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Medical stephoscope and gavel on table

December 1st, 2016 - 0 Comments

A group of scientists and physicians sent an open letter in 2009 to the then US President Barack Obama, signifying how pharmaceutical and political lobby groups interfere with the functioning of the FDA. Another case that highlighted the interferences was of an antihypertensive drug made by one of the biggest pharmaceutical companies. The then FDA commissioner approved the drug, which was later linked to approximately 140,000 heart attacks and 60,000 deaths. The commissioner, after resigning, joined the same pharmaceutical company in the PR department.

A similar case involving a medical device, Menaflex, is also of interest. Menaflex, used to treat knee injuries, was approved ‘surprisingly fast’ and without heeding the repeated scientific rejections passed by the FDA scientists. On closer inspection of the various documents and emails, this was later termed as a ‘special treatment’ doled out to the device due to political and industry lobby groups.

Let us also take a closer look at FDA’s action against the generics industry in 2014 when the Ranbaxy Toansa plant unit was blacklisted by FDA. Three interesting coincidences occurred here:

  1. Ranbaxy markets its products to the US, the East and West Europe, Middle East, Latin America, South and South East Asia, Africa and the Asia Pacific regions. Yet, none of the regulators of those countries issued an import alert or even a warning to the production facilities. So, the benchmark for adhering to the GMP approval by the FDA is more stringent than the other regulators and ‘why’ is the bone of contention between many stakeholders of the pharmaceutical industry.
  2. Another intriguing coincidence is the time of the import ban. Ranbaxy had got the rights to launch the generic versions of the multi-billion dollar drugs facing patent expiry. These drugs provided the largest share of revenue to the respective companies and were amongst the top products of all time.
  1. The price of all the blockbuster drugs facing patent expiry were increased manifold after the generics were disallowed from entering the market due to the import ban. This caused an aftermath of several billion dollars in healthcare expenditure.

All these may sound extremely flimsy to the audience.  But, these are facts no one should ignore. The gains for the ‘big pharma’ by avoiding or even delaying the generic entries are astronomical as these drugs are the ‘blockbuster’ drugs that generate more than a billion in revenues per year. While Indian patent laws are criticized mainly by the US, generic drugs or the alternative system of medicines like homeopathy and Ayurveda are suppressed by the lobby groups.

Making a branded drug evergreen or extending its patent life are always followed by vigour in case of the big pharma. Many cases of litigation lawsuits without any valid proof and ‘pay for delay’ agreements with the generics can be seen regularly. The Hatch-Waxman legislation was enacted into law by the US government for this anti-competitive foul play. It promotes generic entry into the market swiftly by taking into account the various hurdles introduced by the innovator. It even guarantees a six-month exclusivity period for the ‘first to file’ generic company. Also, the Honourable Supreme Court of India passed judgements that prohibit the use of anti-competitive behaviour of the pharmaceutical companies (even of the Indian generics industry). Recently, South Africa also adopted a similar version of the Indian patent laws, even after a big campaign was initiated by the big pharma to entice the government, termed as a “genocide” plan by one of the ministers. But, various loopholes still exist in these laws which are and can be used for the benefit of the big pharma.

 

Source of the image : http://www.businesstoday.in/sectors/pharma/tpp-to-have-serious-implications-for-pharma-industry/story/236912.html

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