Tom Ellis - Comment

Dear FDA: On reading your proposed regulation, I would offer the following thoughts: First, please consider amending the definition of ?Newly Acquired Information? to make clear that information not previously submitted to the agency, though previously known to the sponsor, should be eligible for CBE labeling. Drug companies should face a continuing duty to disclose pertinent information to the FDA and the public. Second, please clarify FDA?s expected impact on state tort liability. The proposal?s Federalism section seemed aimed at state labeling requirements, in the regulatory sense, but did not clarify whether preemption would protect a manufacturer from Failure to Warn liability from an injured consumer. Third, please publicize the expected timeframe for the FDA ruling on a Supplemental New Drug Application. If the approval will take an extensive period of time, the FDA should consider allowing companies more leeway to make interim labeling decisions. Fourth, please clarify what degree of certainty is required in determining whether ?causation? exists between a drug or device and any adverse side effects. Thank you, Tom Ellis 3L, College of Law University of Oklahoma Tom Ellis, University of Oklahoma - ...On reading your proposed regulation, I would offer the following thoughts: First, please consider amending the definition of Newly Acquired Information to make clear that information not previously submitted to the agency, though previously known to the sponsor, should be eligible for CBE labeling.