FDA Proposes Higher Standards For Fast-Tracked Cancer Meds

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Facts

  • The US Food and Drug Administration (FDA) is considering policy changes that could require drug makers to conduct more stringent trials to win fast-track approvals of cancer drugs.1
  • The FDA’s proposed recommendation comes amid wide criticism of the agency's accelerated approval pathway and a federal investigation into its approval of Biogen Inc.'s Alzheimer's treatment Aduhelm.2
  • The FDA issued a draft guidance on Friday that acknowledged the program’s success in providing cancer patients with earlier access to novel treatments while discussing the design of clinical trials and ways to improve the data available at the time of accelerated approval.3
  • If implemented, the new policies would see treatments subjected to randomized controlled trials, where they would be measured against conventional treatments rather than the commonly-used "single-arm studies" that are absent of a comparison.1
  • The FDA's recommendations include two options: a randomized trial before and after an accelerated approval or only one randomized trial with long-term check-ups.2
  • The FDA is accepting feedback on the draft guidance until May 26.4

Sources: 1Axios, 2Reuters, 3Yahoo Finance, and 4Fierce Biotech.

Narratives

  • Establishment-critical narrative, as provided by The BMJ. The FDA has been engaged in blatant drug approval corruption for a long time, with one of the most recent examples being its “warp speed” approval of the COVID vaccines. This negligence runs deep, as the FDA has a history of not properly overseeing a wide range of clinical trials and not adequately publishing any errors. The FDA’s entire process endangers public health and is unacceptable.
  • Pro-establishment narrative, as provided by Google Books. Some critics say the FDA approves drugs too quickly, while others say the agency works too slowly. The truth is that the FDA independently analyzes each medication and its clinical trial while weighing the impact of a treatment reaching the market. For oncology drugs, speed to market is a life-or-death matter, and the FDA knows that. In other cases, the FDA can take its time conducting trials. Overall, the agency takes a pragmatic approach to its regulatory process.