History of the Food and Drug Administration
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the "United States Pharmacopoeia" or the "National Formulary". The act also banned "misbranding" of food and drugs. The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.
Manhattan Institute for Policy Research
Since 2006, the Institute's Project FDA has been at the forefront of advocating for FDA reform. With modern medicine on the cusp of a radical transformation due to breakthroughs in precision medicine, the FDA has struggled to adapt its regulations to new scientific advances. Senior fellows Paul Howard, Peter Huber, and Tom Coburn have all argued that the FDA can be a bridge for innovation, rather than a barrier, getting better medicines to patients, faster, without sacrificing safety. In October 2015, the Institute ran a full-page advertisement in the New York Times, reading, "Everyone will be a patient someday". The ad included the signatures of over a dozen industry leaders, all in support of the passage of the 21st Century Cures Act, which was signed into law by President Obama just over a year later, in December 2016.