An adult hold the hand of a child with an IV

Teva to Resume Production of Critical Pediatric Oncology Drug: Too Little, Too Late

By Beatrice Brown

In my last blog post, I reflected on the ethical issues relevant to a critical shortage of a widely used pediatric oncology drug, vincristine. The shortage occurred after one of two pharmaceutical companies producing the drug, Teva, withdrew from the market, and the other, Pfizer, was unable to keep up with the demand due to manufacturing delays. On November 13, Teva announced that they would resume production of vincristine. The announcement stressed that they have decided to re-introduce the product because of the anticipated lack of “reliable single supply in the near term.” They also seemed to shift the moral blame from their decision, stating that “When Teva removed vincristine from the market earlier in the year there was no indication at all of a possible shortage” and that they assumed that Pfizer, which supplied 97% of the market, could easily absorb the demand. Furthermore, Teva emphasized that before discontinuing a product, they “always evaluate the need” for it, noting the caveat that they usually do not know supply challenges that other manufactures may be facing. However, as noted by Forbes, there will be no “short-term impact on the ongoing shortage” as a result of Teva’s decision, as their new supply of vincristine will not be available until early in 2020.

I raised the question in my last blog post on the shortage of vincristine of whether pharmaceutical companies have a moral obligation to continue producing a critical drug, even if the decision is announced in advance. I argued that it would have been more ethically permissible for Teva to have reduced production over time, eventually halting production, in order to alleviate the issue of manufacturing delays that Pfizer subsequently faced. I would like to further explore this question in light of Teva’s recent decision to resume production.

Given Teva’s response, it seems to me that they may have felt that they had a moral obligation to resume production. However, their decision does not fully alleviate any blame that we may assign them as a result of failing to fulfill their moral obligation to continue production of this critical drug or pulling out of the market in a more ethically permissible manner. There is also the question of whether, as a result of failing to meet this moral obligation, they owe anything to these pediatric patients who missed doses of vincristine that they desperately need, particularly if their condition has worsened as a result. It is certainly praiseworthy, though, that they have decided to resume production and aid pediatric cancer patients.

However, I cannot help but wonder if the decision was made to save face: Forbes noted that there was a petition requesting that Teva resume production with over 200,000 signatures. And if the decision was truly made as a result of feeling a moral obligation, then why did it take over a month after the announcement of the shortage for them decide to re-enter the market? The time gap and petition seem to suggest that perhaps they felt pressured and shamed into this decision, coupled with the desire to combat bad press on the matter that may affect their future sales. Pharmaceutical companies, after all, are a business at the end of the day.

In addition, Teva’s decision seems like “too little, too late” for having an appreciable effect on the current shortage that we are facing. For one, Pfizer is expected to be able to resume shipments this month. Second, Teva’s production will not be available until early 2020, which is when Pfizer asserts that they will be able to return to normal production levels of vincristine by. Yet Teva’s announcement seems to suggest that they are re-entering the market with the hopes of alleviating the current shortage, going so far as to say that they are pursuing the production route that “provides the fastest route to market” and noting the lack of reliable single supply in the near term. Of course, having two producers on the market is better than only having one, as Dr. Unguru notes to Forbes, and hopefully Teva re-entering the market will prevent shortages in the long-run, but the short-term shortage is certainly not alleviated by their decision.

More must be done to prevent similar critical drug shortages in the future. Moral shame seems to have motivated Teva to re-enter the market for vincristine, but this shortage should not have happened in the first place, as they should have felt a moral obligation to the patients they serve. But if morality is not enough to ensure that these pharmaceutical companies continue to produce critical drugs, then what are we as a society to do? Policy is one path that we may take – Senators Susan Collins and Tina Smith introduced the Mitigating Emergency Drug Shortages (MEDS) Act late last month to “give the FDA increased authority and expand manufacturing reporting requirements.” It is perhaps the case that even legislation such as this is not enough, as it is unclear whether Pfizer could have anticipated the manufacturing delays that they experienced once Teva withdrew from the market (although, arguably, such delays are predictable given past experience that proves such an occurrence). But at the very least, such legislation is a step in the right direction. And one thing is for certain: these critical drug shortages are morally unacceptable.

Beatrice Brown

Beatrice (Bea) Brown is a Research Assistant for the Program On Regulation, Therapeutics, and Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. She received her Master of Bioethics (MBE) from Harvard Medical School in 2020 and her BA in Ethics, Politics, & Economics from Yale University in 2019. During the 2019-2020 academic year, Bea was a Petrie-Flom Student Fellow and wrote a research paper proposing a new argument for a constitutional right to physician-assisted death by redefining what it means to heal.

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