Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 44

A century or two ago, the requirements for the safety and efficacy of drug products were either non-existent or poorly defined at best. In 1906, the Pure Food and Drugs Act (FDA) prohibited interstate commerce of mislabeled and adulterated drugs and food within the United States. This covered some safety aspects of drugs but not efficacy. The FDA had, at that time, no jurisdiction or control of efficacy claims made for drugs. In 1912, the law was changed to cover false and fraudulent claims made for drugs. However, the law did not mandate safety and, in effect, unsafe products could be and were marketed. The FDA could not seize unsafe drugs and was limited only to issuing public warnings.

In 1937, a company in the United States marketed elixir of sulfanilamide, which contained diethylene glycol (similar to antifreeze) as a solvent. More than 100 people (including many children) died from this product due to kidney failure caused by the solvent. Because the law did not require safety testing for drugs, the company had done none. As a result of this, the Federal Food, Drug and Cosmetic Act was passed into law in 1938. This law required safety testing to be performed and submitted to the FDA in a New Drug Application (NDA). Additional laws were passed in the 1940s requiring testing for purity, strength, and quality of many drugs.

The next major event was the thalidomide disaster of the early 1960s, when the NDA for thalidomide was valiantly opposed by Dr. Frances Kelsey at the FDA because of insufficient safety information despite strong pressure to approve it. The product was intended for use in pregnant women to prevent morning sickness and was widely available for this use in Europe and was even sold OTC in Germany. Though never marketed in the US, thalidomide was used in the investigational setting in the US. By 1962, the terrible teratogenic (birth defect) aspect of the drug became known as babies were born, mostly in Europe, with severely deformed arms and legs (phocomelia).

In 1962, the Kefauver-Harris Amendment became law and introduced the modern era of drug regulation. Drug manufacturers now had to demonstrate to the FDA both safety and efficacy before marketing a new drug. In 1971, the National Drug Experience Reporting System was begun as was the publication of “The FDA Drug Bulletin” to alert physicians and pharmacists to drug issues. In 1985, the regulations on AE reporting for marketed drugs were strengthened, and new requirements for Investigational New Drug Applications (INDs) were introduced. Over the years, the FDA has had multiple reorganizations and alterations in its structure and function as the overseer of drug safety and efficacy in the US. The result is the complex system of AE collection, analysis, and reporting that we know today.