Amy K. Dow, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Chicago office, was quoted in Wolters Kluwer's Health Law Daily Wrap Up, Strategic Perspectives,in "Compassionate Use: A Look into Goldwater Institute v. HHS and ‘Right to Try’ Legislation," by Harold Bishop.

Following is an excerpt:

With the help of expert commentary from … Amy Dow, a member in the Chicago law office of Epstein Becker & Green, P.C., this Strategic Perspective will examine the FOIA case (Goldwater Institute v. HHS) and S. 204, which has bipartisan sponsorship in the House of Representatives, and is expected to pass and be signed into law by President Trump. …

Dow believes the “FDA’s denial of the FOIA request by the Goldwater Institute is not surprising given FDA’s regulations protecting the confidentiality of information submitted in support of an investigational new drug application, and FDA’s practice of carefully protecting manufacturers’ proprietary information submitted in support of an application.” Dow explained that “FDA’s policies reflect an understanding of the significant value to manufacturers of the proprietary information they submit to the agency and the potential harms to manufacturers’ interests that may result from its disclosure. Dow continued, “To encourage full disclosure to FDA by manufacturers of the information required to assess the safety and effectiveness of a product, manufacturers must be confident that the agency will protect that information from disclosures that might adversely impact their interests, such as providing an advantage to their competitors or influencing their stock prices.”

Dow believes that “[t]he information sought by the Goldwater institute…is likely inextricably combined with the manufacturer’s proprietary information and the health information of the two individuals who received access to the drug. In light of the protections afforded to this information under FOIA’s exemptions, FDA’s denial of the request appears to be warranted.” …

Dow, however, grants that the Goldwater Institute is entitled to seek information supporting its policy objectives, but cautions that “these interests must be balanced against the interests of the submitter of the data and the government’s interest in protecting proprietary information to enable it to obtain access to the information it needs to fulfill its mandate.”

Dow concluded that “[t]he claimed exemptions upon which FDA relies are appropriate based on the nature of the information sought by the Goldwater Institute.” She describes the significant question for determination by the Arizona district court as “whether there is any portion of the information the Goldwater Institute is seeking that is not subject to the exemptions for trade secrets and confidential commercial or financial information, deliberative privilege, and personal privacy asserted by FDA?”

Based upon the facts presented in the institute’s motion for summary judgement, Dow “expects that FDA’s denial of the institute’s request will be upheld at the district court level with regard to many of the records sought, and that only a limited number of records that are not within the scope of FDA’s claimed exemptions or from which information subject to these exemptions can be redacted will be ordered to be released.”


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