New FDA Guidance Will Impact Supply Shortages

As hospitals continue to battle and get the COVID-19 pandemic under control, drug shortages have been a consistent problem.  The FDA has seen an increase in the number of drugs that are failing to meet the demand to treat these patients.  FDA-approved products are being used to treat both intubated and non-intubated patients.  Hospitals have been struggling to get these medications, and the need for these FDA-approved products is now becoming more urgent.  The FDA normally mitigates drug shortage issues by looking into the global pharmaceutical supply chain.  Pharmaceutical manufacturers are stepping up by reviewing their own supply chains, evaluating how they can increase capacity or otherwise help fill gaps in the market, all while working on potential vaccines and treatments for COVID-19.

However, due to the severity and unknown stress that the pandemic will cause on the pharmaceutical supply chain, the FDA is finding other ways to solve these drug shortages.  The FDA has decided to release temporary guidelines for both FDA registered outsourcing facilities and compounding pharmacies.  The FDA hopes that increased flexibility on the rulings to produce these FDA-approved products will help to alleviate supply issues.  This relaxation will allow for outsourcing facilities and compounding pharmacies to produce drug products for the hospitals in dire need of drug products to treat COVID-19 patients.

FDA guidelines have been released for FDA-registered outsourcing facilities and compounding pharmacies.  The FDA is relaxing the rules, and both parties can essentially compound exact or nearly exact copies of FDA-approved drug products used to treat COVID-19 patients. The copy can only contain one of the active ingredients and must be from the list of drug products currently in shortage used to treat COVID-19 patients. There are 15 drug products currently listed in shortage, as shown below.

The FDA requires that the hospitals have documentation proving that the drug products have been difficult to obtain and that the hospital is using the drug products to directly treat COVID-19 patients. For compounding pharmacies, a patient-specific prescription from the hospital is not needed, and hospitals must simply confirm and provide information that the medication will be used to treat a COVID-19 hospitalized patient. The FDA would like the compounding pharmacy to retrieve de-identified information from the hospital regarding which patients received the compounded drug products.  This could aid in tracking adverse events needing to be investigated. The FDA also provided guidance on expiration dates and stability testing for these drug products and has streamlined the process for outsourcing facilities.  Although the beyond-use-dating and expiration dating guidance will reduce some barriers and help compounding pharmacies to supply drug products that hospitals need, stability programs and testing must still be in place to protect patients.

For outsourcing facilities and compounding pharmacies, this is an opportunity to help with the current COVID-19 drug shortage problems. The reduced regulations will allow additional stakeholders in the pharmaceutical drug chain to produce these products. These rules can be retracted by the FDA at any point in time and are not permanent, so for manufacturers that originally produced these drug products, it will be important to update the FDA on when supply can meet the demand. The original manufacturers will want to have their drug products taken off the list as soon as possible. For other manufacturers struggling to meet supply for drug products for COVID-19 patients, these guidelines show that the FDA is willing to allow other sources to produce the drug products. Currently, there is a list of outsourcing facilities that are producing some of these drug products in shortage.

For the time being, the pharmaceutical drug supply chain will be strained during COVID-19. The relaxation of rules and regulations on the sourcing of drug products for hospitals will allow for drug shortages to be mitigated. However, the rules will put pressure on the original manufacturers to regain control of their product supply and meet the demand. Based on the current drug shortages and importation challenges, expect to see more manufacturers focus on their US operations in the coming years.  Manufacturers may begin seeking alternative active pharmaceutical ingredient (API) sources or moving finished pharmaceutical manufacturing to the US.  As the COVID-19 pandemic begins to slow down, how will the drug supply chain change in the near future, and will it need to be prepared for a potential second wave?

Posted June 16, 2020

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