Brice's policy paper

Policy Paper
Background
In today’s society, “antibiotic resistance has been called one of the world’s most pressing public health problems “(1). Ones reliance on drugs whenever they have an illness, especially when the drug will not work for that bacterium, is contributing to this problem. The consequences when antibiotics fail to work may be long-lasting and can result in more expensive prescribed drugs to kill the bacteria (1). The more a person takes antibiotic drugs, the more the bacteria may become exposed to that drug more and the greater the amount of chances that one of the bacteria may survive. The one bacterium that survived now has the ability to multiply and replace all the other bacteria that were killed off (2). These bacteria can mutate and over time become resistant to the antibiotic that it was once susceptible to.
Evidence has shown that this problem of bacteria resistance is starting to occur. In one case, vancomycin was taken to fight off the bacteria known as staphylococcus aurenus, but research has shown that there are strains of vancomycin-resistant S. aurenus already beginning to emerge (3). These results may have many people questioning how long it will be until S. aurenus may become resistant to other antibiotics. Another case where people may be worried about antibiotic resistant is in commonly used drug called penicillin. Recent research has found a rise in the number of penicillin-resistant strains of S. pneumonia (3). If a well-known trusted antibiotic, such as penicillin, can have resistant bacteria to it, there is a good chance other drugs will soon follow. There are some bacteria that are found to be resistant to all commonly used drugs, such as Pseudomonas aeruginosa and Acinetobacter baumanii (3). These bacteria prove that it is possible for bacteria to become resistant to certain antibiotics and it is only a matter of time before more cases appear. Based on this information and many concerns about the well-being of Americans in the future, the FDA is has approve a new policy that will go into effect on January 1, 2009. The policy is to shorten the length of drug patents and provide incentives to pharmaceutical companies to develop new antibiotics. The FDA believes that by establishing this policy, companies will produce new antibiotics quicker than in the past in order to help reduce the number of bacteria that are becoming resistant to commonly used antibiotics. New antibiotics can help reduce antibiotic resistant by exposing the bacteria to other antibiotics that they are unfamiliar with and reduce the chance of bacteria mutating to previous drugs that they have been exposed to for many years. The new antibiotics may be more effective in fighting off the bacteria and the strains of bacteria that are proven to resistant to other drugs. This policy is needed in today’s society because of the overuse of antibiotic drugs by people. Without this policy in effect, bacteria will have a greater chance of becoming immune to antibiotics and antibiotic resistance will continue to increase in the future.

Policy
A. The major change in this policy is the patent life for a drug manufacturer. The original policy had a patent life of twenty years that was established in 1995 by the Uruguary Rounds Agreement Act (4). The FDA will decrease the number of years a company can obtain a patent from twenty to ten. The ten years start from the moment the drug company applies for a patent.
B. The Patent Trademark Office will only be allowing patent extension on the drug every two years if the company can show significant progress in the manufacture of a new drug. However, the patent cannot exceed sixteen years unless the company has manufactured a new drug. The FDA will analyze the new drug and if it meets FDA guideless and is an effective drug, the patent can be extended to the full twenty years. All six steps in the process of getting a patent extension set by the FDA must be met in order to grant a patent extension (4).
C. If the FDA feels like there is a stall in process between the tenth and sixteenth year of the patent, they may revoke the patent extensions and the drug will no longer belong to the manufacture. Manufacturing companies must submit a report to the FDA every year of the new drug being manufactured between the tenth and sixteenth year. Any manufacturer that does not submit this report will have their patent of the previous drug development revoke immediately.
D. These guidelines apply to every patent a company may have. If I company has five drugs on patent, it must show the progress of five new drugs being created. There will be no funding supplied.
Conclusions
Some individuals and pharmaceutical companies may not agree with the new policy being enforced by the FDA. These people may argue that is costs too much and takes too long to get a drug approved by the FDA and therefore this policy would make pharmaceutical companies have less profits and there will not be many drugs produced in years to come because of high cost. They would argue that is costs an estimated 868 million dollars and takes between ten to fifteen years to get the drug researched and approved by FDA (3, 5). The FDA’s response to this argument is that the companies will not lose money as long as they are showing progress in making other antibiotics and they can still get the full patent length and will not lost much money at all. After the ten to fifteen years of getting a drug approved, the manufacturer is making profits on that antibiotic drug and they have no need to start the process of making a new drug until they patent is expired. This policy makes manufacturers start to produce new antibiotics at about the same time they start making money on the drug previously produced. The cost of the new antibiotic being developed can come from the large profit companies are making after the drug goes on the market. The FDA hopes to have a continuous process of antibiotics under research and approval through this policy.
The other main argument about this policy would be whether this will have any effect on antibiotic resistance. Many will question if this policy is worth the time and can solve the problem of antibiotic resistance because it takes so long to produce a new drug. This policy will not have a short term affect on antibiotic resistance but in decades to come it will contribute greatly. The larger access of antibiotics that are available to people will reduce the reliance on one commonly used antibiotic and reduce the chance of bacteria to mutate and evolve to become resistance to antibiotics. This large variety of antibiotics will allow doctors to have different choices as to what antibiotic to give a patient and will not have to give the same antibiotic over and over again. Bacteria have been around for millions of years and humans come nowhere close to this length. In order for bacteria to have lived this long they must have evolved and it is only a matter of time before they are resistant to already produced antibiotics. This speculation is one of the many reasons the FDA is making a new policy to help fight antibiotic resistance and without this policy bacteria may become a greater health risk in years to come.

References
1) National Center for Immunization and Respiratory Diseases/Division of Bacterial Diseases, “Get Smart: What Everyone Should Know and Do With Antibiotics.” About Antibiotic Resistance. 18 August 2008. 9 October 2008. <http://www.cdc.gov/drugresistance/community/know-and-do.htm>.
2) National Center for Immunization and Respiratory Diseases/Division of Bacterial Diseases, “Get Smart:About Antibiotic Resistance, FAQs.” About Antibiotic Resistance. 22 August 2008. 9 October 2008 <http://www.cdc.gov/drugresistance/community/anitbiotic-resistance-faqs.htm#6>
3) Salyers, Abigail A., and Dixie D. Whitt. Revenge of the Microbes. Washington DC: ASM Press, 2005.
4) OTCOM/DLIS. Patent Term Restoration. 12 May 2008. 8 October 2008 <http://www.fda.gov/cder/about/smallbiz/patent_term.htm>.
5) Adams, Christopher P. and Van V. Brantner. “Estimating The Cost Of New Drug Development: Is It Really $802 Million?” Health Affairs. 7 March 2006. 10 October 2008 <http://content.healthaffairs.org/cgi/content/abstract/25/2/420>.

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