Former FDA Official Philip Desjardins Comments on FDA Enforcement and Physician Obligations in Drug Trials
Philip Desjardins, Life Sciences & Healthcare Regulatory partner and former official with the FDA’s Center for Devices and Radiological Health (CDRH), was quoted in the Glance article, “FDA scrutiny of unapproved CXL trials reveals critical lapses in patient safety and regulatory adherence.” The piece examines recent FDA warning letters issued to ophthalmologists who conducted unapproved cross-linking (CXL) procedures without the required investigational new drug applications.
Desjardins, who spent nearly a decade at Johnson & Johnson in its MedTech business and at the FDA’s CDRH focusing on pre-market and post-market issues, said that confusion over regulatory requirements is not a strong legal defense. “The FDA would say that one of your responsibilities as an investigator is to fully understand the regulatory requirements around these products and apply the regulations appropriately,” he noted. He further advised clinicians to look beyond minimum compliance and proactively consider how the agency may respond: “I generally start with what the FDA would like to see in this situation and what we think would be reasonable to go back to them with.”
