2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC59
Submitter : Ms. NEDRA AUSTIN Date & Time: 06/03/2004 04:06:52
Organization : California Association of Black Lawyers
Category :
Issue Areas/Comments
Liability Issues
24. If liability concerns do exist, what liability protections do you believe should be implemented?
The California Assocation of Black Lawyers which represents the interest of over 5,000 African American attorneys and judges, is pleased to submit comment to the HHS Task Force on Drug Importation Docket No. 2004N-0115. Although importation of prescription drugs raises various concerns regarding safety, our comments will be limited to the liability and juridicational concerns.

It is not uncommon for foreign businesses doing business with US citizens to require those individuals to waiver their right to pursue legal action. With respect to prescription drug importation to following waiver language is standard in many of these transactions: I release (insert name of business) from any and all liability whatsoever associated with or connected to my medical records and/or the use of any or all the medication(s) prescribed to me and any adverse effects that I may suffer from these medication(s). By signing this document, I agree to release liability and hold blameless the physicans, affiliates, directors, officers, employees, representatives, and independent contractors of (insert name of business) from all causes of actions, suits, penalties, liens, judgments, liabilities, obligations, losses, actual or consequential damages, actual or threatened claims which may arise at any time by reason of relating to, arising directly or indirectly out of any matter whatsoever related to the prescribing or dispensing of my prescription medication(s).

If the Food and Drug Administration (FDA) is considering establishing standards for the safe importation of drugs from foreigh countries, such standards must protect the right of individuals to seek redress through the United states legal system. US citizens should not be required to waiver their right to pursue legal action against any business engaged in the practice of exporting prescription drugs into the United States.

Our other concern relates to the jurisdictional question. The FDA should ensure that any business engaged in the practice of importing drugs into the United States agree to submit to jurisdiction of US courts. Individuals should not have the burden of pursing legal redress on foreign soils. Failure to address the jurisdictional question will have the effect of eliminating an individuals right to pursue legal action due to the prohibitive cost of bringing an action in another country.

Thank you for the opportunity to submit comments regarding Drug Importation. We appreciate your consideration of these concerns.