ECHA and FDA Waive Rules in Virus Crisis

The coronavirus epidemic is interrupting regulatory activity in both chemicals and pharmaceuticals. In two examples, one from Europe, the other from the US, the European Chemicals Agency (ECHA) and the Food and Drug Administration (FDA) have announced they will waive certain regulatory requirements and suspend penalties for non-compliance in some cases.

In a Mar. 23 statement, ECHA’s executive director, Bjorn Hansen, said that during the crisis the agency will ease some of the burden on chemical producers to meet deadlines for compliance with REACH.

ECHA said compliance deadlines for certain processes will be handled flexibly during the pandemic, as well as payment of invoices. For the duration, it said duty holders will also be informed directly through the agency’s IT systems.

For certain REACH deadlines that fall between March and May 2020, the regulatory authority is offering a two-month compliance extension.  This is to take hold where chemical producers have not been able to complete the registration process and were granted a final deadline during this period as well as for requests for further information related to confidentiality claims.

Also part of the ECHA plan is a 30-day extension of the deadline for companies to comment on draft decisions in which a registration has been judged as non-compliant with legal requirements.

Outside the regulatory sphere, the chemicals agency said it is cooperating with the European Commission to help member states source supplies of disinfectant chemicals such as isopropanol, 1-propanol and ethanol, which are running low.

FDA to ease risk evaluation rules

On Mar 22, the FDA communicated its temporary requirements for certain risk evaluation and mitigation strategies (REMS) that it said will be in force for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on Jan. 31.

The temporary guidelines will allow healthcare providers to continue clinical studies under less stringent circumstances if they believe the risks are manageable.

Concretely, the US health agency said that for drugs subject to REMS with laboratory testing or imaging requirements, doctors prescribing and/or dispensing them should consider whether there are compelling reasons not to complete these tests or studies and use their best medical judgment in weighing the benefits and risks while communicating with patients regarding these judgments.

Also for the duration, the FDA said it does not intend to take action against trials sponsors and others for failing to adhere to REMS requirements for certain laboratory testing or imaging studies. However, it may require REMS for certain drugs if it determines it is necessary to ensure that the benefits of the drug outweigh its risks.

Explaining the reasons for easing regulations temporarily, the FDA’s principal deputy commissioner Amy Abernethy said the agency recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine.