FDA Works to Speed the Advent of New, More Effective Personalized Medicines

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FDA Works to Speed the Advent of New, More Effective Personalized Medicines

As part of an agency-wide initiative to speed development of new medical

products through the science of pharmacogenomics, the Food and Drug

Administration (FDA) today issued a final guidance titled " Pharmacogenomic

Data Submissions. "

Pharmacogenomics allows health care providers to identify sources of an

individual's profile of drug response and predict the best possible

treatment option for this individual. For example, genomic tests are helping

to identify cancers that have a good chance of responding to a particular

medication or regimen. This technology has enabled the development of

targeted therapies like Herceptin for metastatic breast cancer, Gleevec for

chronic myeloid leukemia and Erbitux for metastatic colorectal cancer.

" FDA's efforts will bring us one step closer to 'personalizing' medical

treatment, " explained Dr. Janet Woodcock, Deputy Director for Operations,

FDA. " This new technology will allow medicines to be uniquely crafted to

maximize their therapeutic benefits and minimize their potential risks for

each patient. "

Instead of the standard hit-or-miss approach to treating patients, where it

can take multiple attempts to find the right drug and the right dose,

doctors will eventually be able to analyze a patient's genetic profile and

prescribe the best available drug therapy and dose from the start. Both the

guidance and a new Web page are part of a broad effort underway at FDA to

foster pharmacogenomics during drug development.

FDA also recently approved the first laboratory test, the Amplichip

Cytochrome P450 Genotyping Test, which will enable physicians to use genetic

information to select the right doses of certain medications for cardiac,

psychiatric diseases and cancer.

" We hope ultimately to bring pharmacogenomics, a way in which to foster the

personalizing of medicine, to every healthcare professional's prescription

pad for the benefit of their patients and U.S. consumers, " said Dr.

Woodcock.

The guidance " Pharmacogenomic Data Submissions, " clarifies how

pharmacogenomic data will be evaluated. The final guidance describes what

data will be needed during the marketing application review process, the

format for submissions, and the data that will be used during regulatory

decision making. The guidance also explains a new mechanism for industry to

voluntarily submit research data to further the scientific exchange of

information as we move into more advanced areas of pharmacogenomic research.

The voluntary data, which will be reviewed by an internal, agency-wide group

and will not be used for regulatory decision making, will help FDA and

industry gain valuable experience as this new field continues to evolve.

FDA believes this approach will save time and resources and eliminate

possible delays in the application review process because parties will be

able to familiarize themselves with novel pharmacogenomic approaches as they

evolve.

FDA's new pharmacogenomics Web page is available at

http://www.fda.gov/cder/genomics/default.htm. The Web site ( " Genomics at

FDA " ) will be useful to industry because it includes detailed information on

submitting genomic data, including a decision tree to simplify data

submissions, relevant regulatory information, and FDA contact information.

FDA has already received several pharmacogenomic data submissions through

both the regulatory and voluntary processes and will continue to work

closely with industry and the healthcare community on this exciting emerging

technology.

In addition to announcing the availability of its final guidance and the new

pharmacogenomic Web page, the agency also reminded the public of the April

11 to 13 meeting being held at the tt Hotel in Bethesda , MD on

pharmacogenomics issues. The meeting is being sponsored jointly by FDA and

the Drug Information Association. The joint FDA/DIA meeting,

" Pharmacogenomics in Drug Development and Regulatory Decision Making " will

focus on integrating pharmacogenomics in clinical trials for new drugs,

biologics, and associated devices. FDA will also address ways to translate

pharmacogenomics into medical product development and clinical practice.

On April 26th at 1:00 p.m. at the Washington Convention Center , the FDA

will be presenting a symposium for the public entitled " Personalizing your

Healthcare: The Best Consumer is an Educated Consumer. " This free session

will allow members of the general public the opportunity to hear about the

science behind personalized medicine, an issue of critical importance to

both consumers and FDA. Presentations will be from experts in the field and

there will be time for questions. For more information, please go to:

http://www.fda.gov/scienceforum; for public session:

http://www.cfsan.fda.gov/~frf/forum05/pubsci.html.