FDA plea for notice on drug shortages
pharmafile | June 14, 2011 | News story | Manufacturing and Production |Â Â FDA, pharma manufacturingÂ
The FDA has asked US drugmakers to give advance warning of production problems which could lead to shortages in available medicines.
A report on the FDA website indicates that medicine shortages – and particularly those involving medically-essential drugs – are “continuing to increase at a rapid pace after reaching a record high in 2010”.
The agency said the number of drug shortages has nearly tripled over the last six years from 61 drug products in 2005 to 178 in 2010, not including vaccines, immune globulins and other biologic or blood-derived products.
“In 2011 FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs”, it added. At the moment the current list of shortages – which can be viewed on the FDA website here – includes over 70 drugs.
Critical areas where shortages are common include cancer drugs, anaesthetics, so-called, ‘crash cart’ drugs used in emergencies and electrolytes for patients being fed intravenously, amongst others. Many of the shortages have been caused by quality and manufacturing problems, according to the FDA’s listing, although other factors such as higher than expected demand, recalls and a shortage of active pharmaceutical ingredients (APIs) are also cited.
Ilisa Bernstein, deputy director of compliance in the FDA’s Center for Drug Evaluation and Research, notes that there is currently no legal requirement for companies to tell the FDA if one of their medicines could become scarce. And while they must inform the agency six months in advance if they plan to discontinue making a product, there is no legal penalty if they decide not to.
In February, a bill aimed at changing that situation was introduced in the Senate by Senators Amy Klobuchar and Bob Casey. This would make it mandatory for pharmaceutical companies to notify the FDA whenever a factor arises that may result in a drug shortage. Meanwhile the agency would be obliged to provide up-to-date, public notification of any shortage situation and the actions it will take to address them.
In the meantime, “FDA is urging drug makers to voluntarily notify us if they change production quantities of drugs as a matter of corporate responsibility and in the interest of public health,” according to Bernstein.
That helps the FDA approach other firms to see if they can boost production, or arrange for imports from overseas. Last year the agency was able to prevent 38 drug shortages because it was granted prior notice, it said.
Phil Taylor
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
