FDA and Drugs Questions and Answers

People around the globe use various medications without knowing the reactions they will have on their bodies. They don't know if the drugs will have adverse effects, even death, to their bodies, or if they will make their sickly situations better. However, the Food and Drug Administration (FDA) takes the initiative to decide on the best forms of medication on behalf of billions of people on earth. The effects of this medications rely on FDA, and hence they have to be very keen on such decision making. This essay aims at analyzing whether drug industries know the type of mistake that drug firms can make. It also elaborates on the possibility of a drug industry composed of few but large firms to make less or more errors as opposed to a drug industry consisting of many smaller and competitive firms. Also, the essay describes the advantages and disadvantages of a drug regulatory plan that prefers the FDA setting its thoughts on the safety and side effects of a drug to give free will for physicians to prescribe or avoid it, to the FDA making the final choice of disqualifying or permitting the drug.

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Q 3. Does the structure of the drug industry have any bearing on the types of errors that drug firms are likely to make? That is, would a drug industry made up of numerous highly competitive firms be more or less likely to introduce unsafe drugs than an industry consisting of a few large firms?

Yes, have knowledge on the mistakes they expect drug companies to make. Drug companies are numerous and widely spread around the globe. However, the medication they prescribe to people have to get accepted and passed by the FDA. Every drug made by a particular company has to take close to 10 years before approval, which is a long while for a company to wait only to present a fake drug. The FDA takes its time to analyze the safety of any drug, examining every single possibility of a drug turning out to be fake. However, the process is very costly and can take some companies sometime before they afford the procedure set by FDA to release a drug that could save a lot of people. Drug industries also now that the drug manufacturers can lead to death to several or some people before the medicine gets well-adjusted to a safe and life-saving the form (Mullard, 2015).

The lab testing are never sure, until the side effects of a drug show up in different people, some dying and others developing life defects that can't be reversed. This is the biggest mistake that the FDA cannot evade, since it is counted as part of the sacrifice that comes with introduction of new drugs to counter the many new sicknesses wiping more people on the planet. However, the death cost caused by a new drug cannot make the FDA burn the introduction of other new drugs to the communities because the more people would perish if new drugs don't get established regarding the emergence of new, incurable and complicated illnesses (Mullard, 2015).

A drug industry made up of many highly competitive companies is likely to make less mistakes when manufacturing new drugs. This is because their high level of competition makes every single firm dig deep in research and science to come up with safest and cost-effective medication to the market. Competition is one thing that pushes an institution to produce the best drugs. Such firms work hard to reduce number of people who have to die or have adverse side effects of a drug during the introduction and testing period of a drug.

Also, many drug firms ensure that there is extensive research on a particular disease, exhausting all the options possible towards treatment of one drug. Such research helps in ensuring that a single sickness have variety of treatments depending on the different reactions people have on drugs. Before pharmacist prescribes a certain medication to a patient, they consider their situation from various view, considering any allergies, genetic attachment or the effects of other sicknesses they might have. Coming up with a wide range of medication takes many firms, focused on solving the issue at their best (Vedula & Dickersin, 2013).

However, few drug institutions in the drug industry may get reluctant in manufacturing of medicine with the pace that illness are advancing. Such reluctance would cost the world more lives. Due to low competition, few drug firms might result in introducing unsafe drugs to the community. The FDA won't have much choice to consider when in need of accepting a new drug to get release to the people, especially when the disease is killing people at a fast rate. These drugs might end up causing more trouble than before it got released. Although it takes a while to find a cure for new diseases, it is better to have many firms working on the same issue to generate the best and safer medications to curb the problem in a shorter period (Naidu, 2013).

Q 5. What would be the advantage and disadvantages of a regulatory system in which rather than having the FDA permit or prohibit new drugs, the FDA merely published its opinions about the safety and efficacy of drugs and then allowed physicians to make their own decisions about whether or not to prescribe the drugs for their patient?

There are a couple of advantage attached to the FDA giving the mandate of prescribing a drug to the drug firms instead of declaring the drug bad or good. However, having such power can cause some firms to make more mistakes leading to more deaths.

