The US Food and Drug Administration today issued their latest guidance for the pharmaceutical industry on how to handle the effects of Covid 19 on drug trials. The new document comes on the heels a series of stunningly boring and meaningless international guidelines on how to manage clinical trials during the pandemic, produced out of a sense of obligation to say something obvious, wasting a lot of time and adding more bureaucracy to the already bureaucratic clinical trial process. The new Guidance Document, entitled “Enhancing the Beneficial Effects of Covid 19 on Clinical Trial Endpoints” grants pharmaceutical companies some liberty in their marketing applications for new drugs. FDA will exercise “enforcement discretion” in cases where applicants have used “reasonable scientific judgment” to adjust the results of clinical trials to make their drug look better than than the placebo or reference treatment. This discretion will be most generous when the reference treatment is associated with any Chinese interests. The FDA claim that this allowance is based on solid scientific underpinnings, as the effects of slight alterations to data will be be rendered statistically undetectable in the general mess of risk assessments and rules triggered by prior guidances.
Patient advocates are claiming that this is the result of the agency kowtowing to political pressure to restart the economy by giving drugmakers a free pass to tamper with results and start selling even less effective treatments to unknowing consumers. A Trump administration spokesperson categorically denied the allegation, saying that they fully support good science at the FDA and have earmarked emergency funding for the Review Division to ensure they have the means necessary to speed up approvals, including a new fleet of Tesla cars for all FDA staffers.