Report: FDA Considers Importing Unapproved Cancer Drugs

Facts

  • US Food and Drug Administration (FDA) is reportedly considering importing chemotherapy drugs from unapproved foreign manufacturers temporarily to help ease the nationwide shortage of at least 14 cancer drugs.1
  • This comes as some hospitals and clinics are completely out of oncology medications, while in others doctors are being forced to either ration cancer drugs or decide which patients will receive them first.2
  • The American Society of Clinical Oncology anticipates that lifting import restrictions would help to reduce the shortages, which are expected to continue through June. Similar actions have been taken in the past on other issues — including last summer amid a serious shortage of baby formula in the US.1
  • Among the drugs in short supply is carboplatin, a chemotherapy agent used as first-line treatment for several cancers, whose shortage is related to quality concerns at one manufacturing facility in India and the chronic low profitability problem of this industry.3
  • National delivery of the platinum-based drug last week had raised hopes of a solution to the crisis. However, it remains unclear whether the end of the shortage is nearing or whether the supply will continue to rise and fall.4
  • Drug shortages are at record highs, according to a March report from the Senate Committee on Homeland Security and Government Affairs. By the end of 2022, there were 295 active drug shortages — a five-year high.3

Sources: 1CNBC, 2ABC News, 3NBC, and 4USA Today.

Narratives

  • Left narrative, as provided by New York Times. A cutthroat generic drug industry has exacerbated the worst aspects of the free market. Manufacturers have offshored their factories to reduce FDA inspections and have been caught falsifying clinical trials and with substandard quality control. Most drugs in the US are sourced from outside of the country in the pursuit of profit. A national rating system for companies and factories would force drug companies to clean up their act.
  • Right narrative, as provided by Wall Street Journal. Government interference in the market has made it unprofitable to produce lifesaving medicine, as efforts to lower drug prices make drug manufacturing increasingly more expensive and the supply chain more fragile. Pharma troupes are forced to outsource and cut corners to stay solvent — just as the government bears down on them to reduce healthcare spending. Tax cuts and other incentives would help shore up our drug supply.

Predictions