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Pharmaceutical companies are promoting off-label uses in the wake of a controversial legal decision.
Pharmaceutical companies are promoting off-label uses in the wake of a controversial legal decision, according to a report filed by Robert Temple, M.D., associate director of medical policy for the Food and Drug Administration's Center for Drug Evaluation and Research.
"I have received over 40 [journal] reprints that were disseminated by manufacturers, but not submitted to FDA for pre-dissemination review, as the Food and Drug Administration Modernization Act requires, including three entire supplemental journal issues," Temple said.
Although many of those reprints were later submitted in accordance with FDA standards, eight of those reprints were sent directly to physicians, and others were distributed at national medical meetings without being submitted for review. Companies that distributed six of the reprints quoted a July 1998 court ruling as the basis for their actions.
The ruling (Washington Legal Foundation vs. Friedman) said that FDA regulations restricting pharmaceutical companies from promoting some off-label uses information violate freedom of speech and, therefore, are unconstitutional.
The decision, which was appealed but upheld in February of this year, was made after Congress had already voted to pass FDAMA. The Act includes regulations that now appear to be contrary to the court's ruling.
FDAMA's Sec. 401, for example, requires pharmaceutical companies to preview off-label uses information with the FDA so that the agency can ascertain that the materials are unabridged and from peer-reviewed journals and that the off-label use is clearly identified as being an unapproved indication. Companies must also demonstrate intent to file information from the articles for a supplemental indication.
However, Temple said that most of the companies disseminating journal articles about off-label uses have given "no indication of their intent to study the new uses discussed." Only 15 of the 40 reprints received by the FDA appear to be backed up by plans to develop approved indications for the uses described in the articles, according to Temple.
The Food and Drug Administration has argued that the court ruling should not undermine FDAMA, which was ruled on by Congress. However, the judge who ruled on the case responded that FDAMA was not exempt from the court's findings last July. Meanwhile, pharmaceutical companies are promoting off-label uses in ways that were forbidden less than a year ago. PR