FYI: THE FDA IS NOT A-OK - Top F.D.A. Vaccine Official Resigns, Citing Kennedy’s ‘Misinformation and Lies’

The Food and Drug Administration (FDA) has been crucial in protecting public health in the United States for over a century. Here are some of the most noteworthy actions and milestones in its history:

1906 – Formation of the FDA (Pure Food and Drug Act)

The FDA was born out of public outcry over unsafe food and medicine, largely thanks to Upton Sinclair’s novel The Jungle.

The Pure Food and Drug Act prohibited the sale of misbranded or adulterated food and drugs and led to the creation of the FDA’s earliest form.

1938 – Federal Food, Drug, and Cosmetic Act

• Approved after more than 100 people died from a toxic ingredient in Elixir Sulfanilamide.

• Required drugs to be proven safe before marketing.

• Gave the FDA authority over cosmetics and medical devices for the first time.

1962 – Drug Efficacy Amendment (Kefauver-Harris Amendment)

• It passed after the thalidomide disaster in Europe, which caused birth defects.

• The required drugs must be proven effective and safe before approval.

• Introduced stricter clinical trial regulations and informed consent for patients.

1987–1992 – HIV/AIDS and Accelerated Drug Approvals

• In response to the AIDS crisis, the FDA began accelerating drug approval processes for life-threatening conditions.

• Approved AZT (zidovudine), the first major AIDS treatment, in just 20 months.

• Introduced Expanded Access Programs to allow patients early access to experimental drugs.

1997 – FDA Modernization Act

• Streamlined drug approval and expanded access to experimental treatments.

• Encouraged innovation in drug and biologics development, particularly in oncology.

  
  2011 – Food Safety Modernization Act (FSMA)

  Shifted the FDA’s focus from reacting to contamination to preventing it.

  Strengthened oversight of both domestic and imported food.

2017 – First Gene Therapy Approved

• The FDA approved Kymriah, the first gene therapy for a type of leukaemia.

• Marked a new era in personalized medicine and biotech innovation.

2020–2021 – COVID-19 Vaccine Emergency Use Authorizations

• The FDA granted Emergency Use Authorizations (EUAs) for COVID-19 vaccines like Pfizer-BioNTech and Moderna.

• Played a central role in vaccine safety monitoring, public communications, and combatting misinformation during the pandemic.

2021 – Approval of Controversial Alzheimer’s Drug (Aduhelm)

• Approved despite conflicting clinical trial results, sparking debate over FDA standards, transparency, and relationships with pharma.

Tobacco Regulation

• The FDA has been authorized to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act since 2009.

• Implemented rules on flavoured tobacco, graphic warning labels, and e-cigarette oversight.