An article in STAT News (Nov. 22) suggests that the FDA’s drug approval process and reliance on the “gold standard”will undergo “a seismic shift” in the Donald Trump administration. “Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries;…

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A profit-enhancing policy trumps public safety & scientific integrity In the mid-1980s, the U.S. executive branch was persuaded that the biotechnology industry would boost the U.S. economy out of its doldrums. To accommodate this newly developing industry, the executive branch gave the industry “regulatory relief” in 1992. The US government public health safety policy shifted…

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