Tag:Right to Try
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.
Establishing Expanded Use Programs
The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.