https://www.cidrap.umn.edu/news-per...arma-firms-warn-demand-spikes-ahead-shortages
FDA leader wants pharma firms to warn of demand spikes ahead of shortages
Filed Under:
Drug Supply Chains
Dec 05, 2022
A US Food and Drug Administration (FDA) official wants pharmaceutical companies to start reporting spikes in demand for drugs in an effort to prevent or ease shortages, Endpoints News reports.
In a webinar last week hosted by the nonprofit Alliance for a Stronger FDA, Valerie Jensen, RPh, associate director of the FDA's Drug Shortage Staff, noted increasing quality-related issues and demand for certain drugs over the past decade—but particularly amid the COVID-19 pandemic. She called on drug companies to report demand spikes, although they are currently required only to report supply disruptions.
"I think that really the key is early notification," Jensen said. "The earlier companies let us know about an issue, the earlier we can deal with it."
Drug shortages are complex and multifaceted, but one issue, she said, is that some manufacturers have had to produce COVID-19 vaccines and products in addition to or instead of their usual products. "So, the same products are being made on those lines that are making the vaccines and Covid-related products, and then that creates a competition situation, Jensen said.
Recent surges of respiratory illnesses such as flu and respiratory syncytial virus (RSV), together with a steady flow of COVID-19 cases, have also contributed to shortages and have complicated patient care.
Examples of ongoing major drug shortages are Adderall and amoxicillin. Items used to make, store, and deliver drugs (eg, glass, filters, vial-filling equipment) are also hard to source, Jensen said.
To learn whether the United States can import certain drugs from other countries, Jensen said she has stepped up coordination with international regulatory agencies. She is also working with experts to inform the public and speed the review of products that manufacturers need to increase drug supplies and with pharmacy associations and other trade groups to identify and address pharmacy-level issues.
FDA leader wants pharma firms to warn of demand spikes ahead of shortages
Filed Under:
Drug Supply Chains
Dec 05, 2022
A US Food and Drug Administration (FDA) official wants pharmaceutical companies to start reporting spikes in demand for drugs in an effort to prevent or ease shortages, Endpoints News reports.
In a webinar last week hosted by the nonprofit Alliance for a Stronger FDA, Valerie Jensen, RPh, associate director of the FDA's Drug Shortage Staff, noted increasing quality-related issues and demand for certain drugs over the past decade—but particularly amid the COVID-19 pandemic. She called on drug companies to report demand spikes, although they are currently required only to report supply disruptions.
"I think that really the key is early notification," Jensen said. "The earlier companies let us know about an issue, the earlier we can deal with it."
Drug shortages are complex and multifaceted, but one issue, she said, is that some manufacturers have had to produce COVID-19 vaccines and products in addition to or instead of their usual products. "So, the same products are being made on those lines that are making the vaccines and Covid-related products, and then that creates a competition situation, Jensen said.
Recent surges of respiratory illnesses such as flu and respiratory syncytial virus (RSV), together with a steady flow of COVID-19 cases, have also contributed to shortages and have complicated patient care.
Examples of ongoing major drug shortages are Adderall and amoxicillin. Items used to make, store, and deliver drugs (eg, glass, filters, vial-filling equipment) are also hard to source, Jensen said.
To learn whether the United States can import certain drugs from other countries, Jensen said she has stepped up coordination with international regulatory agencies. She is also working with experts to inform the public and speed the review of products that manufacturers need to increase drug supplies and with pharmacy associations and other trade groups to identify and address pharmacy-level issues.