<P> By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis . The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent . </P> <P> President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938 . The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent . Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription - only" drugs was securely codified into law by the 1951 Durham - Humphrey Amendment . These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs . </P> <P> In 1959, the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug--marketed for treatment of nausea--during their pregnancies, Considering the US was largely spared that tragedy because Dr. Frances Oldham Kelsey of the FDA refused to authorize the medication for market, the 1962 Kefauver - Harris Amendment to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority . The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety . This marked the start of the FDA approval process in its modern form . </P> <P> These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market . One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch - Waxman Act" after its chief sponsors . The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug . For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand - name drug . This act has been credited with in essence creating the modern generic drug industry . </P>

Who provides the lead role in monitoring and enforcing the relevant state food act and regulations