Publicly traded life science companies must navigate two overlapping regulatory agencies with distinct disclosure policies. The Food & Drug Administration (FDA) has a policy of under-disclosure to incentivize drug development while the Securities and Exchange Commission (SEC) encourages over-disclosure to avoid securities fraud. The FDA’s far-reaching and complex regulations, coupled with its acquiescence to confidentiality, obfuscates a life science company’s obligations under SEC regulation; as a result, life science companies are an attractive target for securities litigation. This Note explores the interplay between FDA and SEC regulations to pinpoint the source of the disproportionately high rate of securities litigation. It identifies two possible causes, one calling for drastic reforms and the other requiring a modest solution in comparison. It subsequently recommends the FDA release broad guidance on good disclosure practices in an attempt to reduce litigation for life science companies before more radical reforms are required.
Eric Schmid, Fraud or Confusion: A Pill for Chronic Securities Litigation in the Life Sciences Sector, 61 B.C. L. Rev. 1899 (2020), https://lawdigitalcommons.bc.edu/bclr/vol61/iss5/7