Nanotechnology Challenges FDA and Manufacturers - Pharmaceutical Technology

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Nanotechnology Challenges FDA and Manufacturers
Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles.


Pharmaceutical Technology
Volume 32, Issue 11, pp. 36-44


Jill Wechsler
In the past three years, nanotechnology has gained prominence on the US Food and Drug Administration's regulatory and research agenda. The prospect that tiny materials may form effective, targeted medicines and improved versions of many FDA-regulated products has generated great enthusiasm among scientists and manufacturers. Some drugs that incorporate nanomaterials are already on the market, along with many over-the-counter sunscreens, cosmetics, dietary supplements, and food products.

Nanotechnology will be used in many products that come across FDA's threshold, according to the agency's senior scientist Richard Canady. FDA's challenge, Canady explained at a public meeting on nanotechnology in September 2008, is to determine whether products incorporating small particles pose new hazards and thus require new regulatory and testing policies.

Uncertainties about how nanoscale materials may affect the human body and the environment has prompted calls for more analysis of possible toxicities and more scrutiny of unanticipated effects. Sunscreens with nanoparticles appear to offer better protection from harmful rays, but raise concerns about particle absorption into the body, as well as emission of nanomaterials into the air and water. And little is known about whether ingestion of dietary supplements, food products, and medicines made or packaged with nanomaterials will affect individuals.

Although scientific evidence does not indicate that nanoscale particles are inherently toxic, most experts don't assume a product is safe based on evidence from conventional versions of a material. FDA has been grappling with these safety issues for several years and continues to weigh whether nanotechnology can be regulated under existing rules and authorities. A related question is whether new requirements are needed for all nanomaterials or for certain subgroups of products using this technology.

FDA moved to address these concerns formally when the International Center for Technology Assessment and a consumer coalition filed a petition in 2006 that cited the agency's failure to regulate health threats from nanomaterials, particularly from the rising number of nanosunscreens then proliferating on the market. The agency formed a task force and held a public meeting in October 2006 to discuss the need for stricter nanotechnology-product regulation. This led to a report in July 2007 that outlined the scientific and regulatory challenges for FDA oversight of the expanding nanotechnology world.


In Washington This Month
The report recommended that FDA evaluate the adequacy of testing approaches to ensure the safety, efficacy, and quality of nanoscale materials in regulated products. The task force said that FDA should weigh the need for new data-characterization methods, standards for nanoscale materials, and for a better understanding of how nanomaterials relate to one another. The panel also emphasized that FDA should build its in-house expertise to ensure it can keep up with new scientific developments in this field. And manufacturers should better inform FDA reviewers about what is known about a nanoproduct and what analysis has been performed, the panel said.

No new regulations

The report stopped short, however, of recommending new regulatory action, citing little evidence that nanoscale materials are inherently hazardous. Instead of requiring companies to submit manufacturing and safety information for all products with nanomaterials to the agency and to disclose the presence of such materials on product labels, as advocated by some experts and consumer groups, the report recommended addressing disclosure and data issues on a product-by-product basis.

FDA officials explained that the agency may not need added authority to ensure the safety of nanomaterials in drugs and other medical products that already require premarket review. Instead, the agency should issue guidance recommending how and when sponsors should identify particle size in submissions. For products with varying premarket-data submission requirements, such as medical devices, dietary supplements, and over-the-counter drugs, new guidance could clarify when FDA should request particle-size data. Manufacturers are responsible for the safety of these products, noted Canady, but the presence of nanoscale materials in such products, he said, "may in fact change regulatory status."

Former FDA official Michael Taylor, who works with the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center (Washington, DC), says that FDA may need additional authority to obtain safety information about products that include nanomaterials, particularly cosmetics and dietary supplements not normally reviewed by the agency before entering the market. He also urges lawmakers to provide the agency with added resources to support research on nanomaterials and to build up agency expertise to make FDA "nanoready."

At a nanotechnology conference in February 2008, sponsored by the Food and Drug Law Institute (FDLI), Taylor warned that a safety problem involving a product with nanotechnological materials not subject to premarket review "will set back public confidence and acceptance of nanotech products generally." And public fears about nanoproducts, along with unresolved scientific and safety issues, "will slow or block market access for innovative products," he predicted.

At the same time, Taylor and other experts raise concerns that overregulation could discourage innovation that might lead to valuable advances in biomedical research and development. At the July 2008 meeting of FDA's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, Keith Webber, deputy director of the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER), noted a need to "filter out the hype" about the safety of products containing nanoparticles so that FDA can establish an appropriate regulatory process. The hope is, Webber commented, that nanoscale materials may lead to targeted therapies with reduced systemic exposure in patients, to novel dosage forms with sustained release, and to products less likely to degrade over time.


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