In an unprecedented and strategic move, the U.S. Food and Drug Administration (FDA) has granted permission for the temporary import of an unapproved Chinese cancer drug.
The decision comes amid a growing shortage of vital cancer drugs in the US, notably cisplatin, a widely used chemotherapy medication. The crisis has prompted the FDA to consider unconventional approaches, and this move stands as a testament to that flexibility.
Cisplatin: A Cornerstone of Cancer Treatment
Cisplatin, the drug in question, is a chemotherapy drug used extensively for treating various types of cancers, including testicular, lung, bladder, cervical, and ovarian cancers. According to the National Cancer Institute, up to 20% of cancer patients undergo treatment with cisplatin and other platinum-based chemotherapy drugs. The World Health Organisation also recognises cisplatin as essential to basic healthcare, further underscoring its critical role.
Roots of the Crisis
Alarmingly, the supply of this indispensable drug has plummeted since February, causing widespread concern within the medical community. The precipitating factor? A strategic decision by a primary provider of cisplatin to the US market, Intas Pharmaceuticals, to temporarily halt production. The India-based company’s move was sparked by an FDA inspection that discovered a significant failure in its quality control unit. Despite the company’s reassurances of working with the FDA to restart production, a definitive timeline remains elusive.
Widespread Consequences
This severe shortage of cisplatin has compelled hospitals across the US to make tough decisions. Hence, to make the most of their limited supply, healthcare providers have had to ration medications, and decrease dosages. Additionally, they had to prioritise patients who stand a better chance of a cure. More worryingly, doctors caution that some cancer patients’ lives could be in danger if the shortage persists. Moreover, the FDA has revealed that the crisis extends beyond cisplatin, with at least 13 other cancer drugs also in short supply across the nation.
An Unexpected Lifeline
Therefore, faced with this escalating crisis, the FDA has taken a bold step. The administration has given a green light to Qilu Pharmaceutical, a leading Chinese drug manufacturer, to temporarily export its version of cisplatin to the US. Although the FDA hasn’t approved Qilu’s version for the US market, the administration’s move attests to the desperate need for solutions. The China-based company is one of the top ten drug manufacturers in China. They are joining forces with Apotex, a Toronto-based company, to distribute 50-milligram vials of cisplatin in the US.
Prioritising Safety
Despite the pressing need for solutions, the FDA is committed to ensuring patient safety. The agency has asserted that it carries out stringent assessments of the quality of unapproved drug imports to ensure they meet safety standards for American patients.
A Cautionary Tale and a Lesson in Unity
The current situation serves as a stark reminder of the fragility of the global healthcare system. Yet, it also offers an optimistic glimpse into the potential for international cooperation in ensuring the health and wellbeing of patients globally. The FDA’s decision serves as a compelling example of how we can combat shared threats with shared solutions. This story is one the global healthcare community will undoubtedly be watching closely, as it continues to navigate the changing landscape of healthcare delivery.
