ArtsAutosBooksBusinessEducationEntertainmentFamilyFashionFoodGamesGenderHealthHolidaysHomeHubPagesPersonal FinancePetsPoliticsReligionSportsTechnologyTravel

What is the FDA?

Updated on July 5, 2012

Protecting and Promoting Your Health

If you have ever eaten any food or taken any medicine or used any piece of medical equipment...you must have heard of the FDA. We see statements from the FDA all around us. Supplements found on the vitamin shelf in your local pharmacy say "These statements have not been evaluated by the FDA." The FDA requires that. Prescription bottles that come into my pharmacy all say "May not be dispensed without a prescription." The FDA requires that. Advertisements for drugs on TV run through a seeming endless (and sometime hilarious) list of possible side effects. Why? The FDA requires it. Food products all contain nutritional information for consumers because...you guessed it...the FDA requires it!

But who is the FDA? What is this organization? Where did it come from and what do they do?

As a pharmacist, my interest in the FDA is especially related to the testing and approving of prescription and non-prescription medications. In this article I will provide a brief review of the FDA in general, as well as some particulars about this agency with respect to the drug approval process.

The FDA (Food & Drug Administration) is the U.S. agency which grew out of the 1906 Food and Drug Act signed into law by then President Theodore Roosevelt. Originally known as "Wiley's USDA Bureau of Chemistry" (after Harvey Washington Wiley, the chief proponent of this organization), the name was eventually changed to the Food, Drug and Insecticide organization (hopefully they kept these products separated!!) and then to the Food and Drug Administration (FDA) in 1930. The Food and Drug act was fairly limited in terms of what it could do. With the growth of interstate commerce and the production of pharmaceutical products, stronger controls were needed. This was made especially evident by the tragic deaths of over 100 people due to the contamination of Elixer Sulfanilamide in 1937. Thus, in 1938, the President signed into law the Food, Drug and Cosmetic Act, greatly expanding the authority of the FDA over marketed drugs in the U.S.

By the way, it was an amendment to the Food, Drug and Cosmetic Act in 1951 known as the Durham-Humphrey Amendment ("Durham" was a pharmacist) that created the category of "prescription only" medications in the U.S.

In this article I will briefly highlight some of the basics about the FDA along with some specific information about their roll in the prescription drug approval process.

FDA Home Page
FDA Home Page | Source

LOCATION AND CONTACT:

The central headquarters for the FDA is located in Silver Spring, Maryland, about 30 minutes north of Washington DC on 10903 New Hampshire Avenue.

Their official address is:

Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Their Phone Number for general inquiries is: 1-888-INFO-FDA (1-888-463-6332)

FAX: 301-847-3531

Website: www.fda.gov


The FDA has all the Social Networks Covered!

Source

FDA OVERSIGHT:

The FDA is given the responsibility of overseeing a wide variety of U.S. industries.

The primary areas of responsibility and oversight include:

  • Food
  • Drugs
  • Medical Devices
  • Vaccines, Blood products, Biologic Drugs
  • Animal & Veterinary medicines and food
  • Cosmetics
  • Radiation Emitting Products
  • Tobacco Products


ADMINISTRATIVE STRUCTURE:

The "head" of the FDA is known as the Commissioner of Food and Drugs, and this person reports to the head of Health & Human Services.

These commissioners are typically a Medical Doctor, but are not required to be.

The current commissioner is Margaret A. Hamburg, MD.

The commissioner is appointed by the President upon the advice of the Senate.

According to the FDA website, the FDA currently employs about 11,516 individuals (2009 is the most recently posted data).

Organized around the Commissioner of Food & Drugs are a multitude of "offices" and "centers" each with a "head" leading the organization and staff involved. For example, there is the:

  • Office of Counselor to the Commissioner
  • Office of Legislation
  • Office of Policy and Planning
  • Office of Foods
  • Office of Medical Products and Tobacco

Beneath this last office (in bold), which is currently run by Stephen Speilberg (no, not the film director), are 4 "centers" which are the:

  • Center for Devices and Radiological Health
  • Center for Biologics Evaluation and Research
  • Center for Drug Evaluation and Research
  • Center for Tobacco Products

For a full list of the organization of the FDA, CLICK HERE.


CENTER FOR DRUG EVALUATION AND RESEARCH

The most important branch of the FDA, with respect to the field of pharmacy and medicine, is the Center for Drug Evaluation and Research (CDER).

This is an enormous agency, employing approximately 3,000 full time equivalent employees.

The current head of the Center is Janet Woodcock, MD.

The CDER is divided into a large number of offices, such as the:

  • Office of Pharmaceutical Science (OPS)
  • Office of Biotechnology Products (OBP)
  • Office of Testing and Research (OTR)
  • Office of Generic Drugs (OGD)
  • Office of New Drug Quality Assessment (ONDQA)
  • Office of Regulatory Policy (ORP)
  • Office of New Drugs (OND)


NEW DRUGS AND THE FDA

Manufacturers wishing to research and market new drugs in the U.S. must receive the approval of the FDA.

