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Saturday, July 2, 2011

Generic Drug Policy Paper

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Summary


When you go shopping for groceries, do you buy the generic brand or the brand name product? Most consumers would buy the brand name product because they are the most familiar with that particular product. They are hesitant to buy the generic brand because they think it is not the same product as the brand name. However, would you believe that almost all generic brand products are exactly the same as their brand name equivalence! Of course not, you would not think twice to save two dollars purchasing the CVS brand of Tylenol or purchasing the actual Tylenol. Although both are as safe and effective, most consumers would buy the brand name Tylenol with the red and white label that has helped take care of their aches and pains before. The media is biased towards generic products because they only advertise the brand name products. Therefore, consumers are more likely to purchase the brand name product over the generic equivalence.


As more generic products are reaching the market, it is necessary for consumers to be aware that these products are the same as its brand name equivalence. Especially when it comes to purchasing medication. Consumers can save a lot of money if they purchase the generic drug. Since the elderly are frequently taking medicine, it is best if they use the generic brand because it is more cost efficient. In the past year, the elderly were denied prescription coverage under Medicare. Therefore, forcing them to pay for prescription drugs out of pocket which is very costly. If there were more generic drugs reaching the market more quickly, this group of consumers will be able to afford their medications.


In America, one of the ways we reward innovation is by granting a patent. If you take a risk and you make an investment and succeed, you have the exclusive right to sell what you invent, and you have the right to profit if you can. A new drug can cost as much as $800 million to develop and bring to the market. Without patent protection, few would take such a risk; few would be willing to invest. With patent protection, America’s brand name drug companies have become the greatest in the world, and health care systems around the world depend on American innovations they could possibly duplicate. (Bush )


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Patents do expire after a number of years, and this is one of the ways we are able to make drugs more accessible. After the patent expires, other companies are free to offer the drug in generic form for lower prices. The average brand name drug costs more than $7 per prescription and the average price for generic drugs, which are just as safe and effective as the brand name drugs, is less than $17 per prescription. Generic drugs make American health care far more affordable. (Bush )


With the implementation of a policy, which brings generic drugs faster to the market, consumers will save up to 65% on prescription drug costs. As a result, the policy will limit the brand name manufacturers to a single 0-month stay per drug, which will bring the generic drugs more quickly to the market.


Formulation


The societal problem, which I seek to alleviate through my policy, would be a manufacturer of brand-name drugs keeping cheaper generic versions off the market through devious delaying tactics, which would prevent consumers from buying less expensive drugs. Some of the brand name manufacturers have been extending the effective lives of their patents by tactics that are fraudulent.


Ordinarily manufacturers are granted patents that give them a monopoly for twenty years, which is ample time to recover development costs and make a profit before generic competitors are allowed on the market. However, through loopholes in current law, the companies can get an automatic 0-month extension simply by filing suit against a generic manufacturer. (Ending a Drug Patent Scam 1 & )


The delaying process of generic drugs reaching the market is having a major effect on the elderly consumers. Ever since Congress failed to pass prescription drug coverage through Medicare, they have been forced to pay for their own medication. Drug prices have increased, making their only option but to buy the brand name drugs. Therefore, the need for affordable drugs is a must!!


As stated by President George W. Bush, “Our message to brand name manufacturers is clear, he said. You deserve the fair rewards of their research and development, however, they do not have the right to keep generic drugs off the market for frivolous reasons” (Goldstein ). He wants to make it easier for Americans to buy generic drugs, especially bringing affordable drugs to the seniors.


Through policy, much can be done to bring generic drugs more quickly to the market. I have proposed three policies, which I believe, can help to aid my societal problem. My first policy would prohibit manufacturers of brand name drugs from filing suit against pharmaceutical companies. My second policy would be the United States Government giving the elderly prescription drug coverage. The third policy would be for the United States Government to give discount cards for drug prescriptions. All three policies, if implemented would help to alleviate my societal problem.


