HEARING FOR US FDA BILL THIS MONTH?

17 May 1992

The Senate Labor and Human Res-ources Committee, chaired by Senator Edward Kennedy, is ex-pected to conduct hearings on S 2135, the Food, Drug & Cosmetic Act Safety Amendments, before the end of May.

The House version of the bill, HR3642, has been highly controversial, with President George Bush characterizing it as overregulation and declaring that he would therefore veto it. The inflammatory nature of the House bill and of its provisions as they now stand are such that few of the involved parties are willing to discuss it, according to William Schultz, counsel to the House Energy and Commerce Committee's subcommittee on health. He told a meeting of the Food and Drug Law Institute that officials of the Food and Drug Administration are unwilling to discuss the bill, "even on a technical level," while for its part, the pharmaceutical manufacturers have "just made a strategic decision that they are refusing to talk about it."

Mr Schultz told the meeting that he had never seen a piece of legislation for which the sensitivities were so high. Neverthe-less, he believes that the bill will pass Congress eventually, if not necessarily this year, giving the agency the authority it needs and bringing it up to date. "Ultimately, Congress will be successful in overriding the hyperbole and exaggeration that have fueled the intense opposition to the bill," he said.

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