The recent US Supreme Court decision striking down a state ban on liquor price advertising could have implications for the dissemination of information to doctors on off-label drug uses, Andrew Krulwich of Wiley Rein & Fielding told the US Food and Drug Law Institute's annual Pharmaceutical Update meeting this month.
There was a split decision on the matter and the overall significance in other areas will have to be decided by further litigation, he said, but it is clear that government restrictions directed towards a lack of fair balance are acceptable, while curbs on advertising aimed at keeping information from people will attract attention. The decision will certainly have implications for the Washington Legal Foundation's first amendment case against the Food and Drug Administration on curbs of off-label information, he said; the FDA will now probably have to revisit this issue.
Markup On House Bill Soon After the hearings on the House FDA reform bills the House Commerce Committee is now considering language to deal with ambiguities, concerns and policy, said committee counsel John Cohrssen. Markup is likely soon, and a bipartisan process for development will hopefully assure that President Clinton signs the bill. Many of its sections are similar to proposals made five years ago by a Council of Competitiveness committee, including external review, US recognition of foreign data for approval of a New Drug Application and allowing approval for Phase I and II trials by outside bodies. FDA Commissioner David Kessler reminded the panel of the General Accounting Office report that approval times have exceeded user fee goals, but others testified that actual time from first approval for an Investigational New Drug application to final approval has increased. It is clear to the panel, he said, that FDA reform to speed approvals is still needed.
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