2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC37
Submitter : Dr. Georges Benjamin Date & Time: 05/18/2004 11:05:45
Organization : American Public Health Association
Health Care Association
Category :
Issue Areas/Comments
GENERAL
GENERAL
May 13, 2004

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.

Re: Prescription Drug Importation Comments

The American Public Health Association appreciates the opportunity to submit written comments to the Food and Drug Administration (FDA), on behalf of the U.S. Department of Health and Human Services' (HHS) Task Force on Drug Importation. APHA is the largest and oldest organization of public health professionals in the nation, representing more than 50,000 members from over 50 public health occupations.

In 2000, APHA adopted a position paper 20006: Making Medicines Affordable: the Price Factor. In this position paper, APHA expresses its support for approximating price parity with other countries by legalizing the re-importation of products that U.S. manufacturers sell abroad (attached). While we do not believe this is the only solution or a permanent solution to controlling the costs of prescriptions drugs in the United States, we do believe that this is an appropriate and timely, if perhaps temporary measure to curb the skyrocketing costs of prescription drugs paid by America's seniors.

The enormous costs of prescription drugs effects all Americans, but has an especially negative impact on those with marginal incomes, the same group of Americans who have the highest rates of cardiovascular disease and cancer and diabetes -- all preventable diseases. The re-importation of FDA approved drugs from countries such as Canada, the European Union and other countries with similar regulatory and safety structures that have been manufactured in FDA inspected plants is one solution.

Regarding the safety of drugs imported from Canada, we are unaware of an epidemic of unsafe drugs being imported into the United States from Canada. All of the entities involved in the importation of prescription drugs from Canada are trusted agents. We probably know more about the infrastructure of the healthcare pharmaceutical community, from physician to pharmacist to pharmacy, wholesaler, some of the secondary sellers, the pharmaceutical companies, than any other manufacturing entity. We know where every doctor went to medical school. We in some cases know where they went to high school. We know so much about this system; the fact that we cannot string together an effective system to effectively import pharmaceuticals means that we just have not made this a priority, it does not mean that it is not a feasible solution to reducing the costs of prescription drugs for consumers in the United States.

We are especially encouraged by two legislative initiatives in Congress, S. 2328 and H.R. 2427, that have been introduced this Congress to allow for the re-importation into the United States of FDA-approved drugs that have been manufactured in FDA-inspected plants. H.R. 2427 was overwhelmingly passed by the House of Representatives by a vote of 243 - 186 in July 2003.

Recently, a number of retail drugstore chains, including CVS and Walgreens, insurance companies, including Oxford Health Plans, and 19 state attorneys general have announced support for drug re-importation from Canada. In addition, in a recent statement HHS Secretary Tommy Thompson called the re-importation of prescription drugs from Canada inevitable.

We urge the FDA to move forward in cooperation with Congress to allow for the safe re-importation of prescription drugs from abroad.