[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56769-56770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0356]


Behind the Counter Availability of Certain Drugs; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice of public meeting; request for comments.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a public 
meeting to obtain comments regarding behind-the-counter (BTC) 
availability of drugs. Currently, drugs are available as prescription 
and non-prescription. Generally, non-prescription products are 
available in an ``over-the-counter'' (OTC) manner. The FDA is 
interested in obtaining public comment as it explores the public health 
benefit of certain drugs being available without a prescription but 
only after intervention by a pharmacist. The purpose of the meeting is 
to solicit information and views from interested persons on specific 
issues associated with BTC availability, including the impact on 
patient access to safe and effective drug products.
    Dates and Times: The public meeting will be held on November 14, 
2007, from 8 a.m. to 5 p.m.
    Location: The public meeting will be held at the National 
Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW., 
Washington, DC 20594.

ADDRESSES: Submit written registration and written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
registration to http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
    Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. Transcripts of the meeting will 
be available for review at the Division of Dockets Management and on 
the Internet at http://www.fda.gov/ohrms/dockets approximately 30 days 
after the meeting.
    For Registration to Attend and/or Participate in the Meeting: 
Seating at the meeting is limited. People interested in attending 
should submit written or electronic registration to the Division of 
Docket Management (see ADDRESSES) by close of business on November 5, 
2007. Registration is free and will be on a first-come, first-serve 
basis. Written or electronic comments will be accepted until November 
28, 2007.
    If you wish to make an oral presentation at the meeting, you must 
state your intention on your registration submission (see ADDRESSES). 
To speak, submit your name, title, business affiliation, address, 
telephone number, fax number, and e-mail address. FDA has included 
questions for comment in this notice. You should also identify by 
number each question you wish to address in your presentation. FDA will 
do its best to accommodate requests to speak. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their presentations, and to request time for a joint 
presentation. FDA will determine the amount of time allotted to each 
presenter and the approximate time that each oral presentation is 
scheduled to begin.
    If you need special accommodations due to a disability, please 
inform Erik Mettler (see For Information on the Meeting Contact).
    For Information on the Meeting Contact: Erik Mettler, Office of 
Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, rm. 
14-101, Rockville, MD 20857, 301-827-3360, FAX: 301-594-6777, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to ensuring the safety and efficacy of all drug 
products it regulates. FDA is exploring the public health benefit of 
certain drugs being available BTC that were previously prescription 
medications. BTC could be comprised of certain medications available 
behind the counter at the pharmacy without a prescription and require 
the intervention of a pharmacist before dispensing.
    Some groups have asserted that pharmacist interaction with the 
consumer could ensure safe and effective use of a drug product that 
otherwise might require a prescription. Because pharmacists have the 
training and knowledge to provide certain interventions, they may be 
able to ensure that patients meet the conditions for use and educate 
patients on appropriate use of the drug product. These groups have 
suggested, moreover, that the availability of certain drugs BTC could 
increase patient access to medications that may be underutilized, 
particularly by patients without health insurance because these 
medications otherwise would be available only with a prescription.
    Variations of a BTC status are already in effect in other 
countries, including Australia, Canada, France, New Zealand, United 
Kingdom (UK), Denmark, Germany, Italy, Netherlands, Sweden, and 
Switzerland. In the UK, there is a ``pharmacist-only'' class of drugs, 
while the other countries have more than three classes. In general, 
foreign countries have used the following criteria for switching a drug 
from prescription to intermediate class: (1) Indications suitable for 
self-medication, including self-diagnosis, with the intervention of a 
pharmacist and (2) the medicine has a low potential for side effects or 
overdose, and intervention by a pharmacist could minimize these risks. 
Other considerations include: Abuse potential, patient choice and 
accessibility, and public health issues. With the pharmacy-only 
classification, typically the pharmacist is required to ensure the 
patient meets certain criteria prior to dispensing, as well as to 
provide education on proper use and monitoring.
    Accordingly, FDA is interested in exploring the public health 
implications of BTC dispensing of certain drug products, including 
(among other things) the implications for patient access and 
utilization, including drug prices, the continued safety and 
effectiveness of drugs, and patient compliance with drug therapy.

