Personal Importation Policy (PIP)

Transcription

1 Personal Importation Policy (PIP) CDR Paras Patel, R.Ph., MBA US Food & Drug Administration Center for Drug Evaluation and Research Drug Shortage Staff

2 Objectives Describe the purpose of the Personal Importation Policy (PIP) Provide qualifications of drugs and devices that may be eligible for importation Identify labelling recommendations Review potential documents that patients can encounter during importation

3 Personal Importation Policy: Purpose To allow import of unapproved drugs or devices in small quantities, for personal use or to continue treatment with a drug from a foreign country, that are not available in the USA Factors the FDA considers: -drug is unapproved and/or not available in the USA -drug is for serious medical illness, where there is no domestically available treatment -drug should not indicate a health risk that is unreasonable (safety of the patient is considered) -request must have affirmation of drug use, patient s and physician s information Policy protects patients from legal persecution on a case by case basis

4 Potential Pathway Patient/practitioner request for an unapproved product to get into the US. Patient has rare illness Patient finds treatment in a foreign country, not available in the US Product is shipped and detained at US border by Customs and Border Protection (CBP) Proper documents may be reviewed by FDA for consideration Release without detainment Detainment and hearing

5 Key points to consider for personal drug importation 1. Identify a safe source of the drug or device 2. Scale of import- 3 months supply 3. Notify the international source of labelling requirements 4. Physician supervision- letter explaining intent for drug use and other required information 5. Letter may be sent from the FDA if the package is detained at the border

6 What kind of drugs or devices can be imported? PIP allows patients to access unapproved drugs available in other countries for the following reasons: -Serious medical illnesses -Treatment is not available in the USA -Illnesses that began in another country-where therapy was started -No serious health risk to the patient Unapproved drugs that violate(import alert) FDCA cannot be imported Regulatory Procedures Manual - April 2013 Chapter 9 Import Operations and Actions. Pg

7 Can I get drugs from another country if they re less expensive? No. PIP does not allow importing FDA approved drugs that are cheaper in other foreign countries FDA cannot confirm the approved products made foreign are: properly manufactured safe and effective same formulations as in the FDA approved products Through discretion, PIP considers: unapproved drugs, with no equivalent treatment in the US, used for the treatment of severe medical conditions continuation of foreign begun treatment with an unapproved drug

8 How much drug can be imported at once? 3 months supply or less. Larger quantities will be returned to the sender or discarded if deemed unsafe.

9 Is a prescription required? No. However, a letter from a physician may be requested, for an appropriate decision, stating: 1. Name of licensed physician 2. Address of United States licensed physician, who is taking responsibility for the patient and the drug therapy 3. Signature and consent that the physician will supervise the use of the drug or device, which will only be used for patient (not for distribution) 4. Intended use of the drug

10 How should one label the product? Make sure the product is properly labelled: drug/device name/description on the product itself or piece of paper with drug information plus identification on the packaging that the contents is a drug *without proper labelling, a sample may need to be taken and sent to a lab which will delay receipt, possibly contaminate the product and remove drug that could be used on the patient

11 Can a patient notify the FDA before shipping the product to assure successful importation? No such requirements or procedures to recevice such a notification. Provide all required documentation/justification with the product that is to be shipped into the United States. Wait for a letter from the FDA when it arrives at the domestic port of entry.

12 Are forms required to import a drug? There are no forms to allow an unapproved drug for importation The Personal Importation Policy is used as a guidance by the FDA for enforcement discretion in certain situations Requests are analyzed individually, on a case-by-case basis Regulatory Procedures Manual - April 2013 Chapter 9 Import Operations and Actions. Pg

13 What forms could I receive from the FDA? A Notification of Detention and Hearing will be sent for unapproved drug products: This drug is not approved by the FDA. To release this product please provide: i. Documentation that product is for personal use, and for treatment of a serious condition ii. Include name and address of licensed physician who is responsible for your treatment using this product iii. Adequate documentation that the product is continuing treatment for a serious disease begun in a foreign country Regulatory Procedures Manual - April 2013 Chapter 9 Import Operations and Actions. Pg 9-84.

14 Release with Comment Form When a shipment is NOT denied entry: a. The drug or device is for personal use, and is unapproved in the USA b. The drug must be used under medical supervision c. FDA may detain future shipments of this product d. The patient s physician should consider enrolling the patient in an investigational study or applying for an appropriate Investigational New Drug (IND), compassionate IND, or Treatment IND exemption. Regulatory Procedures Manual - April 2013 Chapter 9 Import Operations and Actions. Pg 9-84.

15 If a patient follows these guidelines, will he or she be guaranteed to receive the imported drug or device? No. These are guidelines to provide clarity on the intent of the PIP policy. Each use of the PIP will be examined on a case to case basis.

16 Thank You for Your Time! FDA Homepage: Personal Importation: ntrolled Regulatory Procedures Manual: Manual/UCM pdf