FDA History in One Little Pill


FDA history in a little pill

The Pill that Made FDA History

An important piece of FDA history, the birth control pill, was discussed in The Science Section of the New York Times in an excellent article by Gardiner Harris. The 50th anniversary of the little pill’s approval is this month and it revolutionized more than family planning. In the words of Harris: “The pill eventually led the FDA to communicate directly with patients without going through doctors.” This was not appreciated by physicians’ groups at the time, including AMA. The little pill’s impact on FDA was overshadowed by the Thalidomide tragedy which occurred shortly after.

The pill led to FDA using panels of expert to review the safety of drug products, which is now commonplace. FDA now has numerous advisory committees for a number of therapeutic areas- and it is doing a better job of preventing conflicts of interest in their membership. It also led to epidemiological investigations that “would become the model for the future,” according to Harris. The 1960s were an important era for FDA with Thalidomide, the birth controll pill and, of course, the Kefauver-Harris Amendments that led to the modern era of clinical trials. We seldom get well-written articles that cover FDA history that can be read in a short matter of 5-10 minutes. Highly recommended reading.

The Pill That Started More Than One Revolution, by Gardiner Harris, The New York Times

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Update: On 6 May FDA approved a new oral contraceptive, Natazia, a combination hormonal tablet. The FDA News Release tells the story.

Another Update: NY Times columnist Gail Collins weighs in wickedly on the topc with What Every Girl Should Know

And still another Update: Now you too can contribute to FDA history by suggesting an acronym to the Agency. I kid you not. FDA has a link where you can suggest a new acronym or abbreviation for the Agency’s use.

FDA Acronyms

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2 Responses to FDA History in One Little Pill

  1. sid says:

    Hi, Carl, use this if you like. Hope you are well.
    The President’s Cancer Panel has issued its annual report. You can read it at http://deainfo.nci.nih.gov/advisory/pcp/pcp08-09rpt/PCP_Report_08-09_508.pdf. This year the Report examines the relation between cancer and environmental exposure. Many people have arrived at this conclusion before, but this is the top of the medical profession verifying it: They found “the true burden of environmentally induced cancer has been grossly underestimated.” (from letter to President, front material) And they say we must adopt a precautionary approach to the approval of new chemicals and other forms of environmental exposure.
    As the report says, there is much we do not know about environmental exposure to chemicals and electromagnetic radiation—but we know enough to act. (p. 97) A new chemical needs to be studies and found to be safe before we approve it for uses that will end up in our bodies. We need to study the effects of chemicals and other environmental risks in current circulation. We need to begin systematic biomonitoring to understand the links between the contaminants we store in our bodies and the incidence of cancer. 41% of us, at current rates, will get a cancer diagnosis at some point. We will not beat cancer as long as we continue to expose people to thousands of carcinogens.
    They don’t use these words, but reading the report confirms the sentiment: time to stop the madness.

    • GxP Perspectives says:

      Thanks Sid-
      Readers should check out Sid’s book reviews on the page at the top of the Blog.

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