II. Scope of Meeting

    FDA is interested in obtaining public comment on BTC availability 
of certain drugs, the appropriate regulatory

[[Page 56770]]

framework for such drugs, and criteria for BTC availability.
    Specifically, we are seeking input on the following issues related 
to BTC:
    General
    1. Should there be BTC availability of certain drug products? If so 
why? If not why?
    2. What might the impact of BTC be on patient access?
    3. What might the impact of BTC be on patient compliance with drug 
therapy?
    4. What should the criteria or standards be for a drug to be 
treated as BTC?
    5. Please comment on the following criteria for what roles a 
pharmacist or other health professional might play, which are included 
below for discussion purposes. For example, a pharmacist or other 
practitioner licensed by law to dispense prescription drugs prior to 
sale might:
    (A) Review or conduct an initial screening for clinical laboratory 
test results, contraindications, or drug interactions;
    (B) Counsel the patient on safe use;
    (C) Monitor for continued safe or effective use.
    6. Should BTC availability be used as a temporary or transitional 
status for drugs that move from prescription status to OTC versus a 
permanent status?
    7. Should there be criteria or standards for a drug to transition 
out of BTC status to OTC status? If so, what should these criteria or 
standards be?
    8. If safety concerns arise, should there be criteria or standards 
for a drug to transition out of BTC status to prescription status? Or 
from OTC status to BTC status? If so what should these criteria or 
standards be for each scenario?
    9. What effect would BTC availability have on patient access to 
medications in this category?
    10. How could we evaluate whether BTC improves patient access to 
medications?
    11. Would BTC availability be cost-effective to patients? Please 
explain.
    12. What effect would BTC availability have on patient safety?
    13. What measures would be necessary to ensure patient safety?
    14. In general, what are the benefits and costs to the healthcare 
system as a whole related to BTC availability?
    Logistics
    1. Discuss logistical challenges for pharmacy storage and 
dispensing of BTC drugs. How might these challenges be addressed?
    2. What dispensing procedures should be associated with BTC 
medications?
    3. What types of records should be kept in association with BTC 
dispensing? If such records were to include patient laboratory values, 
how would the pharmacist gain access to this information as well as 
other information in the patient's medical records?
    4. How would patient privacy be protected in a retail pharmacy 
setting? Please discuss any privacy concerns that would need to be 
addressed.
    5. Should reimbursement be available to pharmacists for providing 
services associated with BTC dispensing? What type? What type of 
billing procedures could be utilized and how would third party 
companies facilitate such reimbursements?
    6. Who would oversee a BTC program? What impact would it have on 
States and what might be the role for the State boards of pharmacy?
    7. Would special training be needed for pharmacists to participate 
in dispensing BTC medications? If any, what type of training would this 
entail?
    8. Would special training be needed for other pharmacy staff to aid 
in managing the work flow (storage, record keeping, distribution) and 
additional BTC responsibilities of the pharmacist(s) and the pharmacy? 
If so, what type of training or measures should be put in place?
    9. Could qualified healthcare professionals/providers other than 
pharmacists be responsible for dispensing of BTC drugs? If so, what 
types of healthcare professionals/providers? And in what type of 
settings could this situation be accommodated?
    10. What impact would BTC availability of drugs have on the 
practice of pharmacy?
    11. What impact would BTC availability of drugs have on the 
practice of medicine?

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic notices of participation and 
comments for consideration. To permit time for all interested persons 
to submit data, information, or views on this subject, the docket for 
the meeting will open 14 days prior to the meeting and remain open for 
30 days following the meeting. Persons who wish to provide additional 
materials for consideration should file these materials with the 
Division of Dockets Management. You should annotate and organize your 
comments to identify the specific questions identified by the number 
and subject to which they refer in the previous text in this document. 
Please identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. Transcripts of the meeting also will be available for 
review at the Division of Dockets Management.

    Dated: September 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19329 Filed 10-3-07; 8:45 am]
BILLING CODE 4160-01-S