Food and Drug Administration Federal regulatory agency profile

By Lolly Adair

The Food and Drug Administration was established on June 30, 1906, “origins as a federal consumer protection agency began with the passage of the Pure Food and Drug Act in 1906. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace.”
This is Harvey Washington Wiley the chief chemist of the Bureau of Chemistry of the U.S. Department of Agriculture. He vigorously advocated for federal public health protection.

The 1906 Act was passed thanks to the efforts of Harvey Washington Wiley, who at the time was chief chemist at the FDA's predecessor, the Bureau of Chemistry of the U.S. Department of Agriculture. It was also in response to the public outrage at the shockingly unhygienic conditions in the Chicago stockyards that were described in Upton Sinclair’s book “The Jungle."

Eventually, the position of chief chemist of the Bureau of Chemistry evolved into that of the commissioner of food and drugs.

Acting Commissioner of FDA (current leader)- Stephen Ostroff, M.D.

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counter terrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Addresses market failures by regulating public goods to inform the public about what is safe for them to use in cosmetics, food, and medicine. They also fund research to get science-based information and try to make medical products affordable since almost everyone needs it.

Current Issues Being Addressed by the FDA

Passed on March 2, 2017

The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
“The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs,” said Dara Corrigan, FDA’s associate commissioner for global regulatory policy.

Passed on March 3, 2017

The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition.

“Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

Passed on Feb 3, 2017

The U.S. Food and Drug Administration today permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Mucopolysaccharidosis Type I(MPS I), Pompe, Gaucher and Fabry. It is the first newborn screening test permitted to be marketed by the FDA for these disorders.

LSDs are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body’s cells are not at normal levels or functioning properly. According to the U.S. Department of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children, MPS I, Pompe, Gaucher and Fabry occur in approximately 1 in 1,500 to no more than 1 in 185,000 newborns and children, depending on the disorder. If not detected and treated in a timely manner, these disorders may cause organ damage, neurological disability or death.

Source: www.fda.gov

"U S Food and Drug Administration Home Page." U S Food and Drug Administration Home Page. N.p., n.d. Web. 11 Mar. 2017.

All images were found on Google Images

"Google Images." Google Images. N.p., n.d. Web. 11 Mar. 2017.

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