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Tag Archives: FDA

International Center for Technology Assessment et al v. Hamburg

On December 21, 2011, the International Center for Technology Assessment (ICTA), along with fellow plaintiffs Friends of the Earth (FOE), the Center for Environmental Health, Food and Water Watch, the Institute for Agriculture and Trade Policy, and the Action Group on Erosion, Technology and Concentration filed a complaint in the US District Court for the District of Norther California against Margaret A. Hamburg, Commissioner of the US Food and Drug Administration (FDA), requesting that "this Court enter an Order:

 

(1) Declaring that the Defendants have violated the Administrative Procedure Act by failing to respond to the 2006 Petition within a reasonable time;

(2) Declaring that the Defendants continue to be in violation of the Administrative Procedure Act by failing to respond to the 2006 Petition;

(3) Ordering Defendants to respond to the 2006 Petition as soon as reasonably practicable"

In May of 2006, ICTA filed a "Petition Requesting FDA Amend Its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically". The petition requested "that the Commissioner undertake the following actions with regards to all nanomaterial products:

1) Amend FDA regulations to include nanotechnology definitions necessary to properly regulate nanomaterial products . . . .

2) Issue a formal advisory opinion explaining FDA’s position regarding engineered nanoparticles in products regulated by FDA.

3) Enact new regulations directed at FDA oversight of nanomaterial products establishing and requiring . . .that: nanoparticles be treated as new substances; nanomaterials be subjected to nano-spefic paradigms of …

FDA Public Workshop on Medical Devices & Nanotechnology

Monday’s federal register carried a notice from the Food & Drug Administration (FDA) announcing a public workshop on "Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations" to be held September 23 2010, from 8AM to 5PM at the Hilton Washington DC/North Gaithersburg, in Gathersburg, MD. Persons interested in participating in the workshop need to register by September 15, 2010. The notice provides a link and details on how to register. If anyone wishes to make an oral presentation during the workshop sessions, that needs to be indicated at the time of registration.

According to the notice

The objective of this public workshop is to obtain information on manufacturing, characterization, and evaluation of biocompatibility of medical devices containing or utilizing nanomaterials and nanostructures.

Issues for Discussion

    The workshop will focus on two topics: (1) Manufacturing and characterization of medical devices containing or utilizing nanomaterials or nanostructures; (2) biocompatibility evaluation of medical devices containing or utilizing nanomaterials or nanostructures. The discussion on manufacturing and characterization will include the evaluation of physico-chemical properties of nanomaterials or nanostructures, characterization methods required, device manufacturing processes and evaluation of the final processed device after sterilization, and stability and aging studies. The discussion on biocompatibility evaluation will include testing for potential release of nanomaterials and additional testing considerations other than standard testing methods to determine the biocompatibility and toxicity of devices containing or utilizing nanomaterials or structures.

Registrants for the workshop will be participate in the oral presentations discussed above and via two roundtable discussions between the FDA’s staff …

Reporting Format for Nanotechnology Related Information in CMC Review

Recently, the Center for Drug Evaluation and Research (CDER)  Office of Pharmaceutical Science issued the above entitled addition to CDER’s Manual of Policies and Procedures(MAPP). This produced some uproar in the nanotech community by some who interpreted a single line as indicating that the FDA was about to start redefining nanomaterials.

The purpose of this new MAPP is to provide "chemistry, manufacturing, and controls (CMC) reviewers within the Office of Pharmaceutical Sciences (OPS) with the framework by which relevant information about nanomaterial- containing drugs will now be captured in CMC reviews of current and future CDER drug application submissions. This information will be used to develop policy regarding these products."

In its background section, the MAPP notes that "because development of nanotechnology based drugs is still in its infancy, there are no established standards for the study or regulatory evaluation of these products."  (Emphasis added). The MAPP then goes on to define nanomaterials/nanoscale materials as "any materials with at least one dimension smaller than 1,000 nm".