The process involves submitting a series of applications to the Center for Drug Evaluation and Research (CDER).

The process involves - in a very simplified form - 3 basic steps:

1) The Investigational Step - This requires the submission of an IND (investigational new drug) application. Once approved, the next step is...

2) Clinical trials - the manufacturer can now begin the sometimes lengthy and expensive process of testing the drug in human trials. Finally, if all seems positive, they can...

3) New Drug Application - Also known as the NDA. This is the application to get final approval of their new drug and bring it to the U.S. market for sale, either as a prescription or OTC product.


Comments

    0 of 8192 characters used
    Post Comment

    • Terrancejose profile image

      Terrancejose 

      6 years ago

      Quite useful hub...

    working

    This website uses cookies

    As a user in the EEA, your approval is needed on a few things. To provide a better website experience, hubpages.com uses cookies (and other similar technologies) and may collect, process, and share personal data. Please choose which areas of our service you consent to our doing so.

    For more information on managing or withdrawing consents and how we handle data, visit our Privacy Policy at: https://hubpages.com/privacy-policy#gdpr

    Show Details
    Necessary
    HubPages Device IDThis is used to identify particular browsers or devices when the access the service, and is used for security reasons.
    LoginThis is necessary to sign in to the HubPages Service.
    Google RecaptchaThis is used to prevent bots and spam. (Privacy Policy)
    AkismetThis is used to detect comment spam. (Privacy Policy)
    HubPages Google AnalyticsThis is used to provide data on traffic to our website, all personally identifyable data is anonymized. (Privacy Policy)
    HubPages Traffic PixelThis is used to collect data on traffic to articles and other pages on our site. Unless you are signed in to a HubPages account, all personally identifiable information is anonymized.
    Amazon Web ServicesThis is a cloud services platform that we used to host our service. (Privacy Policy)
    CloudflareThis is a cloud CDN service that we use to efficiently deliver files required for our service to operate such as javascript, cascading style sheets, images, and videos. (Privacy Policy)
    Google Hosted LibrariesJavascript software libraries such as jQuery are loaded at endpoints on the googleapis.com or gstatic.com domains, for performance and efficiency reasons. (Privacy Policy)
    Features
    Google Custom SearchThis is feature allows you to search the site. (Privacy Policy)
    Google MapsSome articles have Google Maps embedded in them. (Privacy Policy)
    Google ChartsThis is used to display charts and graphs on articles and the author center. (Privacy Policy)
    Google AdSense Host APIThis service allows you to sign up for or associate a Google AdSense account with HubPages, so that you can earn money from ads on your articles. No data is shared unless you engage with this feature. (Privacy Policy)
    Google YouTubeSome articles have YouTube videos embedded in them. (Privacy Policy)
    VimeoSome articles have Vimeo videos embedded in them. (Privacy Policy)
    PaypalThis is used for a registered author who enrolls in the HubPages Earnings program and requests to be paid via PayPal. No data is shared with Paypal unless you engage with this feature. (Privacy Policy)
    Facebook LoginYou can use this to streamline signing up for, or signing in to your Hubpages account. No data is shared with Facebook unless you engage with this feature. (Privacy Policy)
    MavenThis supports the Maven widget and search functionality. (Privacy Policy)
    Marketing
    Google AdSenseThis is an ad network. (Privacy Policy)
    Google DoubleClickGoogle provides ad serving technology and runs an ad network. (Privacy Policy)
    Index ExchangeThis is an ad network. (Privacy Policy)
    SovrnThis is an ad network. (Privacy Policy)
    Facebook AdsThis is an ad network. (Privacy Policy)
    Amazon Unified Ad MarketplaceThis is an ad network. (Privacy Policy)
    AppNexusThis is an ad network. (Privacy Policy)
    OpenxThis is an ad network. (Privacy Policy)
    Rubicon ProjectThis is an ad network. (Privacy Policy)
    TripleLiftThis is an ad network. (Privacy Policy)
    Say MediaWe partner with Say Media to deliver ad campaigns on our sites. (Privacy Policy)
    Remarketing PixelsWe may use remarketing pixels from advertising networks such as Google AdWords, Bing Ads, and Facebook in order to advertise the HubPages Service to people that have visited our sites.
    Conversion Tracking PixelsWe may use conversion tracking pixels from advertising networks such as Google AdWords, Bing Ads, and Facebook in order to identify when an advertisement has successfully resulted in the desired action, such as signing up for the HubPages Service or publishing an article on the HubPages Service.
    Statistics
    Author Google AnalyticsThis is used to provide traffic data and reports to the authors of articles on the HubPages Service. (Privacy Policy)
    ComscoreComScore is a media measurement and analytics company providing marketing data and analytics to enterprises, media and advertising agencies, and publishers. Non-consent will result in ComScore only processing obfuscated personal data. (Privacy Policy)
    Amazon Tracking PixelSome articles display amazon products as part of the Amazon Affiliate program, this pixel provides traffic statistics for those products (Privacy Policy)