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From Health Law Daily, October 25, 2017

Gottlieb testifies on FDA preparedness, response to the 2017 hurricane season

By Harold Bishop, J.D.

In a House subcommittee hearing on the FDA’s response to the hurricanes that have devastated parts of our country, FDA Commissioner Scott Gottlieb, M.D. testified that the agency has played an integral role in the hurricane response efforts with a multifaceted approach, including providing on the ground support and making recommendations regarding food and medical products that may have been affected by the storms.

Gottlieb stressed that the devastation in Puerto Rico is the biggest challenge facing the FDA because the island is home to a substantial base of medical product manufacturing, with at least 33 percent of its gross domestic product in the pharmaceutical sector, representing about 8 percent of the medicines consumed by Americans. According to Gottlieb, there are about 50 firms in Puerto Rico that manufacture drug products (including blood fraction products, cardiovascular drugs, and cancer and HIV treatments), and about 40 medical device manufacturing facilities on the island (including manufacturers of pacemakers and blood collection devices).

The most significant role the FDA plays, according to Gottlieb, is after the storms, when facilities come back online and may need remediation and inspection, and when farmers seek to put crops and farmland back into commercial use. In Houston, for example, the FDA has been working with local producers to determine which crops can be used commercially and which must be diverted into animal feed.

In Puerto Rico, according to Gottlieb, the FDA is closely monitoring a list of about 30 products that are critical and either manufactured solely or primarily on the island. Of those 30 products, 14 are sole-source products, meaning there are no alternative drug products available. The FDA plans to address any shortages by facilitating safe foreign imports. The agency is also working to get needed food and medical products on the island, help hospitals get back to full operation, and in partnership with the AABB Inter-organizational Task Force (ITF), to facilitate access to safe blood products for the people of Puerto Rico.

Gottlieb provided the oversight committee with specific details related to medical product facilities, drug shortages, blood supply, agriculture and food supply, and deployment of FDA personnel in the impacted areas. The highlights of these details include the following:

  • Medical products. Manufacturing of medical products in Puerto Rico is running at minimum levels, with reports of below 50 percent common, many operating around 20 percent, and no firm operating above 70 percent of their normal operation. The major challenges include shortages of fuel for generators and of secondary supplies used in the manufacturing processes, such as medical gas.
  • Drugs. The FDA will address drug shortages through the careful selective importation of alternative supplies from approved manufacturing sites and reliable markets. One example involved the importation of an IV solution product and metronidazole manufactured by Baxter from multiple sites around the world.
  • Blood supply. Due to the FDA’s work with the AABB ITF and continued blood donations, blood banks have successfully met the needs across all impacted regions to date.
  • Agriculture and food supply. The FDA has been disseminating information to farmers and food producers about the proper handling of crops that have been exposed to floodwaters, and when these products can be safely diverted into animal feed uses. The agency has also had direct discussions with farmers and state officials to provide the most recent, science-based information on which crops can enter commerce without creating risks to consumers or animals.
  • FDA personnel. The FDA staff is fully accounted for across all areas of impact from hurricanes Harvey, Irma, and Maria. Gottlieb visited personally with the 100-member FDA team in San Juan, who worked hard to prepare and secure their facilities before the storms. Over 400 FDA staff deployed or are ready to deploy as part of the U.S. Public Health Service Commissioned Corps. In addition, more than 150 FDA civilian staff responded to the Federal Emergency Management Agency’s (FEMA) request for volunteers.

Hurricane storm relief has been the FDA’s highest priority since they struck, according to Gottlieb. He stressed that he has been personally engaged, on a daily basis in these relief efforts. He concluded that "the devastation in Puerto Rico – owing to its unique role as a base for the manufacture of many sophisticated, complex, and vital medical products – presents [the] FDA with especially complex challenges. We are committed to the people of Puerto Rico, their recovery, and their efforts to maintain their jobs and their proud and vital manufacturing history."

Companies: Baxter; Federal Emergency Management Agency; AABB Inter-organizational Task Force; U.S. Food and Drug Administration; U.S. Public Health Service Commissioned Corps

MainStory: TopStory DrugNews MDNews FoodNews AdulterationNews InspectionNews FoodSafetyNews GMPNews ImportNews SafetyNews

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