What is important to note here is the language contained in a footnote: "The definations described in this section apply only to this MAPP". (Emphasis added). This defination, in short, doesnot apply outside of the manual. While the accepted defination of nanomaterials is that of any material at smaller than 100 nm, there is currently no legal defining of nanomaterials. Title I Section 102 of H.R. 5116,  The America COMPETES Reauthorization Act of 2010 would define "nanoscale" as meaning "one or more dimensions of between approximately 1 and …

New Edition of Nanotechnology Law Report

Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

  • EPA Issues Significant New Use Rules for Carbon Nanotubes
  • Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
  • Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
  • Are Nano Consumer Products Headed Underground?
  • Oversight of Next Generation Nanotechnology
  • Regulating Nanotechnologies
  • More Interesting Nano-Regulatory Developments
  • Nano Tug of War
  • Pumpkins & Nanoparticles
  • Green Nano
  • NanoBiotech 2009
  • Take two silver nanoparticles and call me in the morning
  • International Approaches to the Regulatory Governance of Nanotechnology
  • ETUC Resolution on Nanotechnologies and Nanomaterials
  • Private Spending on Nano Exceeds Government Spending
  • EMERGNANO Released

FDA Announces Collaborative Effort with Alliance for Nanohealth

 Last week the FDA posted a press release on the news section of FDA.gov announcing a "collaboration initiative" with the Alliance for Nanohealth (www.nanohealth.org) . The press release may be accessed at http://www.fda.gov/bbs/topics/NEWS/2009/NEW01971.html. FDA and ANH will work together "to expand knowledge of how nanoparticles behave and affect biologic systems  and to facilitate the development of tests and processes" to lower possible risks that might be associated with nanoengineered products.

The "Memorandum of Understanding" (MOU) between FDA and ANH, published in the Federal Register 03/13/2009 (72 FR 10927), makes it clear that this collaboration has two major goals:

1) "Moving nanoengineered medical products from the preclinical stages of development through clinical stages and then to commercialization."

2) "Understanding the risks and benefits of nano-engineered medical product development to the extent that this information can faciliatate the regulatory review and evaluation of new medical products that incorporate nanotechnology."

The MOU can be found at http://www.access.gpo.gov/su_docs/fedreg/a090313c.html

FDA Public Meeting to Discuss Task Force Report

The Food and Drug Administration has announced its next public meeting to discuss the results of the Nanotechnology Task Force report.  The meeting is September 8, and any comments on the Report are due by August 24.  The meeting will be held at University Systems of Maryland.

The meeting agenda is posted online, and the session to begin at 8:30 and conclude by 5:00.  In addition, the FDA has listed several product specific questions to be discussed during the breakout sessions.  Those questions are listed after the jump…

Confusion at the FDA

FDA Week is reporting that a meeting at the Food and Drug Administration late last month failed to result in any agreement about a possible policy on nanomaterials.  The FDA Nanotechnology task force met on July 22, 2008 to consider the creation of a policy for nanomaterials, but failed to come to any consensus on whether one should be drafted, let alone the contents.…

Recommendations for New Nano-Specific Regulation

As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.

J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008. Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.

TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.

FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information.  He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic."  Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale …

New York Times Editorial On FDA

This morning’s New York Times features an editorial discussing Peter Barton Hutt’s before the House subcommittee responsible for FDA oversight.  Mr. Hutt warned that the FDA was "barely hanging on by its fingertips;"  others testifying before the subcommittee suggested the agency lacked funds and staffing to do its job:

In a hearing before a House Energy and Commerce subcommittee, members of the agency’s own scientific advisory board outlined the F.D.A.’s many weaknesses. It lacks scientists who understand rapidly emerging technologies — including genomics and nanotechnology — relevant to product safety. The agency is further hobbled by a high turnover rate of scientists, a decrepit information technology system, a weak organizational structure, and a shrinking inspection force.

That said, FDA has been researching nanotechnology issues for some time — it formed its Nanotechnology Task Force in August 2006.   Still, it’s interesting that nanotechnology safety issues have even found their way to the editorial page of the New York Times.…

FDA Regulation of Nanotechnology?

By Tim Cahill:

Yesterday the FDA’s Nanotechnology Task Force released its report on the scientific and regulatory challenges related to the use of nanotechnology in products regulated by the FDA. As reported in our July 10, 2007 post, the Task Force’s report did not call for additional FDA regulatory authority in this area. The Task Force concluded that the use of nanomaterials in products regulated by the FDA presents challenges similar to those products using existing technologies and other emerging technologies. Further, the Task Force determined that the current science on nanotechnology does not suggest that products using nanomaterials require additional labeling. …

No Nano Regulation by FDA?

