FDA ORg

My interpretation of the FDA. c. 2009.

This was a group project that suggested the FDA give up regulating food. Presentation is and presentation background brief (cowritten with Anthony Hopper and Eliott Bosslet) is copy/pasted below.

Legislation Review

            The FDA is an ever-evolving agency that is constantly changing due to technology and the advancement of science.  A majority of the amendments are developed to modify previous laws and regulations that were in place.  Currently the FDA is working on the Food and Drug Administration Amendments Act of 2007.  President George W. Bush signed into law H.R. 358 on September 27th, 2007.  This new law focuses on drugs and devices.  It adds the Prescription Drug User Fee Act and also the Medical Device User Fee and Modernization Act.  Another area that the new amendment concentrates on is that of children with the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.  With the signing of this act the FDA is hoping to make considerable advances for not only those who develop medical products, but also for those who use them.

Another law that was just signed on June 22nd, 2009 by President Obama is The Family Smoking Prevention and Tobacco Control Act.  This new law adds to the FDA’s already robust list of regulatory standards.  It will focus on cracking down on the appeal of cigarettes to children, making the tobacco industry more clear on their marketing, and also give the FDA power to make changes in the tobacco industries products.

 

Intro/background

            The FDA is the oldest comprehensive consumer protection agency in the U.S. Federal Government, and it reports to The U.S. Department Health and Human Services.  Its history can be traced all the way back to 1820 when eleven scientists met in Washington, D.C., to establish the U.S. Pharmacopeia, which was the first collection of drug standards for the U.S.  Over the years it has grown and branched out to a wide variety of regulatory fields varying from cosmetics to Veterinary products.  Some of the major amendments and laws are as followed: 1906 the Food and Drugs Act, 1938 the Food, Drug, and Cosmetic Act, 1968 the Animal Drugs Amendment, 1976 Medical Device Amendment, 1997 the Current FDA Modernization Act, and the most recent in 2009 is The Family Smoking Prevention and Tobacco Control Act.

The FDA currently regulates: biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronic products, veterinary products, and now tobacco products.  The FDA’s current budget is approximately $2.7 billion, they employee around 11,000 individuals, and they oversee $1.5 trillion in foods, drugs, and other products.  Due to their diverse and broad regulatory standards we believe that they are spread too thin and are not able to accurately regulate all of these products.  That being said we propose two goals for the FDA, one long-term goal and one short-term goal.  For the short-term we recommend that the FDA increase their budget and for the long-term we recommend that the FDA is broken up into two different entities The U.S. Department of Health and Human Services take everything that pertains to humans: biologics, cosmetics, drugs, medical devices, radiation-emitting electronic products, and tobacco; and the Department of Agriculture takes foods and veterinary products.