Nathan Brown Interviewed by MCC on FDA and Medical Device Regulatory Regimes

Akin Gump health care and life sciences partner Nathan Brown was interviewed by The Metropolitan Corporate Counsel for its article “Regulation in the Medical Device Industry: FDA insider lays out the issues,” which covered such topics as lessons learned from his time in government (Brown served as special assistant to the chief counsel at the Food and Drug Administration), enforcement regimes, laboratory-developed tests and supply chain integrity.

Brown discussed, among other subjects:

• Current developments: “The device industry is emerging from a period of significant frustration with the FDA, a high level of distrust and, whether accurate or not, a feeling that the agency’s performance was inconsistent…With more resources now available to the FDA and more formalized procedures, we’ve seen overall improvement in the regulatory environment and in the relationship between the industry and the agency.”
• Lessons learned from government service: “[I]t is important to keep in mind that various government agencies often pursue different, sometimes even conflicting, yet equally legitimate, missions to meet their core objectives…Companies have to be aware of a matrix of governmental interests as they determine how to advance their own strategy and need to be able to demonstrate somewhat different benefits and results in each case.”
• State vs. federal enforcement regimes: “Many states have incorporated the Federal Food, Drug, and Cosmetic Act into their own state laws, with the result that its provisions may be enforced at the federal or state levels. In recent years, I have noted increasing instances in which state interpretations of the FD&C Act have deviated from those of the FDA or DOJ, which also enforces the FD&C Act. These potential differences lead to very significant challenges for companies.”

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