Fda Pros And Cons

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

The pharmaceutical industry is one of the most powerful and greedy industries in our country, with a goal to make as large a profit as possible, at the expense of the sick.

The rise in drug prices is causing the public to ask why this is so and why there isn’t anything being done, or what the reason could be for sky high prices. Some of the reasons include pharmaceutical companies setting their drug prices

According to the Food and Drug Administration (FDA) they are in operation to help protect public health, primarily by ensuring that companies prove the safety and efficacy of drugs/devices, manufacture them properly, and market them appropriately. Almost every investor has probably heard stories of the traveling medicine shows of the 1800s and early 1900s where frauds sold various "patent medicines" that, did not cure anything and at worst were actually quite harmful. (Stephen D. Simpson, 2014)

In 2015, the pharmaceutical industry spent over 27 billion dollars on advertising. The two greatest components of this effort were promotional advertising and free medication sampling, which the pharmaceuticals invested 15.5 and 5.7 billion dollars respectively (“Persuading the Prescribers”). Promotional advertising involves direct contact with health professionals, the most common being extravagant lunch conferences held for physicians and their staff. On the other hand, sampling involves distributing free sample of medications to physicians, who then have a choice of providing these samples to patients. As a result of these methods, the industry has seen revenue around $400 billion with 90% of physicians having a relationship with a drug company (Campbell 2007). Moreover, the prices of prescriptions continue to rise; a copay of a generic drug is $11.72, preferred brand drug is $36.37 and a specialty drug is $58.37 (Coleman and Geneson 2014). Although the profits are immense in the numbers demonstrated above, it is no surprise when pharmaceutical drug companies elevate their prices even more. For instance, recently Turing Pharmaceuticals raised the price of their medication Daraprim from $13.50 to $750. Keep in mind, this medication is used for threatening parasitic infections, aids, and cancer with alternative options currently found to be inefficient (Pollack 2015). Another example of this practice involves cycloserine, a drug used to

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

The FDA has lowered drug approval standards, pharmaceutical companies have ensured that the FDA will be compensated for approving these medicines. The Pharmaceutical campaigning led to the Prescription Drug User Fee Act (PDUFA) of 1992 and it was reauthorized in 1997. This allows the FDA to collect fees from pharmaceutical companies to review new

One of the underlying issues of rising costs lies in the hands-off role that the government is given in regards to the price-setting of drugs offered through prescription drug plans (PDPs). The Medicare Prescription Drug Improvement, and Modernization Act (MMA) of 2003 is the essential piece of legislation that created what Medicare Part D provisions (Frank & Newhouse, 2008) are in place currently. While this provision provides low-income older Americans with necessary medications, within the initial bill, the governmental program suffers a loss of autonomy. Under this bill, the government is barred from engaging in negotiations with pharmaceutical companies through the “noninterference” clause (Cubanski and Neuman, 2015). This prohibition

The rise in costs of prescription medicines affects all sectors of the health care industry, including private insurers, public programs, and patients. Spending on prescription drugs continues to be an important health care concern, particularly in light of rising pharmaceutical costs, the aging population, and increased use of costly specialty drugs. In recent history, increases in prescription drug costs have outpaced other categories of health care spending, rising rapidly throughout the latter half of the 1990s and early 2000s. (Kaiseredu.org, 2012).

As the business practices of the pharmaceutical industry become more public, formal complaints can be logged that will forces politician to take notice in order to appease the concerns of their constituents. For instance, Senator Bernie Sanders (D-Vt) is a public supporter for the California Drug Price Relief act, (also known as proposition 61) written by Michael Weinstein and was on the California’s November ballot. This act identified that prescription drugs are the main reason for Californians increasing cost for healthcare. This act, if approved, would require negations with drug companies to set medication prices to be equivalent to the amounts paid for the same medications by the United States Department of Veterans Affairs. The DAV is

What some viewed as “overregulation” was criticized for being “unnecessarily cautious and bureaucratic” and there was an increasingly pertinent pressure from the industry and economic conservatives to speed up the new drug review process. Some research showed that throughout this era of regulation, the typical new drug took more than 12 years from initial synthesis to FDA approval and that the FDA review process by itself took 2.6 years. However, because public interest and opinion continued to align with the idea that the FDA should aim to prevent the sale of unsafe or ineffective drugs in the U.S. in hopes to avoid Type I errors in drug approval, the agency was not immediately responsive to this pressure. This alignment, however, shifted in response to the AIDS epidemic and the activism that came with

. The FDA notes a long list in the article of what they are used for:

Back in 2007 the FDA ruled that the bottles needed to have black box warning label on them, but since that time more evidence questioning its safety have emerged forcing the FDA to revisit the issue. Of course prescription drugs are not the only option for some diabetics. New technologies continue to come out making life easier on diabetes suffers. Diabetics used to have to go to a lag every few months, the wait days to get their results. Then technology made it possible to glucose testing at home with stripes. Then came along long insulin pens that replaced the need to inject insulin with a needle.

comprehensive regulatory framework. In the United States, the Food and Drug Administration demands to test

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.