Policy one will in turn bring more generic drugs to the market, which will cost less for the elderly to purchase. The policy will make it more difficult for companies that make brand name drugs to get repeated delays when manufacturers of generic drugs challenge their patents in order to reach the market. Brand name drug manufacturers sometimes file lawsuits against generic drug makers poised to put less expensive competitors on the shelves. (Goldstein )


Big pharmaceutical companies are increasingly using this tactic to fend off competition and keep generics out of consumers’ hands, sometimes for years. Is this fair? Usually there is no such patent challenge, but in some instances the brand name makers use the 0-month shield more than once. If we limit the brand name manufacturers to a single 0-month stay per drug, then more generic drugs will reach the market faster. (Lindlaw 1&)


Policy two will allow for prescription drug coverage for the senior citizens. If the government gives the elderly prescription drug coverage they will be able to afford these brand name drugs. Due to the fact generic drugs are not reaching the market fast enough; these consumers are forced to buy the brand name equivalence. In addition, brand name drugs can cost more than $7.00 per prescription where as generic drugs cost less than $17.00 per prescription. The brand name drugs are 65% more costly. However, if they were given prescription coverage, they would not have to worry about these out of pocket costs.


The third policy will be that the government will give the elderly discount cards for drug prescriptions. Again, since the generic drugs are not reaching the market fast enough, they are forced to pay for their drugs on their own. If the government gives them a 50% discount on the brand name drugs, it will be more cost efficient for the elderly. These particular groups of consumers purchase drugs more often then other groups; therefore, they should receive some kind of discount if a generic equivalence is not available.


Implementation


Which policy will likely to be implemented? Policy one is the best plan that should be implemented. In July of 00, the senate passed the Greater Access to Affordable Pharmaceuticals Act, which will change drug patent laws to speed the market entry of generic drug prescriptions. President Bush announced that the administration would move to limit the brand name manufacturers to a single 0-month stay per drug. As a result, more generic companies will able to put their drugs on to the shelves and into the hands of consumers.


President George W. Bush was a key player for this policy. Although Congress must agree with this policy, President Bush was really the key person to implement the policy. He stated, that the proposal “is another advance in the cause of bringing affordable prescription drugs to our seniors” (Goldstein ). In addition, another player was Senator Toricelli (D-NJ) who stated, “that the bill could reduce drug costs by up to 65% and save consumers $60 billion over the next ten years” (Tantono ).


On the other hand, Charles Schumer, a player for this policy was skeptical. He stated, “this sounds like an Election Day conversation, the devil will be in the details. This could be a very good proposal, but given the White House’s track record on this issue, it could be just another loophole to let the name brand drug companies delay the implementation of generic drugs” (Lindlaw ). Although there are some players who oppose this act, it did not stop Congress from passing the Greater Access to Affordable Pharmaceuticals Act on July 1, 00.


Evaluation


The implementation of this policy, Greater Access to Affordable Pharmaceuticals Act in July of 00 will save the government $ billion in drug cost per year because more generic drugs will reach the market more quickly. This legislation will reduce drug costs by up to 65% and save consumers $60 billion over the next ten years. The policy will also provide more generic drugs to the consumers as well as allowing the elderly to afford their medication. In addition, the consumers will be able to purchase cheaper drugs, which are just as safe and effective as the brand name equivalence. The bill also would stop drug company abuses that prevent generic competition and lower prices, prevent illegitimate patent and end anticompetitive sweetheart deals between brand name and generic companies. (Bush )


On the other hand, there are very few costs accept for that manufactures may loose money because of generic drug competition. The manufacturers may not want to take the risk of doing R&D to formulate a new drug because of the high chance of pharmaceutical companies selling the generic drug equivalence. In turn, they are able to sell the generic drug for less, which will hurt the manufacturers because their drugs are much more costly. As a result, more consumers will purchase the generic drug due to the fact it is cheaper as well as being safe and effective as its brand name equivalence.


As a result, the benefits do out way the costs! If the policy is aiding to save the consumers money while allowing for a safe and effective drug, then why hesitate to implement this policy?





Works Cited


Bush, George W. “Remarks on Prescription Drugs.” Weekly Compilation of


Presidential Documents 8 October 00.


Goldstein, Amy. “Bush Plan to Increase Generic Drug Draws Flak.”


The Washington Post October 00.


Tantono, Welly, Sharon Selby, Jessica Bagner, and Christine Sonu. “Senate Passes Bill


Amending Drug Patent Laws.” Intellectual Property & Technology Law Journal November 00.


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