A lot of attention was garnered by an article which I published on June 1 titled 'A Theory Behind FDA Approval Delays'. The article, linked and reprinted on discussion boards as far away as Germany, gave investors a new point of view from which to contemplate the matter of FDA drug approval delays and it redirected discussions along new paths never before considered.

After reading the article, which was reprinted at WallStreet-Online in Germany, one investor proudly contributed on behalf of the Indian people this statement (translated using the Google page translator):

Strange that most software developed by Indians, and is written?
Funny the most successful businessmen among the top 10,000 come from India?
Strange that the Indian economy is booming where others weak?

I have many times over a long time and worked in India of which one can only learn if you have no prejudices.

Ah yes, the Indian medicine is viewed worldwide and respktiert, even in homeopathy, they are up front with it and have an uncanny knowledge for centuries.

And so begins my next examination of the 123 NDA, ANDA and BLA approvals by the FDA in the three months of April to June, 2009. Note that the actual count of approvals by the FDA is 124; the last approval was excluded from my observances because it had not been made available in the FDA database at the time of my data gathering.

Considering that a single application to the FDA for drug approval can list more than one drug - similar drugs of differing dosage sizes constitute different drugs - a total of 198 drugs were approved in the second quarter of 2009. The applications for these 198 drugs came from companies which are either located in or subsidiaries of companies located in 14 countries around the globe. These 14 countries include the United States of America.



With a total of 74 approved drugs (37.37%) in the second quarter of 2009 being attributed to Indian companies, it is without doubt that Indian drug companies have dominated the drug approval processes of the FDA. However, just because Indian drug companies are receiving more drug approvals from the FDA, this does not indicate in any way that India drug companies are leaders in drug research and development. If anything, a closer examination of the data provided by the FDA points to the assumption that the Indian drug companies contribute more towards the duplication of drugs already made available by drug companies of other countries and less towards the development of new and better cures and treatments for the illnesses of mankind.

In April of 2009, a total of 49 drugs having therapeutic equivalents were approved by the FDA. The majority of those drugs (17 or 34.69%) were submitted by American companies. The second highest number of approved drug submittals (15 or 30.61%) came from Indian companies. However, for the drugs submitted by U.S. companies, there were a total of only 81 therapeutic equivalents in comparison to the 192 known therapeutic equivalents for the drugs submitted by Indian companies.

In May of 2009, a total of 50 drugs having therapeutic equivalents were approved by the FDA. The majority of those drugs (19 or 38%) were submitted by Indian companies. The second highest number of approved drug submittals (14 or 28%) came from American companies. For the drugs submitted and approved in May, there were a total of 228 known therapeutic equivalents for the Indian submittals in comparison to only 78 known therapeutic equivalents for those submitted by American companies.

In June of 2009, a total of 64 drugs having therapeutic equivalents were approved by the FDA. The majority of those drugs (36 or 56.25%) were submitted by Indian companies. The second highest number of approved drug submittals (16 or 25%) came once again from American companies. For the drugs submitted and approved in June, there were a total of 412 known therapeutic equivalents for the India submittals in comparison to only 72 known therapeutic equivalents for those submitted by American companies.

There were 163 drugs having therapeutic equivalents approved by the FDA in the second quarter of 2009. For these 163 drugs, there are known to be a total of 1,451 known therapeutic equivalents. Of those known therapeutic equivalents, 832 (57.34%) of them are attributed to the 70 drugs which were approved for Indian companies.

While Ampligen, a new and powerful drug that can help in combating the H1N1 virus - a virus for which there is no known cure - awaits the turning of the slow wheels of progress beneath the FDA behemoth, people fall ill and die.

While Pixantrone, a new and potent treatment for non-Hodgkin's Lymphoma, awaits the untangling of the bureaucratic red tape that has held it back from the dying masses, the Food and Drug Administration of the United States busies themselves with the approval of drug applications which serve not even to reinvent the wheel, but to redevelop it over and over again.

While Genasense, the only drug that has thus far demonstrated itself to be effective in treating advanced melanoma, awaits the announcement of its fate by the FDA, Indian drug companies are reveling in their approval to mass produce 70 drugs for which more than 830 therapeutic equivalents already exist in the open pharmaceutical marketplace.

While these drugs gather dust awaiting the decision of the FDA, there are tens-of-thousands of people across the globe - men, women and children, flesh and blood, love and life - who cry, suffer, tremble in fear and die.

One can only ask the reason why.

Why is it that the world needs a 27th duplicate of cetirizing hydrochloride allergy medicine (Company: Unichem - India), but we don't need a single version of a medicine to save lives from melanoma?

Why is it that unique, life saving drugs for which no known therapeutic equivalents exist are being passed over by the Food and Drug Administration in favor of approving a 4th identical duplicate of Ibuprophen (Company: Marksans Pharmaceuticals - India) - a pain reliever for headaches!

There is no word from the FDA to explain their delays in approving drugs. There is no word from them to justify their selection of Indian drug company applications over the drug applications of drug companies throughout the remainder of the world. There is not an utterance from the FDA to make a shred of sense out of their approval of countless drug applications for drugs that already have therapeutic equivalents in the marketplace while new, improved and necessary medical science remains ignored.

And so, we can only theorize.

Tags: Pixantrone Genasense Ampligen Fda Approval India Indian Drugs Lymphoma Mela

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