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Safety or Speed in Drug Development?

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Introduction

Since the passing of the FDA Amendments Act of 2007 (FDAAA), there has been an increase in the requirements for safety measures for drugs before they are sent into the market. According to Wechsler (2009), the new Act added new regulations that were to be used in the assessment of risks and Mitigation Strategies (REMS). The Act demanded that there was to be no extension in the review times of the drugs and to counter this problem, electronic submissions were to be used. However, these processes have continued to increase the time taken for drug development because the systems are not yet ready. Drugs therefore take very long to get into the market.

Once the drug developer complete his work and submits it to the US Food and Drug Administration, it is upon FDA to ensure that the process to approve the drug and allow its usage is made quick to allow the use of the drug to cure or prevent diseases and conditions (Wechsler, 2009). The problem is; can the time taken to approve the drug be traded off with the safety of the drug? Or should it be the other way? If drug development takes such long periods as it does today, fewer drugs shall be developed and this would result to a hitch in healthcare improvement. On the other hand, quick development of drugs and entry into the market could lead to the entry of bad drugs that could have dire consequences after use. In my opinion, safety should be the more important issue to address ahead of safety. In my opinion, safety should never be traded off for anything. The main aim of developing a drug is to cure, prevent or both and when these roles are compromised, the whole medical discipline would not be as effective as it should be (Wechsler, 2009). This would eventually lead to dire consequences as unsuspecting patients and pharmacists take and issue unfit drugs respectively.

Why Safety is More Important than Speed- Pros and Cons

Recently, CDER launched a Safety First Initiative which led to their increase in Risk Evaluation and Mitigation Strategies (REMS). They increased these regulations by 63 between 2006 and 2008. Among these are the ones stating that pharmacists should provide patients with medication guides before they start using the drugs they bring forward (Stratmann, 2010). There are further 10 measures that improve communication to health care professionals with explained risks of using the products. This is a very important step that would ensure that the drug user does not use drugs that would eventually harm them (Wechsler, 2009). Despite the commendable step, the process of increasing regulations might not have very good impacts. Business people are out to make money and would not be pleased with the whole process due to the increased regulations. In the long run, pharmacy industry could end up losing its status and this would eventually lead to losses of jobs in the respective businesses (DiMasi, Hansen & Grabowski, 2003).

Currently, drug developers are in a fix to determine whether they should wait for the results to determine whether the long process is necessary. They also have the option of going as per the new regulations and continue to submit REMS without being pushed and then fill the NDA. Risk Evaluation and Mitigation Strategies are not pleasant to fill and drug manufacturers are not willing to follow it in cases where it is not necessary (Wechsler, 2009). It is, however, important that drug manufacturers follow the guidelines for now and wait till they are told whether the new REMS will remain or will be scrapped off. The process of making the rules stricter could lead to increase in prices since the existing drugs could know that there are withheld drugs that would give them competition (DiMasi, Hansen & Grabowski, 2003). They could decide to have cartels and increase their prices which would result to a burden being laid on the end consumers.

The only way to remain powerful in any production field is by providing customers with superior products that are more effective than those produced by competitors (Stratmann, 2010). There should be no comparison between products from the United States and other regions with regard to effectiveness and quality. Safety should therefore be upheld at all costs to ensure that the drugs never disappoint whenever they are taken out to the market. However, due to the increase in time taken to approve a drug into the US market, there have emerged new trends that allow fewer innovations to reach the market. This is consequently affecting the country’s drug field and US is slowly falling behind Europe. The approval rate in the first cycle is slowly but very steadily dropping. It has dropped from 70% to only 50% between the year 2000 and 2008 (DiMasi, Hansen & Grabowski, 2003). This could in the long run lead to the lagging of the United States medical field behind the European Industry. If this continued, United Sates would lose its economic grip which would eventually lead to loss of jobs and income from exportation of drugs.

Recommendation

United States should keep their position as among the best drug manufacturers in the world. This fete should be kept through safety and speed of drug release. It is therefore important that the concerned authorities ensure that the correct balance is struck between the time that drugs are released to the public and the safety measures they take. While safety is the key factor that people should keep in mind while developing drugs, it is important to ensure that drug manufacturing industry in the United States remain on top and should not be surpassed by other regions such as Europe. However, American Drugs should always enter the market with the correct magnitude and precision that they are taken up and take over the market due to their effectiveness. If this is not achieved, there would be a problem in the US drug industry.

Finally, the system of checking the safety of drugs should be streamlined and all barriers that can be eliminated excluded.  More investments on tools and technologies to quicken the process of Risk evaluation and the measures of mitigation should be made to ensure that the process continues more smoothly without trading off the safety aspects. A safe drug development should never be traded off for speedy production.

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