Vincristine Shortage and the FDA

An incredibly important drug to treat a lot of childhood cancers, vincristine, is facing massive shortages in the United States. Vincristine is used as the backbone of many treatments for childhood cancer for leukemias, lymphomas, and brain tumors. This is particularly problematic as there is no appropriate substitute.

There used to be two main suppliers for vincristine: Teva Pharmaceutical Industries and Pfizer. Unfortunately, in July, Teva stopped manufacturing vincristine for “business decisions”. Pfizer is now the sole manufacturer of vincristine and has had some manufacturing problems which has only exasperated the vincristine shortage. Oftentimes, these shortages happen to older, generic drugs which are difficult to manufacture, but have a low price. This causes manufactures to lose money and not manufacture the drug anymore.

The Children’s Oncology Group (COG), who specializes in pediatric cancer clinical trials in the U.S., issued a statement on October 16^th saying that any “situation that requires rationing of drug is unacceptable,” but it “welcome[s] the news that drug distribution should resume soon.” Peter C. Adamson, the Chair of the COG proposed an action plan to ensure that this kind of drug shortage would not happen again. His plan includes the establishment and maintenance of a national stockpile of key cancer drugs used in childhood cancer treatment, and the U.S. government purchasing contracts that provide a guaranteed buyer and help stabilize the volatile drug market.

A drug shortages task force was established in 2018 by former F.D.A. Commissioner Scott Gottlieb and they plan on submitting a report with findings and recommendations to Congress by the end of the year.

However, there are some who question the responsibility of the government in dictating which drugs manufacturers should produce. Sharona Hoffman, professor of law and bioethics at Case Western Reserve University School of Law, says “you can’t force a manufacturer to produce a particular drug against its other drugs, so this is a big problem.” In a free market, the government does not have the jurisdiction to tell manufacturers which drugs they should or should not produce.

Drug shortages are not a new issue in the U.S., however the vincristine shortage has brought more light to this incredibly important issue. The F.D.A. has a lot of room to improve in ensuring that the drugs needed to save lives are readily available.

https://www.nytimes.com/2019/10/14/health/cancer-drug-shortage.html#

https://www.forbes.com/sites/victoriaforster/2019/10/16/fda-deliveries-of-scarce-childhood-cancer-drug-due-to-resume-but-not-until-late-october/#1196439a56d9