Monday, December 11, 2017

FDA worries lack of power in Puerto Rico could result in drug shortages

By on October 10, 2017

SAN JUAN – Food and Drug Administration (FDA) Commissioner Scott Gottlieb said he is in touch with Puerto Rico pharmaceutical firms as the island-wide power outage may cause shortages of some 40 life-saving drugs that are only manufactured in Puerto Rico.

However, La Fortaleza Public Affairs Secretary Ramón Rosario downplayed concerns of a shortage, emphasizing that the government has been supplying drug manufacturers with electric service. He said the government has not received any notifications regarding potential drug shortages.

About 80 percent of the drug products manufactured on the island are consumed by U.S. citizens in Puerto Rico and across all 50 states, Gottlieb said.

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, not including medical devices manufactured on the island as well. Puerto Rico is vital to the health and wellbeing of all Americans, he said in written remarks.

FDA: Drug shortages possible due to Puerto Rico power outage

“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,” he said.

Gottlieb said the list of pharmaceutical and biological products for which shortages could arise could have a substantial impact on public health. He did not name the drugs, but one them, for instance, is used to treat childhood leukemia and another is used to treat HIV.

In this April 5, 2017 photo, Food and Drug Administration (FDA) Commissioner-designate Dr. Scott Gottlieb testifies on Capitol Hill in Washington at his confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee. (AP Photo/J. Scott Applewhite)

“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,” he said.

However, he expects to be able to pare down the list of drugs to a smaller number. The FDA is currently working with at least five companies impacted by the hurricane to prevent “critical” shortages of medical products in Puerto Rico. The assistance includes coordinating transport of certain critical drugs out of the island. The number could increase in coming weeks, he said.

“We’ll be proactive in communicating about products that reach a shortage situation.
The FDA remains committed to Puerto Rico’s future,” he said.

The Pharmaceutical Industry Association did not immediately return calls for comment.

La Fortaleza Public Affairs and Public Policy Director Ramón Rosario (CB photo)

Rosario said pharmaceutical companies have requested help in efforts to regain electric service. He also noted that the FDA has not sent the government an official notification, expressing concern.

“They are critical structures in Puerto Rico,” he said, suggesting they are a priority in the list of structures to be powered.

“We are supplying them with energy and so far they have been operating…We worried about all sectors, including agriculture. Certainly, we have to work hard to restore service to these industries so they stay in Puerto Rico…We don’t have an official statement alerting us of a possible emergency in that regard,” Rosario said.

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