Sending Office: Honorable Brendan F. Boyle
Sent By:

        Request for Signature(s)

Modernize FDA Drug Development Regulations

Deadline: May 30th


**This language would request that the FDA Commissioner modernize 90 drug development regulations by replacing mandates for ‘animal’ data with ‘nonclinical’ data. ‘Nonclinical’ includes traditional animal testing and
modern human-based approaches. This language also requests the FDA create a pathway for evaluation and acceptance of in vitro and computational nonclinical approaches.**


Dear Colleague:

Please join me in urging the Food and Drug Administration (FDA) to modify its existing regulations and programs that guide pharmaceutical development to clearly allow for use of modern nonclinical testing approaches. Our lives depend on safe and effective
medicines. But, according to the National Institutes of Health (NIH), approximately 95% of new medicines fail in clinical trials because they are unsafe or do not work in humans, despite appearing safe and effective in nonclinical animal-based tests. This
must change.

Nonclinical tests occur prior to clinical trials in humans and intend to inform whether a potential medicine is expected to be safe and effective for humans. Many nonclinical tests are traditionally conducted using animals, including monkeys, mice, rats
and dogs, although animal tests often poorly predict human outcomes.

Modern, human-based nonclinical tests, such as tissue chips and sophisticated computer models, provide human-relevant information because they incorporate human cells, tissues and biological processes. They offer the possibility of more predictive data obtained
more quickly and at less cost, yet distinct barriers to their use remain.

Current FDA regulations mandate or prioritize animal testing over modern human-based nonclinical approaches that do not involve animal testing. These regulations must be modified to account for scientific advances and ensure the longevity of the regulations
in the face of rapidly advancing nonclinical approaches.

Additionally, a clear pathway for agency evaluation and acceptance of modern human-based approaches must be established. Qualification is an FDA process whereby new approaches may be evaluated and accepted by the agency, yet the existing agency qualification
program is not inclusive of human-based methods such as in vitro and computational approaches. In order to expand eligibility to human-based methods, FDA should establish a qualification program for
in vitro and computational methods.

For the reasons outlined above, we urge you to join us in signing the letter below in support of our request that the FDA modernize its regulations by replacing ‘animal’ references with ‘nonclinical’ and establish a clear pathway for acceptance of human-based
nonclinical approaches. The deadline to sign the letter is May 30th.

Thank you for your consideration. If you have any questions or choose to sign, please contact Ted Steinberg at


Brendan F. Boyle
Member of Congress


***Letter Text Below***


Dear Acting Commissioner Sharpless:

Over the past year, the FDA has prioritized the integration of predictive nonclinical tools for assessing drug safety and efficacy through initiatives such as the Predictive Toxicology Roadmap. We look forward to continued prioritization and implementation
under your leadership.

To help implement roadmap goals and ensure the most predictive tests are integrated into the drug development pipeline, we urge the agency to take the following complementary actions.

  • Modify the attached regulations that mandate or prioritize the use of animal tests over modern human-based nonclinical approaches. The references to ‘animal’ data in these regulations could be changed to ‘nonclinical,’ which encompasses
    in vivo (animal), in vitro (animal and human-based) and in silico (animal and human-based) approaches. This would neither indicate a ban on animal testing nor a mandate for human-based approaches. It would merely neutralize the regulations
    to reflect the agency’s discretion to accept any valid nonclinical method. These changes remove regulatory barriers and will help ensure the longevity of the regulations in the face of rapidly advancing nonclinical approaches.
  • Establish a qualification program for “in vitro and computational” methods. The roadmap describes
    in vitro platforms and sophisticated computer models as having the potential to improve drug development and suggests qualification may help with integration of such approaches. It remains unclear how the methods the roadmap seeks to integrate may
    be qualified, because qualification is limited to three existing programs. Launching an “in vitro
    and computational” qualification program would assist with roadmap implementation and extend qualification eligibility to these approaches. To address global harmonization of method acceptance, we ask the agency to work with the International Council for
    Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to harmonize acceptance of qualified approaches.

While nonclinical tests are crucial for understanding whether a potential medicine is likely to be safe and effective in humans, a large percentage of new medicines that appear safe in animals later fail in humans. Significant progress is being made with
advanced human-based in vitro and in silico approaches such as tissue chips and sophisticated computer models to better predict human outcomes. Indeed, the FDA has played an integral role in many of these successes, such as the National Institutes
of Health (NIH) Tissue Chips Program.

In light of such progress, we believe FDA must ensure its regulatory framework and evaluation programs create a path for integrating innovative human-based nonclinical approaches.

For the reasons outlined above, we respectfully urge the FDA to modify the attached regulations to clearly allow for use of modern human-based nonclinical approaches and establish a qualification program for “in vitro
and computational” methods.

Thank you for your consideration of our views. We respectfully request a thorough written response by August 1, 2019.



*Members of Congress*


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