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How Generic Drugs Affect on US Consumers?

Generics are replicas of famous trademarks medicines developed by another company. Their cheap prices rise up the demand and move the medications to the top of market. India, Canada and European countries are generally accepted leaders in generic manufacturing.

Food and Drug Administration (FDA) strictly controls the process of incoming drugs. Before entering American market the medicines have been thoroughly reviewed and tested. FDA requirements for drug approving:

1. Generics are pharmaceutic equivalent of the original drug.
2. The manufacturer must prove that its medication has come through the same producing technology. Often one company produces active substance while another is responsible for finished product. Nevertheless, the batches of medicines which are going to come to the market must be reviewed and confirmed by FDA.
3. FDA inspectors always check the producer’s environment and review every step of production process.
4. The manufacturer must provide evidences that its medicament consists of the same active ingredient and guarantees the identical effect as the original trade mark.
5. The drug maker must render studies which show how the active ingredient affects the patient. Results are always analyzed by FDA medical scientists.
6. Complete information about inactive ingredients and wrong impact absence proofs are vital.
7. The remedy must be time-examined. Damaged or spoiled within a period pills never receive FDA authorization.
8. The packing must be appropriate for shipment and storing till the expiration date.

On the basis of the foregoing, approved generic drugs coming to the US market absolutely satisfy the state requirements, answer all world standards and do not have a negative impact on health.

USA Patents and Pricing Politics

When a new product comes to the pharma market it has a trademark name and is being used in the prescription lists. The drug is defended by the patent and supposed to be produced by only one maker. The patent owner sells the particular medicine and gets profit.

Patent duration in America is determined by statute and arranged for 20 years since the application date. Period may vary depending on manufacturer and the type of medicine. Since the clinical expertise might take a long time, actual patent period retrenches to 7-12 years.

Since the expiration date the patent can be reproduced or sold to other corporations. Consequently, the medicinal product is referred to as a generic drug. The medicine is allowed to be produced as generic if:

• the patent’s period ended;
• generic drug maker proves that the patent held on the drug is unfounded;
• the drug has not been patented before;
• it is produced in countries which do not demand patent protection.

With coming of generic preparation to the pharmaceutical market the patent monopoly stops its existence. It immediately emboldens rivalry and meaningful fall prices for medicines respectively. As a result, life-important preparations become available for mass market at good prices. The patent owner may offer an updated formula and apply for patent renewal. New clinic tests start again then.

The prices of basic 269 prescription drugs were analyzed during the period 2009-2016: two-thirds of them rose by more than 50%, 44% more than doubled. Today Donald Trump’s administration modifies rough changes which would drive down the drug costs in the US.

The head of FDA is planning to use the authority of the agency to bring more price competitiveness. One of the priority way is approving affordable generics diminishing the role of high-priced drugs.

Adding generic products to American pharmacy is a powerful instrument for price regulations. The government is planning to approve 3 manufacturers of every generic drug. As a result, people will pay affordable price for medicines which really work well.

The price fall is inescapable but it will be done consecutively. The first generics is planning to have a slightly lower price of original trade mark, the second one will cost half cheaper, and the third generic version will be equivalent to 20% of brand drug price. This move is one of a few future actions regarding high drug costs.

The next step planned by FDA is announcement of 180 trade-marks which are out of patent cover and still do not have generics versions, plus 150 of them which were never offered to agency for review. This maneuver is expected to be a good business opportunity that should attract generic producers. FDA approvals speed will be also under reconstruction.

Hence, sooner or later generics are going to become a great part of big pharma in America.