PLEASE NOTE THAT THE FDA URL APPEARS NOT TO FUNCTION, AND THAT IT TAKES THEM 2 MONTHS OR MORE TO RESPOND TO EVEN THE MOST SIMPLE COMMUNICATIONS ON THE HUMAN/BEEF INSULIN ISSUE.

  DEPARTMENT OF HEALTH & HUMAN SERVICES

October 13, 1999

Mr. David G. Groves
1102A Thornwood Drive
Birmingham, AL 3 5209-2223

Dear Mr. Groves: 

This is in response to your letter of August 2, 1999 to Dr. Henney and your e-mail of September 13, 1999 to Dr. Henney and myself.

We are aware there will be no FDA-approved beef insulin product marketed in the U.S. As was stated in previous correspondence with you, the Federal Food, Drug, and Cosmetic Act does not provide FDA with authority to require a manufacturer to continue making a product. We are concerned that American consumers have access to needed medical products. FDA is using its enforcement discretion and allowing personal importation of unapproved drugs that are medically necessary and not available in the U.S. on a case-by-case basis. I am enclosing a copy of a document that was recently posted on CDER’s web page (http://www.fda.gov/cder/druginfo) that answers frequently asked questions and provides instructions for patients wishing to import beef insulin from a foreign source. This information was posted to assist consumers and provide information on FDA’s import policy of beef insulin for personal use. Consumers who write to the FDA requesting to import beef insulin will also be provided a copy of this document.

The FDA has no regulatory authority over the U.S. Department of Agriculture (USDA) and the U.S. Customs Service. Consumers wishing to import beef insulin must meet the requirements and regulations of these agencies as well as the FDA. Specific questions regarding the requirements and regulations of these agencies should be directed to the appropriate agency.

Manufacturers that wish to sell their drug products, (such as beef insulin) in the U.S. must have FDA marketing approval. I can assure you that staff at the FDA are available to work with manufacturers wishing to obtain marketing approval for their drug products and will give prompt review to data submitted in support of an application. However, please note that confidentiality laws prohibit FDA from commenting on any drug under development or application received in CDER, unless the information has already been published.

I hope this information is useful to you.

Sincerely,

/s/

Celia A. DeLawter
Executive Secretariat (HFD-6)
Center for Drug Evaluation and Research

Enclosure 

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