WLF Finds Faults With FDA Modernization Act

In a motion for summary judgement filed November 24, the WashingtonLegal Foundation has said that the recently-passed US Food and Drug Administration Modernization Act (Marketletters passim) does not settle the First Amendment issues raised in its suit against the agency, filed in 1993, on the dissemination of off-label drug use information. WLF chief counsel Richard Samp told the Marketletter that the new law does not take effect for a year and does not address continuing medical education.

Unless the FDA wants to concede defeat now, there is still a year's worth of current policy left, he noted, adding that the Act is confined to distribution of materials.

Additionally, Mr Samp told the Marketletter, the kind of pre-clearance called for under the Act is not really consistent with First Amendment practice. The Act allows the FDA to demand to see any material firms are contemplating distributing, he said, and the actual practice will depend on eventually implementing regulations.