October 6, 2017

Puerto Rico's drugmakers are still struggling after Hurricane Maria—and shortages could result, FDA warns

Daily Briefing

    Federal officials and health care companies are concerned that the damage caused by Hurricane Maria in Puerto Rico could lead to drug and medical device shortages.

    When a disaster occurs, the whole hospital is our patient

    According to the Times, drugs and medical devices are Puerto Rico's leading export. Pharmaceutical and medical device companies employ nearly 100,000 individuals on the island, and critical treatments for cancer, diabetes, and heart disease are manufactured at 80 pharmaceutical factories. Top-selling medicines—such as the rheumatoid arthritis drug Humira and the blood thinner Xarelto—are manufactured on the island.

    Background on Puerto Rico and Hurricane Maria

    The U.S. territory is still recovering from Hurricane Maria, a powerful Category 4 storm that struck the island on Sept. 20 with 140 mph winds.

    Puerto Rico Gov. Ricardo Rosselló (D) on Tuesday said the official death count from Hurricane Maria had reached 34. Rosselló attributed three of the deaths to oxygen delivery failures due to power outages. He said other causes of death included heart attacks, drownings, and suicides.

    According to the Wall Street Journal, 51 of the territories 69 hospitals are open. But as of Wednesday, hospitals—as well as—most of the island's 3.4 million residents—were still without a stable power source, relying largely on generators. Officials say it could take four to six months to fully restore power to the island.

    Officials, industry express concern over drug shortages in the aftermath of Hurricane Maria

    The unstable power supply also presents a problem for drug manufacturers that rely on refrigerators to store their products, the Times reports. Wilberto Maldonado, a pharmaceutical consultant, said drug and device makers are facing difficulty in reaching employees, and some have turned to radio advertisements.

    FDA Commissioner Scott Gottlieb this week told members on the House Energy and Commerce Committee's Subcommittee on Health that some of the medicines produced on the island "are critical to Americans" and that a "loss of access could have significant public health consequences."

    Specifically, he said FDA has "a list of about 40 drugs that [it is] very concerned about." Of the 40 drugs, Gottlieb said 13 are "sole-source," which means they are only produced by one company. Affected items include HIV treatments, injectable drugs, and certain medical devices. Gottlieb said the list "reflects [treatments from] maybe about 10 firms."

    One of the drugs Gottlieb expressed concerns over is methotrexate, which is made by Mylan. The drugmaker issued a broad statement, saying company is "working closely with FDA to help address drug shortage concerns."  Mylan said the company's plant has communication, water, and electricity sources, but it is "working on ways to make them sustainable for manufacturing purposes."

    Many device and drugmakers have said they do not expect a shortage of drugs or devices because their factories have been able to restore power with generators.

    Ernie Knewitz—a spokesperson for Johnson & Johnson, which manufacturers Tylenol and an HIV drug called Prezista in Puerto Rico—said the company has "a strong local team working through incredible logistical challenges, and [it is] seeing progress each day." Knewitz said the company is "closely monitoring [its] product inventory levels … to ensure all critical needs are met."

    Others are taking precautionary measures. For instance, Baxter, a medical-supply company, said it will limit the shipments of products manufactured in Puerto Rico, including small bags of dextrose and saline, to conserve supplies.

    What happens next

    Lobbyist and executives from health care companies on Tuesday met with HHS and FEMA to request assistance.

    AdvaMed, the trade group representing device makers, asked for priority access to the electricity grid when it is restored. Greg Crist, a spokesperson for AdvaMed, said, "Even if companies are fine now with diesel fuel, we want to make sure we're in the queue in terms of priority, because if there is an electricity shortage well into November, for example, how can we as an industry make sure we are in line for those priorities, once you've taken care of hospitals and essential needs?"

    Erin Fox, an expert on drug shortages at the University of Utah, said it is difficult to determine what drug shortages the U.S. could face, because drug manufacturers do not publicly disclose where they make their products. Fox said, "Because we have no transparency around that … it's actually hard to know the true impact of this" (Thomas/Kaplan, New York Times, 10/4; Hernandez, Wall Street Journal, 10/4; Silva/Gamboa, NBC News, 10/4).

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