Obama takes action to curb medicine shortages
pharmafile | November 1, 2011 | News story | Manufacturing and Production, Research and Development, Sales and Marketing |Â Â FDA, Obama, drugsÂ
US President Barack Obama has ordered the FDA and Department of Justice to take action to reduce and prevent medicine shortages, protect consumers and prevent price gouging.
Figures provided by the White House suggest that the number of reported drug shortages has tripled from 61 in 2005 to 178 in 2010, with around 80% of last year’s tally accounted for by sterile injectable drugs, including cancer treatments, antibiotics and nutrition products.
The main reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and shortages in active pharmaceutical ingredients (10%), according to the data, which comes from a recently-completed review by the Department of Health and Human Services.
One notable case recently reported involved an acute shortage of Johnson & Johnson’s breast cancer drug Doxil (doxycycline), caused by problems at contract manufacturing organisation Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim. Those quality issues proved so acute that they prompted Ben Venue to exit the CMO business altogether in the coming years and focus on selling generic medicines.
“While the FDA has successfully prevented 137 drug shortages since the beginning of 2010, drug shortages have been increasing in frequency and severity in recent years and adversely affecting patient care”, said the White House statement.
The Executive Order directs the FDA to broaden its reporting of potential prescription drug shortages and speed up review of new manufacturing sites, drug suppliers, and manufacturing changes. Early disclosure of a shortfall in manufacturing capacity, it noted, “can have a significant, positive impact on the incidence and duration of drug shortages”.
To help the FDA achieve that goal Obama is also planning to increase staffing resources, with the creation of a ‘surge team’ of six to eight FDA staffers to lead the drug shortage programme.
Other measures taken by Obama include a letter to drugmakers reminding them of their legal responsibility to notify the FDA of drug discontinuations and asking them to voluntary report shortages.
The President has also asked the DoJ to examine whether any secondary drug wholesalers or other market participants have responded to potential drug shortages by illegally hoarding medications or raising prices to gouge consumers.
“Many different factors contribute to drug shortages, and solving this critical public health problem will require a multifaceted approach”, said Obama.
Phil Taylor
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