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FDA Negligent on Drug Safety


Attorney William Marler is pressing for a separation of food-related responsibilities to be removed from the U. S. Food and Drug Administration and transferred to a separate Food Safety and Nutrition agency to be established. EGG-NEWS has advocated for a separate agency since the establishment of the newsletter over ten years ago.  There is an aspect to the “Take the F out of FDA” campaign initiated by Atty. Marler that motivates action.  It is generally acknowledged that the FDA has traditionally focused on drugs and medical devices to the detriment of food-related issues.  This is evidenced by the series of public health events that suggest dereliction of responsibility. 


It is the contention of EGG-NEWS that the FDA may also be failing in its drug-related activities. This presumes that if the “F” were to be removed from the FDA that the Agency could concentrate on oversight of drugs. 


The recent emergence of keratitis and panophthalmitis associated with imported eye-drops contaminated with a multi-drug resistant Pseudomonas aeruginosa is an item of concern. The implicated eye-drops were manufactured by Global Farmer Healthcare Pvt. in Tamil Nadu State, India. This facility was not ever visited by the FDA prior to the emergence of the problem in the U.S.  The recent inspection revealed serious deviations from acceptable manufacturing practice including failure to conduct sterility assays, unacceptable cleaning practices and substandard construction and work surfaces. Important observations but academic for the numerous patients blinded by the contaminated product.


Given the fact that a high proportion of generic and OTC products are manufactured in Asia, it is questioned whether the FDA is fulfilling its responsibility to U.S. consumers by ensuring that products are safe and effective. Congress needs to inquire as to the extent of monitoring of foreign plants and the frequency of inspections. 


In an April 3rd release, the Agency stated, “The FDA’s highest priority is protecting public health – this includes working with manufacturers to quickly remove unsafe drugs from shelves when they are identified.”  This is a characteristic, reactive approach basically using U.S. consumers as an indicator for deviations in quality assurance.


If the FDA does not have the resources or the inclination to become more proactive and inspect foreign manufacturing facilities, it should request additional funding and develop programs for surveillance.


Advocates for separation of food-related aspects from the current FDA should point to the fact that the “D” component of the Agency is also functioning at a level that is inconsistent with the needs of consumers.


If the FDA displayed diligence in oversight of drugs, then a case might be made for the Agency to remedy deficiencies in the area of food safety.  Given the belated, inappropriate and fuzzy reorganization as devised by the Commissioner, Dr. Robert Califf, there is little prospect for a self-generated rejuvenation. 


Bipartisan Congressional involvement will be required to remedy the current deficiencies in the FDA.  More money is not the single solution.  A profound change in culture and orientation is required that can only be achieved through revisiting and amending the Food, Drugs and Cosmetics Act.  But then there are lobbyists ---.