The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of active pharmaceutical ingredients (APIs) as well as prescription drug manufacturers to submit risk management plans (RMPs) to avert drug shortages.
This requirement could impose the very drug shortages it is designed to prevent, instead of just targeting those products at risk of drug shortage, pharmaceutical stakeholders told the agency.
The comments were submitted in response to FDA’s call for feedback on its draft guidance outlining which types of drugs and medical devices are susceptible to shortages and should be subject to a risk management plan (RMP). (RELATED: FDA asks manufacturers to develop risk management plans to avert shortages, Regulatory Focus 20 May 2022)
Others said the guidance should be more aligned with the International Council for Harmonisation’s (ICH) Q9 guideline on quality risk management…
