Food And Drug Administration Case Study

The FDA or Food and Drug Administration was created to protect the public's health, by making sure the safety and security in drugs and food is satisfactory. Since the founding of the FDA till present time, the organization has failed to uphold its core mission policies and values to successfully protect the citizens of the United States.

The FDA displays its mission objectives and policies clearly on its government website for the public’s perusal. According to the FDA’s own website, the mission statement reads:

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;…The FDA is also responsible for

However, in 1992, during the Clinton administration, the FDA was changed in a fundamental way that ultimately paved the avenue for the corruption that inhibits the organization from executing its duties today. During this time, the FDA appealed to congress stating that it lacked the proper funding to adequately and efficiently monitor and approve the vast amount of new drug petitions in a safe reasonable timeframe. The solution: congress enacted PDUFA or the Prescription Drug User Fee Act. This act allowed the FDA to charge exorbitant amounts of money in application and renewal fees in new and existing medications (source): The 2017 FDA new drug application fee is $2,038,100; new drug establishment fee is $512,200; annual product registration fee is $97,750 (Mezher pars. 1). The establishment fee is a fee that is only charged if the new drug gains approval; this half-a-million dollar fee gives FDA incentive to approve more drugs than disapprove regardless of drug safety. According to Reuters, “U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light--more than double the previous year…. ”(source). The transfer of funds from the big Pharma industry to the FDA is a conflict of interest in the government agency’s ability to objectively oversee and regulate the drug

However there have been many cases that inversely conclude otherwise. For example, take the drug telithromycin (brand name Ketek). Ketek was a drug approved by the FDA to treat mild to moderate respiratory infections such as bronchitis, sinusitis, and pneumonia. During testing it was found to cause severe liver damage and possibly liver failure. After the clinical testing was finished, to produce more polished results, doctors tampered with the data c. A routine FDA inspection found at least 400 cases of fraud in patient enrollment. Despite knowing the fraudulent data, the FDA went ahead and presented it to the advisory committee for approval. It was voted 11-1 and passed; the known fraudulent data was never reported to the committee. Because of this false study, the drug stayed on market way longer than it should have. (Source E) The complete list of FDA issues with Ketek