To ease the dire shortage of two critically needed drugs, the US Food and Drug Administration has approved new suppliers overseas. The unavailability of cancer drugs Doxil and methotrexate have threatened the lives and care of thousands.
Temporary importation of unapproved foreign drugs is ‘considered in rare cases’ when there’s a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs, according to the agency.
- For Doxil, to treat ovarian cancer and tumors: the FDA will allow temporary shipments of a replacement drug, Lipodox, from India. The drug is made by Sun Pharma Global and distributed by Caraco Pharmaceutical Laboratories.
- For preservative-free methotrexate, to treat leukemia: pharmaceutical company Hospira has rushed 31,000 vials (which should last the nation a month) of preservative-free methotrexate from its plant in Australia to the US.
- The agency has also expedited the approval of a new manufacturer: a preservative-free methotrexate generic drug, manufactured by APP Pharmaceuticals, should be available in March and will continue indefinitely. (The approval of APP’s application, which has languished since 2010, became an FDA priority.)
Shortages developed when the largest manufacturer of methotrexate, Ben Venue Laboratories, voluntarily closed its manufacturing facility in Ohio because it couldn’t guarantee product safety. That turned the Boston Globe reportson-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.
That’s when the FDA reaches out to other firms to help meet the shortfall.
There is a years-long backlog of applications for new generic drugs at the FDA because the government does not have the money to hire enough reviewers to analyze the applications or inspectors to visit the facilities, many of them abroad. The generic drug industry tired of waiting for Congress to fully finance the FDA’s generic drug office and this year proposed providing the agency with $299 million in annual fees to finance the review process.
Shortages of cancer drugs have created an opening for dangerous unapproved versions to be sold to clinics and other healthcare providers, Bloomberg explains.
Luckily, the FDA increasingly has been able to prevent shortages, mainly due to an increase in manufacturers voluntarily notifying the agency when they anticipate shortages, Boston Globe reports.
In 2011, a total of 195 drug shortages were prevented, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.