As the calendar year is drawing to a close, I am writing my newsletter this month as a call to action from our FACT Community! Specifically, FACT and the member organizations of its Professional Relations Committee is seeking collaboration on comment submissions to the Food and Drug Administration (FDA) regarding its proposed rule for phasing out enforcement discretion for laboratory-developed tests. The FDA is proposing a policy under which it intends to require laboratory-developed tests to fall under the same enforcement approach as other in vitro diagnostic products, which includes regulatory approval and oversight.
FACT and FACT-accredited programs are concerned that FDA regulation of many lab-developed tests will have a tremendous and negative impact on access to care for patients (especially children and other patients with rare diseases) and will negatively impact new test development which will impact transplant and cell therapy programs. For example, lab-developed tests such as BMT chimerism tests, genetic sequencing tests, and flow cytometric tests will all be negatively impacted.
We will be providing more information in the coming weeks regarding comment submission, but the following are immediate steps that can be taken. In addition, information is provided in this newsletter which is dedicated to this issue.
- Submit a request to the FDA that the public comment period be extended to 120 days to allow adequate time to formulate responses that will fully inform the FDA of the impacts of this proposed rule.
- Review the rule and submit any initial questions you have regarding its impact to your patients to Kara Wacker at firstname.lastname@example.org.
Thank you in advance for your collaboration.
Catherine M. Bollard, MD