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FULL TEXT OF FDA'S RESPONSE TO QUESTIONS FROM FOX 13 INVESTIGATIVE REPORTER GLENN SELIG

1. What is the FDA's knowledge of insulin dependent diabetics who claim they cannot stabilize on Humulin and require beef or beef/pork animal insulin?

There are patients who report that they have more hypoglycemia with human insulin than with animal insulin. For these individuals, pork insulin continues to be available (Lilly's Iletin 2 line) in the U.S. Patients who believe that they cannot use human insulin can use pork insulin. It is notable that since the approval of the first human insulin product in the early 1980's, most newly diagnosed Type I diabetics are treated from the start with human insulin.

For some patients being treated with animal insulin, the switch from animal insulin to human insulin may be complex. The drugs are not directly interchangeable for a variety of reasons. Intrinsic characteristics of the drug products that affect their speed of onset and duration of action may lead to more or less pronounced effects on glucose levels depending on the specific product used. In addition, most people taking animal insulins develop antibodies to the foreign insulins that affect speed of onset and duration of action. When such individuals switch to human insulins, the levels of these antibodies fall such that the speed of onset and duration of action of the human insulins are not similarly affected.

For these and other reasons, diabetics who switch from animal to human insulin products should do so under the guidance of a physician and may need to initiate therapy with a lower dose of the human insulin and carefully titrate their human insulin dose.

None of the points mentioned above is intended to suggest differences in the safety of animal insulins versus human insulins. All insulins can cause hypoglycemia, an adverse effect that may be associated with severe consequences including seizure, coma, heart attack, stroke, and in rare instances, death. It is important to note that most patients can switch to human insulin without difficulty.

2. Does the FDA acknowledge that Humulin may not work well for some people? If so, what would the approximate number be?

See the answer to question 1. As above, most patients are able to switch from animal insulins to human insulin without difficulty. Nevertheless, this switch should be undertaken with physician supervision, and, as stated previously, pork insulin products are still available in the U.S. for those patients who believe that they cannot use human insulin. We do not have a reliable estimate of the number of patients who believe that they cannot use human insulin.

3. What is the FDA doing to help these diabetics?

As you know, Lilly recently stopped U.S. marketing of Iletin 1 (beef/pork insulin mixture containing mostly beef insulin). Lilly's decision to stop marketing Iletin 1 was a corporate decision and was not made at the request of the FDA. Thus, at present no beef insulin-containing product is marketed in the U.S., however, as noted above Lilly continues to market a pork insulin product in the U.S. It is important to note that there has not been a pure beef insulin product on the market in the U.S. for a number of years.

The FDA is willing to work with any sponsor interested in marketing animal insulins in the U.S. Approval of any new animal insulin product will require that the sponsor submit data to the FDA to assure that the new insulin product meets the standards established by the Food, Drug, and Cosmetic Act for safety, effectiveness, and quality. The FDA has met with sponsors interested in marketing beef insulin products in the U.S. on a number of occasions and has worked to reduce the regulatory burdens the sponsors must meet to obtain FDA approval for their beef insulin products. An important safety concern for beef insulin is possible contamination with the agent that causes bovine spongiform encephalopathy (BSE). This concern raises issues related not only to the sources of bovine pancreas (i.e., from BSE-free herds) but also related to processing in designated plants to avoid potential contamination with BSE from materials from non-BSE-free herds.

In addition, FDA has exercised its regulatory discretion to allow personal importation of unapproved beef insulin (up to a 6-month supply) by patients whose doctors certify cannot be controlled on other available therapy.

4. Why isn't the FDA doing more to make doctors and diabetics aware that a problem may exist?

The FDA website has detailed information on the beef insulin issue, including the safety concerns surrounding the use of non-U.S. approved beef insulin products. In addition, it provides explicit information on importation for personal use. While FDA cannot endorse the use of products that have not been determined by FDA to be safe and effective for human use, we do describe the mechanism by which patients can obtain beef insulin (up to a 6-month supply) for personal use through special importation procedures. As noted above, FDA has exercised its regulatory discretion to allow personal importation of beef insulin.

