Statement by FDA Commissioner Scott Gottlieb, MD, on medical device manufacturing recovery in Puerto Rico

10/23/2017

During the weeks since Hurricanes Irma and Maria devastated the infrastructure of Puerto Rico, the U.S. Food and Drug Administration has joined federal and local agencies in the effort to help the people of Puerto Rico recover and begin to rebuild the island. Among the challenges the FDA has addressed is the potential for shortages of critical medical products. The FDA has been monitoring more than 40 drug products and working closely with dozens of pharmaceutical and medical device companies to help these important facilities get back online; enabling employees to return to work and manufacturers to ramp up production of medical products used by all Americans.

I’ve spoken recently about the importance of the medical product manufacturing presence in Puerto Rico, both to the economic well-being of the island, and to the health of all Americans. The FDA has provided information on the scope of drug manufacturing in Puerto Rico and our concerns around the potential for critical drug shortages resulting from impacts to these facilities.

Unfortunately, the devastation caused by the hurricanes to Puerto Rico’s medical product manufacturing sector goes beyond the effects on pharmaceutical companies. The FDA has been working equally hard to minimize shortages of medical devices manufactured in facilities on the island.

There are currently more than 50 medical device manufacturing plants in Puerto Rico, employing about 18,000 people. Collectively, they manufacture more than 1,000 different kinds of medical devices. These include simple but essential products like surgical instruments and dental products as well as highly complex devices such as cardiac pacemakers and insulin pumps.

To date, we’re monitoring about 50 types of medical devices manufactured in Puerto Rico that are critically important to patient care — because they may be life-sustaining or life-supporting and/or because there may be the single manufacturer of that device type. The FDA is working closely with about 10 manufacturers – some of which are the sole manufacturer of a certain device type – to prevent medical device product shortages across the U.S. We are particularly focused on blood-related medical devices.

Puerto Rico’s device industry is facing the same basic – but significant – challenges as most manufacturing sectors in Puerto Rico: a lack of power; connectivity; transportation; and clean water. Most, if not all, of these medical device manufacturers continue to run on generator power, and as a result, have been unable to return to pre-hurricane production levels.

In addition to these concerns, the medical device industry faces obstacles specific to the unique production requirements of each of these products. The device manufacturers have significant variation in the raw materials they require and the production processes they employ. These manufacturers face challenges in securing the various components critical to device development. These issues are exacerbated by the dependence on local subcontractors who provide much of the supplies needed for these unique manufacturing processes, but are facing their own challenges and shortages. This includes suppliers of components of a finished medical device or industrial gases, as well as tools that are critical to the production of devices.

The FDA is working with device companies and their suppliers to restore production in Puerto Rico as quickly as possible. Similar to our efforts with drug manufacturers, we are also working — in conjunction with manufacturers and government partners — to help device facilities secure fuel and the logistical support to move critical products onto and off the island. Manufacturing on the island remains fragile and the potential for device shortages persists.

As we continue to monitor at-risk products, the FDA is taking other steps to mitigate the potential for shortages. This includes considering, when necessary, importing a device from outside of the U.S., or allowing manufacturers to shift production to alternative sites.

We know it will likely be months before power is fully restored and medical product manufacturing returns to pre-hurricane levels. The FDA is committed to helping restore the medical product manufacturing in Puerto Rico as part of our efforts to protect the health of Americans and help the people of Puerto Rico recover their local economies and livelihoods.

The FDA continues to stand with the people recovering from this devastating series of storms. The FDA’s Chief Operating Officer and Associate Commissioner for Regulatory Affairs just returned from Puerto Rico, and I hope to return to the island again soon. At the FDA, we will continue to do all we can to aid in Puerto Rico’s full recovery.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.