Pharmaceutical Business Case Solution And Analysis, HBR Case Study Solution & Analysis of Harvard Case Studies

Pharmaceutical Business Case Solution

The FDA also assists the researchers in determining the design for the large scale studies of Phase 3. Afterwards, the FDA reviews the IND submission by the researchers. The reviewing team at FDA has a total of 30 days for reviewing the IND submission. This process has an objective to protect the volunteers of the study from the potential side effects and the risks associated with the clinical trials. The FDA responds to these application in two ways: either by suggesting the researchers to start conducting or stop conducting the clinical research. The FDA can also place a clinical hold over the research for the following reasons:

If the participants are faced with significant risks or harm by the drug implications; the FDA has an authority to stop or hold the drug’s clinical research.
If the investigators are not qualified under the personnel regulations by the FDA, then the study will be kept on hold.
The FDA can also impose a hold over the clinical research if the materials used for the participation of the volunteers are misleading.
If the IND application does not possess all the required details about conducting the clinical trials, then the tests will also be stopped by the FDA.

However, there are rare chances of a hold by FDA, the administration rather provides guidelines for improving the quality of the clinical research,but in most of the cases; if the FDA gets satisfied with the quality standards used in the study then it allows the researchers to proceed with the study. The researcher are required to inform the FDA about any changes made in the study protocol as the potential side effects observed during the clinical trial. The goal of this step is to ensure that the researching team monitors the trials carefully for any significant risks associated with the drug’s application. After getting done with the trials; the researchers are required to submit their study reports to the FDA.

Marketing Approval

This a stage where the drug is reviewed by the FDA in order to approve it for marketing. If a researcher is able to present all of the evidences form the pre-clinical and clinical studies about safe and effective usage of the drug, then the testing team can file an application with the Food & Drug Administration to market the drug. The application which can be filed is known as NDA, i.e. New Drug Application, which must specify all of the information related to safety and intended usage of the drug. The drug developers are required to include information from aforementioned phases in NDA. Along with the results coming from clinical testing; the researchers must include information related to the safety, patent, directions for the drug usage, labeling format, drug abuse and data related to the experiments conducted outside the United States.

After receiving the NDA; the Food & Drug Administration checks whether the information provided is complete or not. If the NDA is not complete, then FDA will refuse to file the New Drug Application, if they find it complete, then they have 6-10 months on deciding over the approval or disapproval of the drug. During the approval process, each member at the FDA review team, accesses his assigned section of the application. For instance, the pharmacist reviews the animal testing data, the medical officer examines the clinical data etc.

The FDA inspectors also go for a routine inspection of the clinical testing site in order to determine the manipulation, fabrication or data withholding by the drug developers. Afterwards, an action package is prepared by the project manager, which serves as the record over the drug for FDA. The review team makes recommendations about the drug and a senior FDA officer makes the decision regarding the approval for marketing the drug.

If the FDA review team approves the drug to be effective and safe for usage, then it works with the applicant to develop and review the prescribed information, also known as the product la belling, which specifies the basis for the drug approval and the best usage of the drug. Sometimes, the FDA is not satisfied with the information and it can ask the developers to provide more information or conduct further additional studies. The developer has the authority to confirm with the FDA’s decision, and if he disagrees, then the developer can opt for formal appeals. Apart from this, in order to gain more information; the Food & Drug Administration may organize Advisory Committee in order to gain an expert’s advice or an independent information, whereby it allows the public to make comments about the drug’s effective s and safety.

Post Marketing Approval

At the time, it is impossible to have the complete information related to drug’s approval, even after the pre-clinical and the clinical studies provided effectiveness information and the drug usage;the limitations still exist after having the rigorous steps followed in the drug development. The true results about the drug and its effectiveness come after a longer period of time, i.e. it almost takes months or years to become a lifetime drug in the market. The Food & Drug Administration reviews the problems related to OTC (Over-the-counter) and drug’s prescriptions.

The drug developers need to file a supplemental application with the FDA, in order to make certain changes in the drug or the NDA. The changes related to the labeling, dosage and the formulation must be approved by the FDA. Moreover, if the drug’s sponsors want to deploy the approved drug for another usage, new form, or new strength; they must do so under the requirement of INDs.

In addition, the FDA officers pay routine visits and carry out inspection of the drug manufacturing facilities throughout the whole United States and other foreign countries. The inspection can be unannounced or they might be informed to the developers in the advance. The inspection can either be made for routine checks or they may be done over the reported issues. The main objective behind such inspection is to ensure the good practices followed by the manufactures in developing drugs. The FDA holds the authority to shut down a manufacturing facility, if the product’s standards are not followed properly.

The regulations are made for the drug advertisements also, i.e. the FDA is responsible for the regulation of the drug advertisements, prescriptions, and promotions and labelling. It is regulated that the reminder ads, product claims and all of the advertisements must not be misleading and they must reveal the true information. The true information related to the drug usage, its side-effects and prescription must be revealed by the drug’s developers.

After getting approval for marketing, it is mandatory for the drugs’ developers to get the drug’s patent, which gives the right for marketing the drug exclusively to the drug developer. After the expiration of the drug’s patent; the drug can be manufactured by other drug manufactures, which will be referred to as the generic version of the drug. The generic drug can be produced under different brand names, but it must contain the same quality, safety, performance characteristics, dosage and the intended usage. The generic drug manufacturers are not required to conduct clinical testing as these drugs are similar to the drugs already present in the market, rather, they are required to conduct the bio-equivalence studies and file an abbreviated NDA.

Foe reporting the problems associated with the approved drugs; the Food & Drug Administration has developed several programs such as: Med-watch and Med-Sun. The Med Sun refers to “Medical Product Safety Network”, which examines the effectiveness and safety of the medical devices throughout the entire United States.The FDA appoints 350 health care providers, who are responsible for dealing with the medical device problems, which tend to lead towards serious injury or death. The FDA issues a newsletter each month, where it provides the medial device safety information to the consumers.

Similarly in the European Union, all of the marketed medical devices must contain a CE (Conformite Europeene), which ensures that the medical devices are manufactured in compliance with the EC Medical Device Directives of the European Union. The medical device, which contains a CE mark, can be marketed in all of the states of the European Union members. If the medical devices are with low risk and implantable, then these are self-marked as A CE device by the manufacturer, but if the device presents a high risk then it is reviewed under the extensive review by the European Union authorities.

PART B

1.Pharmaco-vigilance

Pharma co-vigilance is the process of drug safety that is used after the licensing process of the drug. It is the process that contains assessment,prevention and controlling of drugs from any hostile effects.The regulations and principles are implemented by WHO for organizations.The. prime goal of pharma co-vigilance is to ensure that the products must be used for safe perspective.It is the process that eliminates the risk and increases the positive results of the product.

In the 21^st century, new regulations are implemented in the pharmaceutical industry, which are of two types: one is related to process and another is the use of medicines for the safety and health perspective. The main use of pharma co-vigilance described by one the types of research that it should decrease the harmful elements and expand the knowledge and safety. Expend of the information implies how long will it take to cure the patient and its reactions.This information process is done through an integrated system which contains the elements of activeness, systematic and information collection............................

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