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The Pros and Cons of FDA Regulations & Issues in Health Care

This report is multidimensional and examines and addresses the following:

~The pros and cons of the FDA approval system.

~Some strategies to bring about changes in health-care delivery besides legislation and how they could help or hurt the current system.

~Preventive and catastrophic care: should have separate funding sources? why or why not?

~If individuals who choose negative health behaviors should pay higher premiums: Why or why not?

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The Complexities of the FDA

This is a list of some pros and five cons of the FDA approval system and rationale.


1.As a result of heightened FDA vigilance, physicians are now more careful/cautious in prescribing drugs that are potentially very dangerous based on their side effects (They will forever be reminded of Anna-Nicole Smith, Michael Jackson and so many others).

2.Stronger credibility and better reputation for the FDA for truly being a "gate keeper" or "watch dog' for consumers.

3.Increased public awareness and education regarding the dangers and misuse, addictive properties, suicidal tendencies, and general overprescribing of drugs. (I.e. Adderall, Oxycontin, Diazepam, Lipitor, Wellbutrin, Avandia and so many others).

4.In way, the public holds the FDA at a very high standard of disclosure and expect and is fairly confident they will be taken care of, and expects continuous updates on any new happenings with pharmaceuticals. As well they expect to receive (if and/or when applicable) and be made aware through bulletins and on the FDA site etc.

5.Overall safety for the public, less overprescribing, making especially narcotic drugs less accessible-mean doctors will be held accountable for overprescribing. When the laws are enforced most will not practice the way they use to knowing their license and livelihood are on the line.

A closer look at the need for public awareness on prescription drugs(esp. narcotics):

The FDA should not be complacent; rather they should be vigilante in enforcing their regulations. For example, while companies wait for final research results and approval, it would make sense for the FDA to monitor the drug companies every moves. More specifically, the FDA should limit the amount of money the companies spend on advertising such prescription drug ads during the trial and wait phase, and even work with the drug companies to create such prescription drug ads? Why should they not get approval for how they present information to consumers? This could fix many of the problems.


1.Many believe the FDA is trying to 'make examples' out of drug companies and will stop at nothing to start an investigation. In essence, much of it is unnecessary.

2.Although the FDA has cut back considerably on their approval time, (27 months-14 months). It needs to continue to work on even shorter (and even safer) approval times. Too many people die during the interim-as was the case with Vioxx (almost 200, 000) patients died from heart attacks) (FDA, 2012).

3.Unless the laws are enforced and guidelines for adherence are even stricter, many still re-offend. Unfortunately, corruption is also involved in many aspects of the process. Often times, bribes are used to cover up stories, offenses, and to prevent people from 'squealing' so to speak.

4.Similar to using the internet for medical information Patients and the public in general while they like to be updated on the latest, panic and blow everything out of proportion, as soon as it is known a drug is under review. They panic to the point of stopping their medications without consulting their physicians (depending on the condition-this action could be even more dangerous).

5.Drug companies are allowed to distribute drugs in the meantime they are waiting for final approval. Greed and corruption allow people to only think in a monetary sense, rather than about each other.

Prescription Drugs and the FDA

Although they save lives, the ongoing wariness and suspicion of prescription drugs is fast becoming a trend, both in how they are prescribed and overprescribed, as well as how they are marketed to consumers. Using the case of Merck once more, if they had waited and completed the research before placing the drug Vioxx on the market, the outcome would have been very different. Although the FDA gave Merck its approval for the drug, the FDA itself was not clear and very certain about the drug. This uncertainty and doubt should have been enough to make a decision to halt placing the drug on the market and eventually to patients.

Merck and the FDA even if they felt safe with the drug's main use (FDA, 2012), one has to be careful when combining drugs or using certain drugs based on pre-existing ...

Solution Summary

It is critical that the FDA strengthen and refine its current system of reviews, research protocols, and oversight procedures, so they can deter and detect similar conduct in the future. Concern, wariness and suspicion of prescription drugs is fast becoming a trend, both in how they are prescribed and overprescribed, as well as how they are marketed to consumers. Any type of uncertainty and doubt should be enough to make a decision to halt placing drugs on the market and eventually to patients. Thorough rather than partial research should be done and completed before placing a drug on the market.