Fda Approved Drugs: Do Risks Outweigh Benefits?

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

Product liability laws allow drug users to sue the manufacture, not the FDA, for any adverse drug reactions and side effects. While the FDA oversees drug safety, they do not ensure it. To avoid the costs associated with lawsuits and the risk of a bad name, drug companies do their best to fully, sometimes overly test products before release. “When product liability law attempts to ensure safety already assured by the FDA, prices may be inefficiently high due to liability costs that do not deter manufacturers from producing unsafe products” (Philipson & Sun, 2008, p. 86).

With the growing reliance on medication therapy as the primary intervention for most illnesses, patients receiving medication interventions are exposed to potential harm as well as benefits. Medicines have proven to be very beneficial for treating illness and preventing disease. This success has resulted in a dramatic increase in medication use in recent times. Unfortunately, this increase in use and expansion of the pharmaceutical industry has also brought with it an increase in hazards, error and adverse events associated with medication use.

In the same country where someone dies from accidental prescription drug overdose every 19 minutes, one must ask what is being done by the FDA to stop this. The answer to this is quite simple. Nothing. In the past thirty years, approximately 90% of all the new drugs approved by the FDA have had little to no advantages over existing drugs on the

According to Miller, Benjamin, and North, “FDA bureaucrats decide whether or not new medicines (prescription drugs) should be allowed to go on sale in the United States” (Miller, Benjamin, and North, page 3). Prior to the 1962 Kefauver-Harris Amendments being made to the 1938 Food, Drug, and Cosmetic Act, the FDA was given a limited time frame of 180 days to approve or deny a new drug application. These amendments added a new “proof of efficacy” requirement and removed the 180-day time constraint, allowing the FDA to demand whatever

Great post. I too took away the message from our text that no medication is without risks or side effects, and that is something that is going to stay with me. I believes it becomes easy to forget this notion when one takes a medication and maybe do not experience the severe side effects or even minor side effects. As a result have the person has a sense of false security view of the medication because a medication which may not always be in the case in the future. To me this view of medication applies to both over the counter medication and prescription medicine. I once knew someone who’s daughter was in the ICU because she took too many aspirin and had liver damage as a result. Next, I really like your realistic example of when

The first reason is Many people with cancer have to take these if they want to survive or get better (“Off Label Drugs”). Every other kid gets to live by a single drop of this prescribe drug. 85% of kids survive these conditions (Gulfo 4). That companies have the right to market their products to doctors. FDA announced that there were important public policy reasons for allowing manufactures to disseminate truthful and non-misleading medical journal articles (“Off Label Drugs”). Some doctors who support off label drugs prescribe say that it actually helps when companies that do the work and not doctors ("off label"). The doctors should be the people that save people's life and makes kids great and healthy again, not the people that put drugs on markets that people can

Last year, in September 2004, Merck withdrawed Vioxx, off the market. Studies of Vioxx showed that it doubled the risk of a heart attack or stroke for patients who have used it more than 18 months. After Merck, withdrawed Vioxx from the market, the FDA, issued a public health advisory for the users of Vioxx. Therefore, Vioxx was on the market for five years without

There is a prescription drug for every ailment, and drug corporations know this. That is why there are so many drug ads on television and on the internet. Whether you cannot sleep through the night or are suffering from headaches there is always a pill for you to take and they are advertised in commercials. We are advised to ask our doctors before taking them but many do not do so. Drugs are not like most other products where you can go to the store and grab them from off of the shelf, you need someone's permission to buy drugs. You get the permission from your doctor. When one is prescribed a drug from a trusted physician, they tend to assume it is the most effective or innovative drug available. We like to believe that our doctor would be

Biologics are a recent discovery in the field of medicine. There is still much that is unknown about their long-term side effects. A few biologics have already been taken off the market due to safety concerns while many others have never made it past test stages due to their risks. Raptiva (efalizumab) was pulled off the market in 2009 due to fatal side effects and central nervous system disorders.

months.12 FDA reviews the drugs in 60 days (Fast track) that intended to treat serious or lifethreatening

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

One factor that must be considered is that the drug had not yet been approved by the FDA, but was in phase III trials. Historical data shows that 65% of drugs in this phase eventually get approved for sale to the market. It was felt that approval of the drug would occur late in 1998.

The pharmaceutical industry confronts several dilemmas every year. Most of these dilemmas revolve around money or whether or not to sacrifice now for a bigger payoff in the end concerning money and/or lives. Pharmaceutical companies tend to use shortcuts that create ethical problems. Drug companies have spent millions/billions of dollars in research, and they obviously want to see

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;