FDA recently released a Proposed Rule requiring that clinical studies conducted outside the U.S. be conducted in accordance with good clinical practice (GCP). FDA intended the Proposed Rule to (i) update the standards for FDA acceptance of data from clinical studies conducted outside of the U.S. and (ii) help ensure the protection of human subject and the quality and integrity of data from the clinical trial studies.
In their comments to the Proposed Rule, medical device companies agreed with the overall purpose of the Proposed Rule but found it to be premature. They also critiqued the Proposed Rule’s specific requirements and expressed concerns about its cross-border implications. Below are four main points the companies raised:
- International Cooperation. Companies and trade groups repeatedly expressed concern that other nations would view the Proposed Rule as the U.S. unilaterally imposing domestic standards on international device regulators and the international clinical community. Comments called for FDA to proactively establish a forum of international regulators and industry representatives to develop common definitions and harmonized guidelines on GCP for medical devices. Harmonized international guidelines on GCP for medical devices do not exist and companies stressed that the Proposed Rule should not be finalized until harmonized international medical device GCP guidelines and medical device definitions have been established.
- Jurisdiction. Companies pointed out concerns revolving around the “practical aspects of imposing obligations impliedly required by the proposed rule on foreign investigators and sites,” including FDA’s statutory authority and jurisdictional reach. Foreign privacy laws, for example, may limit the ability of investigators to acquire and provide data required by the Proposed Rule.
- Greater Onus on the Clinical Study Sponsor. Several companies argued that the requirements placed on the manufacturer are higher for overseas studies than domestic studies and no rationale existed for these increased requirements. One company noted that in the U.S., “a sponsor plays little to no role in ensuring the adequacy of an IRB,” but that the Proposed Rule requires the clinical study sponsor to be “responsible to verify and document the adequacy of a foreign Independent Ethics Committee (IEC).” The companies argued that the Proposed Rule fails to recognize that sponsors do not have the authority to determine the adequacy of an IEC and that sponsors would be legally challenged to meet the onus the Proposed Rule would place on them.
- Delay in Bringing a Device to the U.S. Market. Finally, companies and trade groups noted that without harmonized guidelines and international practices the Proposed Rule “will stifle critical innovation and slow the path of new products to patients and clinicians who need them most.” Companies would be forced to selectively choose markets to enter and entry into the U.S. market could be delayed if the overseas clinical trial data requirements were more burdensome or disparate than requirements in other countries.
If you have questions regarding the Proposed Rule or FDA requirements regarding clinical trial data, please contact one of the authors.