2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC58
Submitter : Dr. Kenneth Gwirtz Date & Time: 06/03/2004 04:06:14
Organization : Indiana University Dept of Anesthesia/ Pain
Health Professional
Category :
Issue Areas/Comments
FDA's Ability to Assure Safety
1. What should FDA do to assure safety of imported products?
There is no way to assure that adverse events with respect to a given preparation have been adequately followed up in another country.
Regulation by Foreign Health Agencies
25. What protections do other countries have in place to ensure the safety of drugs that are exported or transshipped from their country to the United States?
Internet traffic of drugs risks making ALL regulation mute, and foreign suppliers risk reversing YEARS of work by the FDA in insuring a safe and effective drug supply. Once this occurs, the FDA will be decapitated and literally be unable to insure that any of our drugs are safe. Why would you work so hard for so many years, and then abandon your mission to less regulated nations????
Regulatory/Legislative Issues
10. What, if any, limitations in current legal authorities may inhibit Secretary's ability to certify that prescription drugs imported into the US are safe
There is currently no way to ascertain that standards of purity and safety equivilent to that in the USA are inspected or monitored regularly in other countries. There is little we can do once these drugs are in our pharmacies and hospitals.
Technology
17. What anti-counterfeiting technologies are available and feasible to use to improve the safety of products in the domestic market as well as to prevent the importation of unapproved or counterfeited drug products?
As a researcher in the field of Anesthesia and Pain Management, it is absolutly impossible to develop new drugs for the future if we are so short sighted as to eliminate the potential profitabliltiy after the enormous cost of developement. Drugs of dubious purity, efficacy, and which capitalize on the enormous contributions of legitimate workers in the pharmaceutical industry will scuttle ALL future developement--- and are not worth the risk of harming the future of civilized medical advancement.