make up nearly 10 percent of all drugs consumed by Americans. On Friday, FDA Commissioner Scott Gottlieb issued a statement and an update on the critical situation facing the island.
“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.
As part of that commitment, FDA has an important mission to help Puerto Rico recover its medical product manufacturing base. These facilities are a key component of the island’s economic vigor. The pharmaceutical and biological drug products and medical devices produced on the island account for about 30 percent of Puerto Rico’sgross domestic product. Moreover, about 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.
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. And that doesn’t even account for medical devices. Puerto Rico is vital to the health and wellbeing of all Americans.
Some of these facilities were hit harder than others. But even the facilities that sustained relatively minor damage are running on generator power. They could be without commercial power for months while crews work to restore stable power to the island. The generators allowed many facilities to re-start production, but certainly not all. Moreover, most of the facilities that we know of, that have resumed production, maintain only partial operations. New shortages could result from these disruptions and shortages that existed before the storms could potentially be extended. 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.
We’re keeping a close watch on the most critical medical products. These are the products for which a shortage could have substantial impact on the public health. This list currently comprises about 40 pharmaceutical and biological drug products. 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.
I’ve been asked over the last couple weeks if I can provide more details on the specific products impacted. We’ll continue to provide as much information as we can appropriately make public and we’ll update regularly on our progress. We expect that, as we learn more about the supply chain and take additional steps to help restore production, FDA will pare its list of about 40 products to a smaller number that we’re monitoring. We’ll be proactive in communicating about products that reach a shortage situation.
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.”
(Source: U.S. Food and Drug Administration)