ein Blog von nvestorz.com
The FDA has fallen weeks behind schedule in responding to select NDA's and PDUFA's. While people across the globe continue to fall ill, suffer and die from disease and debilitations, American drug research and development companies such as Cell Therapeutics (NASDAQ:CTIC), Hemispherx Biopharma (AMEX:HEB), BioDelivery Sciences International (NASDAQ:BDSI), Discovery Laboratories (NASDAQ:DSCO), Acura Phamaceuticals (NASDAQ:ACUR), King Pharmaceuticals (NYSE:KG) and Genta (OTC:GNTA) sit by anxiously awaiting word from the FDA on their medical discoveries - drugs that have demonstrated themselves to be paramount in effectiveness to combat many of these diseases and debilitations.
Stock investors have become impatient with the constant stalling of the FDA. They have set out to try to find answers, to now understand why it is that an agency of the government of the United States, charged with the approval of new drugs for the American marketplace, is withholding drugs such as Ampligen and Genasense from the people.
In their search for the reasons why, many investors have theorized that the hold-ups by the FDA are due to FDA chief Margaret Hamburg and her husband Peter Fitzhugh Brown. On May 26, 2009 The Wall Street Journal reported that Margaret Hamburg and Peter Fitzhugh Brown were heavily invested, both directly and indirectly, in drug company stocks and that they were being required to divest themselves of their holdings due to underlying conflict of interest issues.
Adequate time has lapsed since that article was published for the FDA chief and her husband to comply with the requirement that they divest themselves of their drug stock holdings and associations. Still, weeks have come and gone and no further word has been reported in the media (that I am aware of) as to the compliance of Margaret Hamburg and her husband.
There are other theories as well. Some of them ludicrous and some worthy of contemplation. One theory argues that the FDA is simply overworked and that the additional duties and responsibilities imposed upon them by the new Family Smoking Prevention and Tobacco Control Act only add to the workload and slow down the wheels of progress even further.
The FDA was already behind schedule with NDA responses prior to the Family Smoking Prevention and Tobacco Control Act. To argue that the FDA has fallen behind in their duties to the people due to this Act adding to their workload is, in itself, a ludicrous argument.
It would be more believable to claim that drugs developed by U.S. companies aren't being approved by the U.S. Food and Drug Administration in a timely manner because the U.S. government is indirectly outsourcing drug development to foreign companies in lieu of American companies through the drug approval process.
According to records returned by the FDA's search engine at accessdata.fda.gov, the FDA approved a total of 123 drugs during the three month period of April to June, 2009. Of those 123 drug approvals -
79 of those drugs (64.2%) were developed by companies either located outside of the United States or which are wholly owned subsidiaries of companies located outside of the United States, and
Nearly half (36, or 45.6%) of those drugs were developed by companies either located in India or which are wholly owned subsidiaries of companies located in India.
With only 44 of the drugs approved during that time period being developed by American companies, it would appear as though the FDA's preference for Indian drug research and development companies have become a viable threat to the success of American drug companies.
And what of those 44 American drug research and development companies? As a sideline, it's interesting to note that 27 (61.4%) of the American drugs approved by the U.S. FDA were developed by companies that are privately held (they do not have stocks that trade on the public markets). How this tidbit of information fits into the grand scheme of things is anybody's guess, but it certainly leaves room for more conspiracy theories.