Prescription Drug User Fee Amendments of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 09, 2007)

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ELEMENTS TO ASSURE SAFE USE

Ms. MURKOWSKI. Madam President I rise to engage in a colloquy with the Senator from Wyoming and ranking member of the Senate Health, Education, Labor, and Pensions Committee, Senator ENZI.

First, I would like to thank the chairman and the ranking member of the HELP Committee for their efforts to address the issue of access to health care in frontier areas. Much of Alaska is a frontier area and it is not an easy task to access health care in general, let alone find a specialist to obtain needed medications.

Toward that end, I am pleased that the bill before us today recognizes the problem of access and provides a willing provider in a frontier area with the ability to receive the training and certification necessary to prescribe a drug that has potential serious risks. For clarification purposes, I would like to ask the Senator from Wyoming if it is the intent of Congress that section 202 of S. 1082, the FDA Revitalization Act, allows all physician and nonphysician health care providers in frontier areas to be able to receive ``training or certification'' so that the provider can prescribe or dispense a particular drug without the need for an additional degree or medical specialty?

Mr. ENZI. Yes. This is the intent.

Ms. MURKOWSKI. And under the provisions of section 202, would the willing health care provider be able to receive this training or certification through remote learning methods so that a provider would not need to travel vast distances in order to get the requisite training?

Mr. ENZI. Yes. The language in the bill recognizes that travel in frontier areas, particularly in remote places such as Alaska, can be time-consuming and expensive, so it specifically notes that the training or certification should be available in a widely available training or certification method, such as an online course or through the mail. This is intended to reduce the amount of travel and expense a willing provider in a frontier area must undertake in order to be able to prescribe or dispense needed medicines to their

Ms. MURKOWSKI. I thank the Senator. And since the provider would not be required to obtain an additional degree or medical specialty, and the training or certification would hopefully be through an online course or through the mail, is there any indication of how long such training would take for the provider to be deemed sufficiently trained to prescribe a specific drug?

Mr. ENZI. While I cannot give the Senator a guaranteed time frame, I would point out that the training and certification is specifically for the drug the provider is seeking to prescribe or dispense--not for a range of drugs. Thus, the time frame should not be a lengthy one, particularly if the training can be conducted online.

Ms. MURKOWSKI. Now, I understand that many physicians around the country are invited to attend conferences or training seminars in order to be certified to prescribe certain drugs. Given the low volume of the high risk drugs we are talking about that are likely to be dispensed in frontier areas, how can we ensure that a willing provider will be able to access this training? What is the incentive for a drug manufacturer or the FDA to include frontier area among the areas where training and certification would be available?

Mr. ENZI. I thank the Senator for that question. The language in the bill specifically says that the training or certification shall be available to any willing provider from a frontier area. Shall be available--not may be available, but shall. It is the intent of Congress in this section to direct the FDA to guarantee that a willing provider will have access to the training and certification needed to prescribe a particular drug. And again, the language that encourages the availability of an online course or course through the mail is one way to provide for that training or certification at minimal cost.

Ms. MURKOWSKI. I thank the Senator for that clarification. I bring this colloquy to the Senate floor today because I want to ensure that every
American has access to prescription drugs regardless of whether they live in a large urban city like New York, or a frontier community like Bethel, AK. I believe that with the modifications that have been made to this bill, we will be able to achieve that.

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