Advantages

Patients react differently to drugs. Therefore, the adverse effects noted in several patients using one drug would not be observed on other sic people who give positive feedback on the same drug. Consequently, it is an advantage to people if physicians get to prescribe a specific drug depending on previous statistics on the effect of a certain drug. However, for sensitive drugs, the physicians have to conduct an in-study on the patient before risking their lives. It also helps save people's lives in situations where no other treatment can help the patient, but the option to take a risk with the drug. Some sicknesses have no treatment, and the patients opt to try anything in place upon learning the side effects of the drug, and the possibility of them getting better on the same drug (Kalies Jr, 2013).

A firm is held responsible for any side effects or death that arise from the drugs it makes and prescribes to people even after reading the view of FDA about the drug. If the FDA acknowledges that the drug can cause death at some cases or adverse health complications, then in case of any patient said to die or develop vital health issues to that specific drug, the drug firm takes the blame and may end up getting closed and denied from any form of drug supply. It would make drug companies very keen before allowing any medication to the public. Anyone likes protecting the name of its company, and hence it would increase the possibility of supplying a life that has fewer effects and helps solve the health problem (Gupta & Nayak, 2014).

Another advantage is that drug firms get the ability to develop their drug after knowing the defects it might have on human beings. Once the FDA refuses a drug, it cannot get accepted back to the industry. However, once companies the chance to choose whether to release a drug or not, it gives the company the opportunity to improve on the flaws of the drug, ensuring that it does not hurt people (Carpenter, 2014).

There is never any certainty of what a drug would cause if released, or what it wouldn't have done. The FDA may disqualify a drug that would have saved millions of people, or pass a drug that can lead to tremendous deaths. However, the drug firs understand their calculations and estimations on a certain drug better than any other company. Therefore, getting the opportunity to decide the drug to give to patients would ensure that the best choice is made during such dilemmatic periods (Carpenter, 2014).

The FDA can be wrong when deciding which medication to allow or prohibit because of it a smaller institution when compared to a large number of drug companies around the globe. However, it is easier to combine the opinion of FDA about a drug with the thoughts of drug manufacturers to make a concrete decision on the effects of releasing the drug. The aim of a drug is always to make people feel better without creating another health complication. The firms can find another drug to accompany the drug in question to minimize the effects that render the specific drug harmful by the FDA. The manufacturers who come up with the idea of a drug have better chances of improving it or rendering it unfit for use (Carpenter, 2014).

Disadvantages

Some physicians might get driven the high cost of a drug and sell it without putting the patient's situation before anything. The universe has many people who care for themselves more than the lives of others. The drive for money can result in the death of many innocent lives. Therefore, it is better for the FDA to cancel out such drugs, than to entrust it to people who might intentionally hurt people with the drugs to earn an extra penny. Otherwise, there could be lots of suffering, pain, and deaths registered due to a particular drug (Vedula & Dickersin, 2013).

Moreover, some physicians might take advantage of partially working medication to keep their customers coming back for more. Some medication might only reduce the effects of a disease but not entirely eradicate the disease. Also, some medication can be very addictive to patients, which might make them purchase more of the medication to help submerge the pain as they feel the stimulant effects of the drug. In the process, many hospitals have had people who die because the medication prescribed was never working, while their relatives are left to pay huge amounts of the health bill (Gupta & Nayak, 2014).

Conclusion

In conclusion, medication is a sensitive area because it decides on which lives get lost or which get saved. Therefore, the FDA should make agreements with the drug companies to reduce the suffering and deaths associated with inappropriate drugs and promote positive drug effects. It is possible to make an association where the FDA and the Drug firms have to make similar conclusions about a drug before they decide to release it for legal medical use.

References

Carpenter, D. (2014). Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton University Press.

Gupta, S. K., & Nayak, R. P. (2014). Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities. Journal of pharmacology & pharmacotherapeutics, 5(2), 88.

Kalies Jr, R. F. (2013). U.S. Patent No. 8,346,571. Washington, DC: U.S. Patent and Trademark Office.

Mullard, A. (2015). 2014 FDA drug approvals.

Naidu, R. P. (2013). Causality assessment: A brief insight into practices in the pharmaceutical industry. Perspectives in clinical research, 4(4), 233.

Vedula, S. S., Li, T., & Dickersin, K. (2013). Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS medicine, 10(1), e1001378.