Drugs

House Committee Would Limit Foreign Trial Data

David McFarland

— 2 min read
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In a report accompanying its appropriation bill that includes FDA, the House Appropriations Committee says it wants to prohibit FDA from accepting, reviewing, or considering clinical trial data gathered at sites in China, Russia, Iran, or North Korea that support drug or biologic INDs. Five Hogan Lovells attorneys write in an online post that the report “signals the committee’s interest in a significant departure from FDA’s current regulatory framework, which permits reliance on foreign clinical data in support of INDs, subject to good clinical practice and FDA’s ability to validate the data.”

The attorneys write that key features of the report language include:

  • Covered nations: China, Russia, North Korea, and Iran.
  • Scope: All IND applications, amendments, and supplements submitted for drugs and biologics;
  • Effective date: One year after enactment, to allow FDA time to issue implementing guidance and sponsors time to adjust their development strategies; and
  • Rationale: The committee said that China-based sites operate outside of FDA inspection authority, in jurisdictions where patient safety standards, human rights, and independence from state interference cannot be verified. Trials can be conducted three to five times faster in China, which the committee believes incentivizes companies to conduct their trials there, and in turn creates a risk of transferring scientific know-how to a foreign adversary. Presumably, the post says, the committee holds the same concerns with respect to Iran, North Korea, and Russia.

Under existing FDA regulations, the post says, sponsors may rely on foreign clinical studies not conducted under an IND to support IND applications provided that, among other things, the studies are conducted according to good clinical practice, and FDA can validate the data through an onsite inspection. The committee’s position, it says, would eliminate FDA discretion to accept IND-enabling data generated at covered nation sites.

The fate of the appropriations bill itself and the accompanying committee report remain uncertain, the attorneys say, but agencies often take cues from their appropriators even if those directives are never enacted into law. They say that companies with development programs that include or contemplate sites in covered nations might consider the following prudent risk management measures, given the broader legislative trend at both the federal and state levels toward restricting foreign adversary access to biological data and research:

  • Advancing China-based assets. Sponsors planning to rely solely on clinical studies sited in China to support U.S. drug candidates could face real urgency to advance those assets into IND-enabling stages in China, and to file INDs, should a restriction ultimately take effect. Companies should start evaluating whether acceleration of IND-enabling studies in covered nations is feasible for any of their existing assets.
  • Existing INDs with planned amendments and supplements. Sponsors holding active INDs that plan to incorporate covered-nation data in future amendments or supplements should assess their exposure, as any potential restriction like the report language could extend to not only new INDs but to all amendments and supplements.
  • Risk of FDA reevaluating previous IND decisions. Even for INDs that are already in effect, FDA may reevaluate the underlying China-based clinical data at any time with a heightened scrutiny to reflect the changing regulatory landscape. Sponsors of such INDs might consider supplementing them with additional clinical data from other countries to mitigate any risk that such an IND is placed on a partial or full clinical hold.
  • Development program restructuring. Sponsors that currently rely on China-based clinical trials to generate clinical data to support IND submissions might consider restructuring development strategies and potentially exploring early-stage clinical trials in other regions, such as the European Union or Australia.
  • Transaction due diligence. Companies actively evaluating acquisition or in-licensing of China-originated assets should factor potential IND data restrictions into deal diligence and valuation. An asset supported solely by China-based clinical trial data may face a more complex, time-consuming, and costly regulatory path to the U.S. market than anticipated.

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