Dive Brief:
- The Food and Drug Administration is still working to mitigate IV saline and amino acid drug shortages in the U.S. following the massive damage wrought on Puerto Rico by Hurricane Maria in September 2017. The situation has been exacerbated by a worse-than-usual flu season in the U.S.
- According to FDA Commissioner Scott Gottlieb, current shortages of IV fluids, which resulted from the loss of power to manufacturing sites across the island, should improve in "the coming weeks and months."
- In the meantime, to improve availability the FDA is working with manufacturers such as Baxter International and B Braun to import products from facilities outside the U.S., and approving IV saline products from additional companies.
Dive Insight:
Hurricane Maria, the most dramatic of the 2017 Atlantic hurricane season and potentially the worst natural disaster on record in Dominica and Puerto Rico hit in September 2017. The storm took out the island's power grid. Aside from the obvious impact on the island's occupants, further-reaching ramifications include the impact on pharma companies with manufacturing bases on the island, such as Amgen, Inc., Eli Lilly & Co., Johnson & Johnson, Baxter International, Inc., and AbbVie.
Around 8% of U.S. medicines are manufactured in Puerto Rico.
By October 2017, a number of the plants were beginning to return to operations, with companies operating at 70% of capacity at most, but with some at less than 20% of capacity. This still left hospitals across the U.S. at risk of shortages of IV solutions, with the American Hospital Association warning that only 10-15% of hospital and health system demand might be met. As an example, the FDA had to import alternative supplies of IV solution and metronidazole because of the disruption of Baxter's facility.
The situation is beginning to look rosier now, as all the companies that manufacture products that were on the FDA's initial list of drugs considered critical and at risk of potential shortages are now on the power grid, and their output is increasing.
The return of Baxter to the grid, and the return of ICU Medical to the market, is particularly significant for those patients needing IV amino acids.
The FDA is taking a number of steps to improve the current situation. It is approving IV saline products from Fresenius Kabi and Laboratorios Grifols, expected to be available in the "next several weeks," according to the agency.
The agency is also working with manufacturers to extend expiration dates where this can be done safely, allowing hospitals to use products in stock that are close to an expired date. And it is also monitoring the product supply and levels of empty IV bags, which are being used by hospitals and clinics to mitigate the supply situation.
The issues are not yet fully resolved in Puerto Rico – earlier this month Gottlieb described the production situation as "fragile" and the island will take many months or even years to return to normal. In the meantime, the FDA will continue to maintain its list of current and resolved drug shortages and discontinuations.