2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC33
Submitter : Mr. JAMES SIEBEN Date & Time: 05/18/2004 11:05:33
Organization : METROPOLITAN ANESTHESIA NETWORK, LLP
Health Professional
Category :
Issue Areas/Comments
FDA's Ability to Assure Safety
1. What should FDA do to assure safety of imported products?
INTENTIONALLY LEFT BLANK.
GENERAL
GENERAL
Metropolitan Anesthesia Network, L.L.P. (MAN) supports prescription drug reimportation as outlined in S. 2328, the Pharmaceutical Market Access and Drug Safety Act of 2003.

- MAN is a partnership of over 80 physician anesthesiologists practicing at regional and metropolitan medical centers, as well as ambulatory surgery centers, in the greater Twin Cities metropolitan area.

- In our hospital based perioperative practice we treat a large percentage of Medicare patients who, because of their advanced age, are our most vulnerable patients, and the patients most in need of safe pharmaceuticals.

- Providing them proper market access to safe prescription drugs is imperative for their overall health.

- It is the MAN position that pharmaceutical market access for consumers, retailers, and wholesalers, to FDA approved prescription drugs from FDA approved facilities, whether those facilities are inside or outside of the United States, is necessary in order to give seniors, and other Americans, this market access to quality prescription drugs.

- States such as California, Wisconsin, Iowa, Illinois, Massachusetts, New Hampshire, New York, Vermont, and Minnesota, as well as major cites such as Boston, are already taking steps to increase citizen access to safe pharmaceuticals through importation and reimportation.

- We view this as a market access and a patient safety issue.

- As a result MAN supports the legal mechanism outlined in S. 2328 as the best way to deal with pharmaceutical market access.

For more information on the MAN position on Pharmaceutical Market Access and Drug Safety, please contact the MAN Government Relations Attorney at jsieben@hmadoc.com or 763.852.0443.

Physician Anesthesiologists Committed to Safe Pharmaceutical Access

Impact of Unapproved Drugs:
1: What is the scope and volume of unapproved drugs entering the United States through mail shipments and at border crossings?
INTENTIONALLY LEFT BLANK.
2. What are the safety concerns posed by these products?
INTENTIONALLY LEFT BLANK.
3. What evidence exists to substantiate these concerns?
INTENTIONALLY LEFT BLANK.
4. Can they be quantified?
INTENTIONALLY LEFT BLANK.
5. What is the scope and volume of FDA-approved drugs commercially available in other countries?
INTENTIONALLY LEFT BLANK.