E-DRUG: DRA or FDA (5)
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Dear E-Druggers:
With respect to Wilbert's e-mail raising questions regarding changes to Mongolia Food and Drug Relations, I would offer (below) the following comments interspersed into Wilbert's original e-mail
With Best Regards,
Michael Anisfeld
313 Pine Street (Ste 204)
Deerfield IL 60015, USA
e-mail: manisfeld@globepharm.org
ph: USA +1 847 914 0922
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Dear E-druggers,
Mongolia is considering to upgrade its existing drug regulatory unit to a Food and Drugs Authority, with access to a joint Quality Control laboratory and inspectorate.
Is anyone aware of lessons learned when moving from a DRA to an FDA?
Or has there been any evaluation or comparison between having an DRA or an FDA?
'DRA' USUALLY STANDS FOR DRUG REGULATORY AGENCY; 'FDA' USUALLY STANDS FOR A FOOD AND DRUG AGENCY/AUTHORITY.
IN WORK I HAVE PERFORMED IN GHANA, SRI LANKA, AND OTHER COUNTRIES (WITH 15 OTHER NATIONAL DRUG AGENCIES), I HAVE FOUND THESE TITLES TO BE USED INTERCHANGEABLY WITH LITTLE DISCERNABLE DIFFERENCE BETWEEN THEM.
Who should control biologically active products (now classified as food supplements; they are not medicines as they have no evidence-based indications; but they look like medicines and are sometimes promoted as if they are medicines)
THERE IS CONFUSION HERE.
BIOLOGICALLY ACTIVE PRODUCTS CAN BE CLASSIFIED AS FOODS
E.G. PRO-BIOTICS USED IN YOGHURT PRODUCTS; OR THEY CAN BE CLASSIFIED AS DRUGS
E.G. INSULIN.
YOU WILL NEED TO BE VERY CAREFUL IN YOUR DEFINITIONS. OBVIOUSLY PRO-BIOTICS ARE BETTER SUITED TO CONTROL BY A FOOD AGENCY; WHILE INSULIN IS BETTER SUITED TO CONTROL BY A DRUG AGENCY.
Should veterinary medicines be controlled by the DRA (as they are medicines) or by the Food Authority (as they used by farmers to grow animals or produce meat)?
IN ALL COUNTRIES THAT I PERFORM INSPECTIONS/AUDITS, VETERINARY PRODUCTS ARE TREATED IDENTICALLY TO DRUG PRODUCTS AND THEIR REGISTRATION AND INSPECTION BY DRA'S IS HANDLED BY THE DRUG FOLKS. IF YOU CHECK THE GMP REGULATIONS IN THE USA, EUROPE, AUSTRALIA, AND ALL MAJOR MARKETS, THE REGULATIONS FOR REGISTRATION AND THE REQUIREMENTS FOR MEETING NATIONAL STANDARDS ARE IDENTICAL.
And how to deal with possible conflicts of interest between a Ministry of Health (protecting humans and public health) and a Ministry of Agriculture (promoting more food production and supporting farmers)?
IF YOU DEFINE PRODUCTS CAREFULLY AS EITHER FOODS OR DRUGS (SEE BIOLOGICAL EXAMPLES PROVIDED ABOVE) WHY SHOULD THERE BE ANY CONFLICT OF INTEREST.
THE UNITED STATES HAS THE "FOOD AND DRUG ADMINISTRATION" (FDA) WHICH HAS REGULATIONS AND PERFORMS INSPECTIONS GOVERNING THE MANUFACTURE OF PROCESSED FOODS (21CFR110). THE FDA IS MOST CONCERNED WITH FOOD SAFETY AND FOOD LABELING. FDA DOES NOT TYPICALLY GET INVOLVED WITH FARMERS (ALTHOUGH THE RECENT OUTBREAK OF SALMONELLA, EVENTUALLY TRACED TO CONTAMINATED SPINACH WAS AN EXCEPTION).
THE UNITED STATES DEPARTMENT OF AGRICULTURE (USDA) DEALS WITH RAW AND PROCESSED FOODS. E.G. MEAT PROCESSING TO MAKE HAMBURGERS FALLS UNDER USDA, WHO HAVE FULL TIME INSPECTORS IN MEAT PROCESSING FACTORIES.
A GOOD, SIMPLISTIC, EXPLANATION CAN BE FOUND AT
http://www.ehow.com/about_5453728_fda-vs-usda.html
FOR THE GOOD OF THE NATION, ANY FOOD AGENCY AND DRUG AGENCY NEED TO WORK TOGETHER TO PROMOTE PUBLIC HEALTH. IF THE PRODUCTS EACH AGENCY IS REPSONSIBLE TO REGISTER/MONITOR IS CAREFULLY DEFINED, THERE SHOULD BE NO CONFLICT OF INTEREST BETWEEN THEM.