The Food and Drug Administration (FDA) yesterday said that a Gallium citrate GA 67 injection used to diagnose Hodgkin’s disease, lymphoma and bronchogenic carcinoma would soon face a supply shortage, so it is initiating a special import program for the radiopharmaceutical agent.
The FDA in April launched a drug supply report platform to ensure steady supply of essential drugs in response to possible shortages after the COVID-19 pandemic.
FDA Deputy Director Cheng Hwei-fang (陳惠芳) yesterday said that as of Tuesday last week it had handled 664 reports and is still dealing with four others.
Photo: CNA
Among them, 201 reports, or 30.3 percent, were found to have no shortage problem, 379 (57.1 percent) reports resulted in recommendations to use alternative drugs as a temporary substitute, 63 cases (9.5 percent) had a short period of shortage, but quickly resumed normal supply and 21 cases (3.1 percent) did not have alternatives and were subject to open solicitation, Cheng said.
The 21 investigations that showed there was no alternative drugs available included nine with active ingredients, she said.
Eight of the nine have been approved for special import programs and the other, the Gallium citrate injection, is also under an open solicitation process, she added.
There is only one company in Taiwan with a permit to manufacture Gallium citrate, but due to routine maintenance of its equipment, it would temporarily stop producing the drug from Feb. 7 to March 18, Cheng said, adding that as there are no alternative drugs, open solicitation was initiated last month.
FDA Medicinal Products Division senior specialist Yang Bo-wen (楊博文) said the half-life of gallium 67 is about 70 hours, so the drug cannot be mass produced and stored.
It is usually ordered by hospitals when there is clinical demand, Yang said, adding that about 40 vials are used per week.
A vial provides enough of the drug for multiple injections, and the dosage differs according to the patient and the test being done, so it is difficult to estimate how many people might be affected by the shortage, he said.
There is a company that has applied to import the drug and is in the contract signing process, which is expected to help ease the shortage by February, Cheng said.
Additional reporting by CNA
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