2004N-0221 - Medicare Modernization Act Section 107(f) - Study on Making Prescription Pharmaceutical Information Accessible for Blind and Visually-Impaired Individuals; Establishement of Docket
FDA Comment Number : EC12
Submitter : Mr. Jerry Mahoney Date & Time: 07/07/2004 06:07:04
Organization : iVoice, Inc.
Private Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL

June 16, 2004


FOOD & DRUG ADMINISTRATION
Division Of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD. 20852


RE: Medical Prescription Drug, Improvement and
Modernization Act of 2003- Blind and Visually Impaired Study

Dear FDA Officials;

iVoice has become a leader in the speech recognition application development market. iVoice, Inc., designs solutions to business problems using its expertise in speech development tool and building speech based applications for the telephony markets. iVoice Inc. has achieved global recognition because of its expertise with speech recognition through the telephone. iVoice Inc., achievements have lead to increasing opportunities in both the government and commercial sectors. iVoice also develops but does not produce, voice-related technologies for medicine compliance, as well as for other products and services that may be enhanced by voice recognition and/or voice producing technology.

The basic usage under the new patent application will allow pharmacists to simply take a medication bottle and wave or run it by a designated PC. That PC, via wireless technology, will automatically download the appropriate talking prescription instructions to the pill bottle. This information comes from either what the pharmacist has typed into the computer, via text to speech, or from an existing database of instructions for the prescribed medication prepared by the pharmaceutical manufacturer. When a person cannot read or understand the label on a medication bottle, errors in use can occur. The resulting errors can range from unfavorable reactions that are simply uncomfortable to untimely death. In particular, the elderly and people with visual and other disabilities have faced serious medical emergencies because they were unable to read the labels or instructions on their medications. When it's time to take the prescription, the patient simply presses a built-in button on the medication bottle to hear the message and instructions.

In response to your request to iVoice regarding the above, we are providing the following information and thoughts, with the sections and
numbered paragraphs corresponding to your numbered sections and paragraphs: