The FDA Approval Process

Paper Summary:

The paper relates that the FDA has been accused of being too slow as well as lacking oversight and in need of even more periodic reviews of previous approvals. The paper discusses the pressure from patient groups as well as doctors and pharmaceutical companies to expand the FDA approval and testing process to include experimental drugs. The paper devotes time to the politicization of the FDA and the accusations of bias towards the pharmaceutical companies. The paper also reveals that many American pharmaceutical companies are now outsourcing their clinical trials, which might make it more difficult for the FDA to follow every step of the trial method and results.

From the Paper:

"Just what does the FDA do? Government documents state that the FDA seeks to protect the public health by ensuring the purity and security of foods; the safety and effectiveness of drugs, medical devices, biological products, and radiation-emitting products; and the safety of cosmetics. The FDA oversees the review and approval of new medicines and medical devices. It also monitors the safety of dietary supplements, though it does not review and approve the supplements before they are sold.
"The FDA helps to ensure that people receive accurate information about the foods and drugs that they use. The agency calls for the truthful description of product benefits and risks and for safety and honesty in packaging. In fact, the information about contents and dosage found on food packages was developed by the FDA."

Sample of Sources Used:

• Ceccoli, Stephen J.: "POLICY PUNCTUATIONS AND REGULATORY DRUG REVIEW" Journal of Policy History (2003) Vol. 15, issue 3
• Deyo, Richard: "Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice:" MedcapeToday, May 17, 2004 www.medscape.com/viewarticle/474285
• Gatty, Bob: "Implications far-reaching in FDA approval process" Dermatology Times, Jan 2005 v26 i1
• Hennessey, William T.,. Goodson, Timothy C., Houoser, Elizabeth; and Griffin, Andrew S.: "Has the withdrawal of rofecoxib (Vioxx) affected your prescribing habits and your opinion of the FDA's drug approval process?" Urology Times, Feb. 2005, vol. 33, 1. 2
• Lustgarten, Abraham: "Drug Testing Goes offshore" FORTUNE, Aug. 8, 2005

More papers on The FDA Approval Process:

• Term Paper # 124703 : "The FDA and the Pharmaceutical Industry"
• Analytical Essay # 132641 : "The Marketing of Zoledronic Acid (Zometa)"
• Case Study # 118787 : "FDA Process to Approve Viagra"

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