Thursday, June 27, 2013

Reminder Again: Obtaining an IND for Estriol

Obtaining an IND for Estriol

Some menopausal hormone therapy drugs compounded by pharmacies contain the ingredient estriol. Estriol is not a component of any FDA approved drug and it has not been shown to be safe and effective for the uses for which it is being prescribed.
Under a well-established policy, pursuant to an Investigational New Drug Application (IND), FDA permits drug compounding with active ingredients that - like estriol - are not components of FDA-approved drugs. The Agency's position has been improperly cast as a ban on estriol. But FDA has repeatedly stated that it respects a healthcare provider's decision that his or her patient should receive estriol.
At the same time, FDA must assure that patients receive accurate information about the risks and benefits of unapproved drug therapies so that they can make informed decisions about those therapies. The requirement for patients to give informed consent when receiving a product under an IND ensures that patients receive important safety information. Another advantage of INDs is their requirement that practitioners collect and report adverse event information to FDA.
There are some misconceptions that obtaining an IND is a costly, cumbersome, and time consuming process. To the contrary, INDs are well known, well understood, and widely used in the healthcare community. Thousands of physicians use INDs every day to treat patients with drugs that have not been approved by FDA. FDA does not charge a fee to file an IND, although review fees may be charged by private Institutional Review Boards. In addition, FDA has streamlined the IND process for estriol to make it as efficient and convenient as possible for practitioners, while still maintaining patient safety.
Under this streamlined process, FDA is willing to accept INDs covering multiple patients, on behalf of multiple health care providers, and for a range of doses. The general requirements for practitioners filing an IND application for estriol are:
Drug formulation and chemistry information including:
  • Names and addresses of the pharmacies making the drugs
  • Attestation from the pharmacies that they will use only USP/NF grade ingredients and adhere to USP processes and procedures when preparing the compounded products
  • Detailed description of the drug formulation that will be used (ingredients, quantities, and production processes)
Clinical information including:
  • Number of patients
  • Types of symptoms that will be treated by the drugs
  • Dose ranges for each formulation
  • Monitoring procedures, including safety monitoring
  • Copy of current medical license of the practitioner
For more information regarding IND or new drug application submissions for drugs containing estriol, please contact Margaret Kober in the Division of Reproductive and Urologic Products at 301-796-0934.
Please submit all completed IND applications for estriol to the following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705
Attn: Margaret Kober

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