Custom «Pharmaceutical Law» Essay Paper
The current is looking for a cure or the closest thing that resembles a cure for a given disease. Although each of the drugs identified is promising, the weights are not equal. The drug patented in 1995 is the most promising one as it reduces death in subjects (mice) by the highest percentage (85%). It also reduces HgA1C by 2% which is almost the average reduction of the three drugs put together. One advantage is that it is more promising than the other hence presenting greater success rate chances. An additional advantage is that it will deduct the cost as efforts needed to progress are lesser than in the other drugs. The evident risk is that the drug patented in 1990 might be more effective the 1995 drug. This is because it has a significantly higher mortality rate reduction in mice and reduces HgA1C 1% better than the 1995 drug. The other risks are inherent to all other drugs. Its effect on mice may not resemble its effect on people.
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One of the challenges is related to identifying the effect on treatment. Phase III suggests that the researchers identify the effect of the drug in both animals and people. It also reveals the length of the effects. Identifying these effects on people is one challenge as the researchers have to find voluneers who will take part in the trial process (Arcangelo & Peterson, 2005). The other challenge is related to finances. This phase incurs the most cost. The pharmaceutical company needs many funds to carry out this stage successfully, which may not be at the company’s disposal. The company can overcome the first company by compiling the relevant data that will challenge a patient to take part in the research. This will begin by progressing with the drug that is most promising. The other challenge can be overcome by targeting donors (Arcangelo & Peterson, 2005). Donors will only be willing to put their donations in a drug that is promising. The relevant data in the previous stages should therefore be carefully gathered.
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One of the strategies of increasing the commercial lifecycle of the drug is by making new formulations (Gupta, Kumar, Roy, & Gaud, 2010). This will integrate having additional patents that cater for new formulations of the identified compound. The other strategy relates to making combinations. In such cases a company combines two or more drugs that are already a success in the market, thus marketing them as one product (Gupta et al., 2010).
One of the post-marketing obligations includes accurately reportting any issues identified in the market to the relevant authorities. Another obligation is related to recalling the drug from the market if it is identified as harmful to the patients (in a larger population). The company can make relevant modifications in relation to the issue identified, which is costly. They may also be forced to totally eliminate the drug from the market, which is more expensive (Friedman, Furberg, & DeMets, 2010).
According to the New Drug Application of FDA, the company can be held on criminal charges if they withhold any relevant information regarding the drug. They would also be negligent if they release a faulty drug in the market or continue to sell a drug after realising its faults (Gupta et al., 2010). They can be sued by the affected persons.
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The company can be faced by both criminal and civil cases. If it acts in negligence, it is liable and can be sued by the affected parties. If it hides relevant information to the relevant authorities, which would risk the lives of the patients using the drug, it would be criminally liable. The company can avoid the same by revealing all the information available and recalling the drug from the market after identifying certain faults (Friedman et al., 2010).
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