By: Tim Cahill and Michael Heintz:

FDA Week reported on July 6, 2007 that the FDA’s Internal Nanotechnology Task Force is close to issuing its first report and is going to recommend that the agency not create "regulatory policies" for nanomaterials.  Instead, the task force is likely recommending that FDA create guidelines for "best practices."  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits. 

FDA Week also observes that an agency official stated as early as 2005 that the agency would not regulate products containing nanotechnologies any different than conventional products, and "The agency does not regulate the technology as a separate entity so products such as drugs or medical devices that employ nanotechnology are scrutinized while cosmetics are not. "  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits. …

Former FDA Official Calls for Increased FDA Nanotech Authority

By Tim Cahill:

The April 20, 2007 edition of FDA Week reports that the former deputy commissioner in the FDA’s policy office, Michael Taylor, repeated his call for Congress to grant FDA enhanced regulatory authority with respect to products that utilize nanotechnology, particularly cosmetics, dietary supplements, and foods.

Mr. Taylor believes that FDA should have the authority to force companies to disclose information about the nanotechnology they use in these products so the agency can better monitor the associated risks. Mr. Taylor made this assertion while speaking at a Food and Drug Law Institute conference on April 12th, and he initially raised this issue in a report he wrote last October for the Wilson Center’s Project on Nanotechnology entitled "Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?"

 …

New Report Warns of Nanotechnology Risks in Cosmetics

By Tim Cahill:

On February 20, 2007, the Investor Environmental Health Network ("IEHN") issued a report entitled "Beneath the Skin: Hidden Liabilities, Market Risk and Drivers of Change in the Cosmetics and Personal Care Products Industry." IEHN represents 20 investment organizations with $22 billion under management that are seeking to ensure that the companies they invest in are taking appropriate steps to reduce risks associated with the toxic chemicals used in their products. The IEHN’s report warns that nanotechnologies represent one of the significant health risks in the cosmetics industry and that investors in this industry must be aware that sweeping changes are likely to occur in this market. The report describes the Food and Drug Administration’s ("FDA") current oversight of cosmetics as a "a porous and ill-defined regulatory framework" and cites to the fact that "cosmetics are generally exempt from pre-market review" as a major limitation in the FDA’s ability to regulate cosmetics. As a result, the report recommends that cosmetics manufacturers take independent steps to monitor the safety of their products in order to avoid potential liability and gain a competitive advantage by increasing their brand trust.…

Report by Former FDA Official Urges Greater Regulation of Nanoindustry

An October report authored by Michael R. Taylor, Esq., former FDA Deputy Commissioner for Policy (1991-1994) may not be warmly received by all nanomanufacturers. Taylor’s report focuses on what he sees as FDA’s three primary purposes in relation to nanotechnology: (1) ensure product safety; (2) foster innovation; and (3) maintain public confidence in nanoproducts.  Taylor analyzes existing FDA pre-market review and post-market monitoring powers over nanotechnology products and finds several insufficiencies.…

Review: “Nanotechnology and the FDA,” in Nanotechnology Law & Business

In the September 2006 edition of Nanotechnology Law & Business, two (2) employees of FDA’s Center for Drug Evaluation and Research (“CDER”) — Nakissa Sadrieh and Parvaneh Espandiari — published “Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?”

The article begins with a disclaimer that the authors’ views and opinions are not necessarily those of FDA, and then narrows its specific focus to nano-products regulated by FDA’s Center for Drug Evaluation and Research (‘CDER’) – primarily new drugs and/or drug delivery systems. …

Expert Says FDA Should Ensure Capacity to Address Nanoapplications

In a recent presentation to FDA, David Rejeski, Director of the Woodrow Wilson Center’s Project on Emerging Nanotechnologies, stated “there are currently 130 nano-based drugs and delivery systems and 125 biomedical devices in preclinical, clinical or commercial development.”  Of these, Rejeski identified 77 cancer-related drugs and 56 drug delivery applications.  Rejek also stated that the “stakes are extremely high” in the nanotechnology industry, and that FDA should ensure it has the “capacity to address potential nanotechnology risks now” in order to maintain public confidence. Lab Business Week, November 12, 2006.  …

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