FDA Commissioner Addresses Potential Drug Shortages from Mfg in Puerto Rico
The US Food and Drug Administration’s (FDA’s) Commissioner Scott Gottlieb, MD, provided an update of the FDA’s efforts to track the impact of Puerto Rico’s medical-product manufacturing base following destruction from Hurricanes Irma and Maria.
Gottlieb gave an update on how the drug-manufacturing base is faring. “Some of these facilities were hit harder than others,” Gottlieb said in an agency statement. “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 storms most concerned about, FDA leadership is in contact with senior management teams.”
Drug manufacturing is an important part of Puerto Rico’s economy and provides an export base to the mainland in the US. The pharmaceutical and biological drug products and medical devices produced on Puerto Rico account for approximately 30% of Puerto Rico’s gross domestic product, according to information from the FDA. Approximately 80% of the drug products manufactured in Puerto Rico are consumed by US citizens in Puerto Rico and across all 50 states, according to the FDA.
Gottlieb said the FDA is keeping track of products for which a shortage could have a “substantial impact” on the public health. The list currently comprises about 40 pharmaceutical and biological drug products. The FDA expects that, as it learns more about the supply chain and takes additional steps to help restore production, the agency will pare its list of about 40 products to a smaller number.
Gottlieb said the agency has been in daily communication with some companies. “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 [and] get clearance to move logistical support into the island or finished goods to their recipients,” Gottlieb said.