In a bid to foster better communications between firms and healthcare providers, the Food and Drug Administration (FDA) recently issued a draft guidance, intriguingly titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (SIUU Draft Guidance). This move is believed to be inspired from lyrics of ‘Don’t Go Away,’ a hit song from the nineties by the rock band Oasis, “Say what you say . . . ’cause I need more time . . . just to make things right,” hinting at the perceived need for more in-depth exchanges on the subject.
The FDA has been known for its strict regulations and standards when it comes to the approval and use of medical products. With this draft guidance, questions arise as to whether or not it is aimed at allowing for increased flexibility and dialogue between firms and healthcare providers over unapproved uses of medical products that have already been approved or cleared by the FDA.
For legal professionals, this could signify potential shifts in how firms interact with regulatory standards and could bring about changes in the future of healthcare regulations.
Further information about the FDA’s SIUU Draft Guidance is available here.