Amy Dow Quoted in “Individuals Compassionate Use: Concerns for Drug Manufacturers Considering Participation”

Wolters Kluwer Law & Business White Paper April 2015

Amy K. Dow, a Member of the Firm in the Health Care and Life Sciences practice, in the firm's Chicago office, was quoted in Wolters Kluwer Law & Business White Paper, in “Individuals Compassionate Use: Concerns for Drug Manufacturers Considering Participation,” by Harold M. Bishop.

Following is an excerpt (see below for a PDF of the full article):

In an interview with Wolters Kluwer Law & Business (WK), Amy K. Dow, a member of Epstein Becker & Green’s Health Care and Life Sciences Practice in Chicago, indicated that “the current statutory and regulatory provisions provide an appropriate framework to allow individual patient access to investigational products.” Dow noted, however, “the process … is burdensome and requires a substantial commitment on the part of the treating physician.” Dow added “much of the information currently required to be submitted to FDA is of limited relevance in the context of compassionate use by an individual patient, but was intended for use in approving clinical trials sponsored by product manufacturers seeking approval of their products.” Dow also believes that this burden may deter some treating physicians from making an expanded request for a patient.

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