The Food And Drug Administration Essay

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

Although the FDA prolongs this process for safety concerns, I personally feel that they should be able to expedite their approval. The reason for expedition is because more and more people are being diagnosed with multiple health issues. Some people are more desperate then others and feel they can benefit from the drug as it is. Therefore, if a person wants to take a drug that has not been approved yet, then they should be able to

Graham made a statement saying, “The people who approve the drug in the first place, within the FDA, and take pride in the fact that they’ve brought a drug to the market - that is their baby. This is their drug.” he says this because the

approvals such as diagnostic test, prescription medicines, clinical trials and however insurers are using to

The Right-to-Try bill is a proposed amendment to the Federal Food, Drug, and Cosmetic Act that would allow those with a terminal illness to have access or the “right to try” investigational drugs which are not approved by the FDA. The Right-to-Try bill, S.204 — 115th Congress (2017-2018): Trickett Wendler Right to Try Act of 2017 was passed by the Senate in August 2017, and now in the House of Representatives for vote in order to be signed into law by President Trump.1

Before the Pure Food and Drug Act, food was produced and sold in a manner that left holes in information necessary for consumers health. Food that today would be considered toxic was sold to everyday consumers. After the Industrial Revolution, it became common for people to buy their food from large food suppliers instead of family farmers. Many consumers weren't aware of the conditions of large industrial factories, but many people's opinions changed once their food’s real quality surfaced to the public by muckraker journalists. The Pure Food and Drug Act was the most perpetual aspect of the Progressive Era: the act offered consumers reassurance of what they ate and took as medication, prevented a great deal of illnesses, and led way to

1-A new investigational new drug application (IND). Expanded access with the new investigational new drug application (IND) involves submitting a new IND or there is an existing IND in effect for the drug, but the sponsor of the existing IND declines to be the sponsor of the access use through a licensed physician (21 CFR 312.310). There is a review period of 30 days, and during this period the treatment cannot proceed (21 CFR 312.40 and 312.305(d)(1)). However, the FDA could notify the sponsor to begin the treatment process earlier. The investigator should have an agreement with the sponsor to supply the investigational product to the patient and the health care professional for treatment.[2]

The Food and Drug Administration dates back to the late 1840s, though it did not adopt that name until 1930. The first act if the FDA as it is known today was officially established in 1906 with the passage of its first piece of legislature. was the passage of the 1906 pure food and drug act, which prohibited the interstate commerce of misbranded food and drugs, and thus establish the FDA . It was established by the government, and thus inherited sits bureaucratic structure. ome of its flaws . Furthermore , the FDA was established as a council to regulate agricultural products through chemical analysis, and thus its structure is incredibly flawed

Nevertheless, important amendment in the FDA act in 2007 empowered the body to establish the risk needs and mitigate strategies that included medical testing. In this arrangement, the support staff ensured pharmacies dispensed drug to the disserving patients only. On the contrary, it was argued that given the strict enforcement by the FDA, some patients would be locked out of the arrangement. Nevertheless, this was played down given the need to maintain safety standards by manufacturers who required professionals to adhere to strict standards when collecting vital data to be used in managing the disease (Juusola, Brandeau, Owens & Bendavid,

In order for a pharmaceutical company to gain FDA approval for a drug, the company

Another question we come across in this case is "Should these pharmaceutical companies have a moral obligation to make the drugs available to the people who they performed clinical trials on?". Again we clearly should see that the pharmaceutical companies should allow the access of these drugs to the people that are being used to test their products. There is a huge risk for these people who are taking a new drug, not knowing exactly what the outcome can be and are merely treated as guinea pigs for the

.Almost 25 millions Americans are suffering from different kinds of rare disease. This number is smaller as compared to the overall population of USA but FDA has approved one third of the products for rare disease patients since last five years. FDA is approving some non traditional drugs for these rare diseases for example Kalydeco (ivacaftor that treats patients with cystic fibrosis. Almost 30000 people are affected by cystic fibrosis and it’s a disease of gene mutation. This disease also effects other parts of the body like lungs and liver. It slows down respiratory, digestive and metabolic process and causes an increase in weight gain . FDA designate Ivacaftor a priority review and is approved before the target time, in less than 6 months. It is a great achievement of FDA as Ivacaftor is the first drug to treat symptoms and complications associated with cystic fibrosis.(Hamburg,

The current regulations governed by the FDA are very strict and should remain that way because the base of these regulations are underlined by various tragedies which we don’t want to be repeated. For instance, the thalidomide incident in which many children were born with Phocomelia (shortening or absence of limbs). Thalidomide, which started as an OTC drug in 1957 as a remedy for sleeplessness was later found to have off-label effects such as mitigation of morning sickness in pregnant women. Hence was then prescribed worldwide to pregnant women. However, in 1962 Frances Kelsey prevented the approval of this drug in the USA. This resulted in Harris-Kefauver Amendment in 1962 which tightened the investigation and approval of drugs requiring the manufacturers to prove their safety and efficacy. Many incidents could be avoided in the past if the regulations were firm and so there is an utter necessity of governing bodies for oversight of clinical trials, new drug development and manufacturing of drugs, biologics and medical devices.

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.

UK: In the UK, the early access medicine scheme introduced in the year 2014 for the purpose of allowing patients who suffer from life threatening or serious worsening medical conditions to access the medicines that did not get yet a marketing authorization. An application of Promising Innovative Medicines (PIM) to the MHRA (Medicines