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Change in FDA approval rules- A mandatory one to lower the cost of generic drugs

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Recently, leading pharmaceutical companies of US deliberated on the ways and means to lower the cost of generic drugs. This news was flashed across all television channels in America. No wonder, it’s a surprise. Off late, the cost of generic drugs has increased manifold. In some cases, it has even shot up to five time higher, an unimaginable extent. Deliberations of these kind are not new to pharmaceutical companies operating out of US, as they convene frequent gatherings to discuss variety of issues plaguing the pharmaceutical sector. However, the recent occurrence caught the attention of lawmakers of the country, given the timing of the deliberations. As presidential campaigning has gained momentum, these pharmaceutical companies propose the lawmakers to push for amendments that revisits the FDA approval rules that is casting its loom on their operational cost, which in turn has forced them to increase the prices of generic drugs.

Factors that act as a bottleneck for price decrease

Experts say that, America is short of generic drugs despite huge number of pharmaceutical companies manufacturing various generic drugs.Especially the medications that can benefit Alzheimer’s sufferers . Despite its spiraling cost, the demand hasn’t come down. The cost of developing a generic drug has sky rocketed, as a consequence effect of the increase in the cost of raw ingredient. Compounding the problem was the mandatory compliance to the FDA approval rules with regards to generic drug manufacturing process. The stringent approval rules laid forth by FDA has put pharmaceutical companies in tenterhook. Health experts argue that, shortage of availability in generic drugs could be because of the FDA’s approval policy too. Fearing the time taken to obtain an approval, pharmaceutical companies continue to exhibit lackluster attitude in the manufacturing of generic drugs. Though natural remedies for arthritis are aplenty, there is no significant drop in the number of companies developing generic drugs for this treatment. According to a recently published statistics, the prices of one-third of the generic drugs witnessed price increase on a year-on-year basis, whereas 10% of the other generic drugs witnessed price rise that is doubled in comparison. There are certain archaic and cumbersome regulations in the FDA approval process, that is provoking pharmaceutical companies with immense expertise on producing generic drugs to take a back seat. According to a representative of a pharmaceutical company who participated in the recently held deliberations, it seems that the political establishment lacks the will power to force FDA to overhaul the generic drugs approval process.

How FDA can usher price decrease in generic drugs?

The erstwhile top management representatives of these pharmaceutical companies attribute the onus on FDA.  Even they couldn’t understand the rationale behind the price increase of klonopin for anxietyAccording to them, FDA should fast track the review of companies that is well-identified for incubating generic drugs with least competition in the US market. They opine to the view that, if less than three companies manufacture the same drug that should be accorded due consideration at the earliest instance. This in fact will cut down the cost required to manufacture the drug. The need of the hour is a faster approval process for generic drugs. Faster approvals would bring more pharmaceuticals companies into foray, and this will definitely fuel the competition. Once the competition becomes intense, there is going to be a downfall in the prices. The surprising finding is that, majority of the US prescriptions account for generic drugs, approximately 85%. Since, ramifications made in FDA approval rules doesn’t require the approval of congress, due changes can be brought in at the immediate instance with least complication. An off-the-beat recommendation would be to allow the sale of generic drugs approved by the drug regulatory authority of another country.

Let’s hope that the dawn is near for the people of US to purchase generic drugs without scarcity.

About Dr. Leana Wen