5. How does the FDA interpret its own adverse reaction data where diabetics and/or their families have blamed Humulin or Humulin for deaths and hospitalizations.

Insulins, whether animal or human, can cause hypoglycemia and serious adverse reactions related to hypoglycemia. As stated above, some individuals have difficulty switching from animal to human insulins. This should be undertaken with physician supervision, and if patients still cannot tolerate human insulin, pork insulin is available in the U.S. and beef insulin may be imported for personal use.

6. What investigating has the FDA done to follow-up on those adverse reaction reports?

We are aware of these reports and they have been evaluated through the same process that FDA uses to evaluate all adverse event reports received for marketed drugs. Adverse events related to hypoglycemia have been received for all types of insulin products, and underscore the importance of careful dosing and titration of insulin in addition to other interventions (e.g., dietary compliance) to assure the safe use of these drugs.

7. What dialogues have taken place between the FDA and CP Pharmaceuticals of the UK?

For reasons of confidentiality we are not at liberty to discuss interactions between FDA and a drug sponsor.

8. Why does the FDA consider the UK insulin a BSE risk when the company uses American cows?

Regardless of the specific commercial sponsor, the potential for BSE contamination of beef insulin is related not only to the source of livestock but also to the manufacturing facilities and equipment used to process the material into the final drug product. Material obtained from BSE-free herds may become contaminated if processed in the same facilities and using the same equipment that are used to process materials from herds that are not certified to be BSE free.

9. What is the FDA requiring the UK company to do to be able to sell and market its insulin in the US?

For reasons of confidentiality we are not at liberty to discuss interactions between FDA and a drug sponsor on development of a drug product for U.S. approval. FDA has met on several occasions with sponsors interested in gaining approval to market beef insulin in the U.S. and we remain committed to working with any sponsor interested in submitting the data necessary to gain FDA approval for beef insulin.

10. How long will that process take?

It is not possible to comment on how long the approval process for beef insulin might take. When FDA receives an application for approval of beef insulin that is satisfactory for filing and review, the application will be reviewed and a decision regarding approval will be made in the time frames required by the Prescription Drug User Fee Act as amended in 1997.

11. Can the FDA do anything to fast-track the process? Or is there a compromise that can be reached? If so, what would it take?

As noted above, FDA is willing to work with any sponsor that is interested in submitting an application for marketing of beef insulin that contains the data required to demonstrate the safety, effectiveness, and quality of their beef insulin product. As always, the FDA will entertain proposals from sponsors on how they may gather the necessary data in the least burdensome way, without compromising the safety of the product.

12. Does the FDA in any way consider this an emergency or a crisis?

As stated above, there are many insulin products available as options for patients with diabetes who require insulin for control. These include various types of human insulins, pork insulins, and, if necessary, the option of personal importation of beef insulin. Recognizing that some patients believe that their diabetes cannot be controlled without beef insulin, FDA has exercised its enforcement discretion to allow importation of unapproved beef insulin for personal use. We have worked to make the personal importation process less burdensome for patients including allowing patients to receive up to a six-month supply rather then the usual three-month supply. We believe that working with their individual physician, patients can utilize one or more of the available insulin options to treat their diabetes safely and effectively.

13. Some diabetics claim the FDA is "protecting them to death." What is your response?

As noted above, patients have many insulin options, including the option to obtain beef insulin through personal importation if their doctor believes that beef insulin is necessary for their care. We believe that in order to fulfill FDA's public health mission, the potential risk of BSE contamination of beef insulin must be taken very seriously and adequately addressed before any beef insulin product is approved for U.S. marketing. We have tried to balance these public health concerns with the needs of individual patients by exercising our enforcement discretion to allow personal importation of beef insulin.

14. Anything else the FDA would like to add relating to this that perhaps has not been covered in the questions and answers?

Nothing additional. Please direct patients and physicians to the FDA website for further information regarding beef insulin.

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