Medco and FDA to study role of genetic tests

John Carroll — Tue, 19 Aug 2008 08:09:32 -0400

The pharmaceutical benefits manager Medco Health Solutions is partnering with the FDA to examine how genetic testing is coming into play to determine the right drug or dose for a patient. Mining its massive database of claims, Medco will examine whether doctors are willing to use new genetic tests to adjust the dosages that are prescribed to patients as part of a broader exploration of the role of pharmacogenomics in the clinical setting.

This kind of collaboration is considered another significant step down the road to personalized medicine, when a person's genetic profile will determine the therapy and dose needed to treat an ailment. And the FDA wants to know more about the barriers that are likely to slow this trend down along the way.

"We're all about making this field happen as fast as it appropriately should happen," Medco's chief medical officer, Robert Epstein, told the Wall Street Journal.

--see the Medco release
--read the report from the Wall Street Journal

FDA to address nanotech standards

Maureen Martino — Thu, 26 Jul 2007 15:19:46 -0400

Nanotechnology has enormous potential to revolutionize the drug, medical device, cosmetic and food industries, but according to a new report, the FDA lacks a standard regulatory procedure for approving nanotech products. Hundreds of nanotech products are already on the market, yet the long-term effects aren’t fully understood and could be hazardous. Nanoscale materials often have chemical, physical, or biological properties that are different from those of their larger counterparts and there is a critical need to ensure that these new technologies work as intended without any unforseen consequences.

Last August the FDA created a task force to advise the agency on nanotech products to boost the agency’s oversight of the technology. The members of the task force were to recommend ways to fill any policy or knowledge gaps in the field, with a particular focus on any health threats that could be posed by the science of the very small. Now the FDA’s Nanotechnology Task Force has concluded that the agency doesn’t have the expertise, tools or regulatory pathways needed to assess the impact of nanotech drugs and medical devices on human health. In order for nanotechnology to safely achieve its potential, the task force recommends that the FDA adopt guidance for manufacturers and researchers that "ensur[e] transparent, consistent, and predictable regulatory pathways." This means beefing up the FDA’s in-house expertise on the subject. Additionally, the agency needs to examine whether the tools available to describe and evaluate nanoscale materials are sufficient, and to develop additional tools where necessary.

"Nanotechnology holds enormous potential for use in a vast array of products," said Commissioner of Food and Drugs Andrew von Eschenbach, M.D. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.

- see the press release for a summary
- read the FDA report on nanotechnology

More nanotech news

> FDA gathers expert advice on bionanotech

> The risks and rewards of nanotechnology

> Nanodevice used to detect response to therapeutics

> Nanotech grows more common in drug dev research

> Nanomaterials used to fix neuron damage

> Nanoparticle developed for new drug delivery system

> Hot nanoprobes used to slow tumor growth in animals

> Super-thin membrane advance protein revolution

> Nanoparticles used to destroy tumors

FDA news

Medco and FDA to study role of genetic tests

FDA to address nanotech standards