International Center for Technology Assessment et al v. Hamburg

Posted on January 6, 2012 by Robert Oszakiewski

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 health and safety testing; and that nanomaterial products be labeled to delineate all nanoparticle ingredients

4) Any currently existing or future regulatory FDA programs for nanomaterial products must comply with the requirements of the National Environmental Policy Act (NEPA) including . . . that FDA conduct a Programmatic Environmental Impact Statement (PEIS) reviewing the impacts of nanomaterial products on human health and the environment.

Petitioners request that the Commissioner undertake the following actions with regard to nanomaterial sunscreen drug products:

5) Reopen the Administrative Record of the Final Over the Counter (OTC) Sunscreen Drug Product Monograph for the purpose of considering and analyzing information on engineered nanoparticles of zinc oxide and titanium dioxide currently used in sunscreens.

6) Amend the OTC Sunscreen Drug Monograph to address engineered nanoparticles, instructing that sunscreen products containing engineered nanoparticles are not covered under the Mongraph and instead are "new drugs" for which manufacturers must complete a New Drug Application. . . .

7) Declare all currently available sunscreen drug products containing engineered nanoparticles of zinx oxide and titanium dioxide as an imminent hazard to public health and order entities using the nanoparticles in sunscreens regulated by FDA to cease manufacture until FDA's Sunscreen Drug Monograph is finalized and FDA nanotechnology regulations are developed and implemented.

8) Request a recall from manufacturers of all pulically available sunscreen drug products containing engineered nanoparticles of titatium dioxide and/or zinc oxide until the manufacturers . . .complete new drug applications, those applications are approved by the agency, and the manufactureres otherwise comply with FDA's relevant nanomaterial product testing regulations.

FDA held open meetings and established docket FDA -2006-P-0213 (two versions of this docket exist, on Regulations.gov and on the FDA's site). Comments were filed by various stakeholders between 2006 and 2009. Many of these comments, such as those submitted by Purest Colloids Inc and the Cosmetic, Toiletry and Fragrance Association (CFTA) severly criticized the ITCA's petition and urged the FDA not to take the actions requested in the petition.

In an interim response dated Nov. 9, 2006, Randall W. Lutter, then the FDA's Associate Commissioner for Policy and Planning noted that the

. . .FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by agency officials. . . . We will respond to your petition as soon as we have reached a decision on your requests.

Almost six years later, FDA is still in the process of formulating regulations and policy affecting nanotechnology and nanoindustry.

The parties in the case have been referred by the US Distirct Court to Alternative Dispute Resolution. We will continue to monitor the case and update as warranted.

UPDATE:

The parties in International Center for Technology Assessment et al v Hamburg, in a stipulation filed with the court on January 13, 2012, agreed  to grant the EPA " an extension of time to April 23, 2012 to answer, move, or otherwise respond to the complaint". EPA requested the extension "because defendent is working in good faith to respond to the citizen petition . . .on or before April 23, 2012."

As before, we'll keep monitoring and updating as warranted.

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FDA Public Workshop on Medical Devices & Nanotechnology

Posted on August 24, 2010 by Robert Oszakiewski

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 and "selected participants representing a range of constituencies."

For more information, the notice does provide a contact person:

Contact Person: Daya Ranamukhaarachchi, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5574, Silver
Spring, MD 20993, 301-796-6155, FAX: 301-847-8510, email:
Daya.Ranamukhaarachchi@fda.hhs.gov.
 

Considering that the workshop begins at 8AM hopefully there will be plenty of coffee.

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Reporting Format for Nanotechnology Related Information in CMC Review

Posted on June 21, 2010 by Robert Oszakiewski

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 100 nanometers".  HR 5116, discussed here earlier, has passed the House and awaits action in the Senate.

The remainder of the MAPP consists of informing OPS CMC reviewers of their responsibility for "correctly documenting nanotechnology related information in their reviews" and for presenting this information, which will cover such items as what nanomaterials are present in the drug, does the nanomaterial dissolve in water, etc,  in tabular form, which will be used later to populate the aforementioned database.

As as been noted here and in a variety of medical and science journals, nanotechnology's most immediate impact may be in the medical field, particularly in the treatment of cancer. The use of nanomaterials in medications and therapy is the latest development in the medical world and is fraught with controversy. By creating the database described in this MAPP, the FDA would be taking a first step towards fulfilling it's regulatory duty to the American public, by gathering information on which it can base later decisions and policies.

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FDA Announces Collaborative Effort with Alliance for Nanohealth

Posted on March 16, 2009 by Robert Oszakiewski

 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

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FDA Public Meeting to Discuss Task Force Report

Posted on August 18, 2008 by Michael E. Heintz

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

Product-Specific Questions to be Discussed at Nanotechnology Public Meeting: (taken from FDA website)

BREAKOUT SESSION: Medical devices, including diagnostics (discussion will include combination products)

  1. Are there general parameters or screening tools by which to evaluate the likelihood that a particular material might have nanoscale-specific properties and to decide when and what sort of further evaluation might be warranted? Are there characteristics and properties of materials that FDA can use to broadly categorize materials with respect to their likelihood of having nanoscale-specific properties warranting further review?
  2. What data and information should be considered in determining whether the presence of a nanoscale version of material in an existing device could affect the device's regulatory status, for example, in determining whether that device remains substantially equivalent to a predicate device?
  3. Do the existing Quality System Regulation requirements for process validation adequately address issues for manufacturing nanotechnology products, including issues related to demonstrating batch-to-batch reproducibility?
    (Product classification/combination product question)
  4. Do you believe that nanoscale products or products that contain nanoscale materials raise any novel questions relevant to their classification as biological products, devices, drugs, or combination products?  For instance, if an article achieves "its primary intended purposes through chemical action within or on the body of man or other animals" or is "dependent upon being metabolized for the achievement of its primary intended purposes," it can be a "drug" (including a drug constituent part of a combination product) but cannot be a "device" (including a device constituent part) (21 USC 321(h), 21 CFR 3.2). Do you believe that any nanoscale therapeutic articles, including constituent parts of combination products, interact with the body in ways that raise novel questions for determining whether the interaction should be viewed as a chemical action, as the article's being metabolized, or as some other form of interaction? Please provide examples to illustrate your views.

BREAKOUT SESSION: Prescription drugs, including biological, animal and over-the-counter (OTC) drugs (May include sunscreen)

  1. Are there general parameters or screening tools by which to evaluate the likelihood that a particular material might have nanoscale-specific properties and to decide when and what sort of further evaluation might be warranted? Are there characteristics and properties of materials that FDA can use to broadly categorize materials with respect to their likelihood of having nanoscale-specific properties warranting further review?
  2. What are the unique manufacturing features of products containing nanoscale materials and how should these be evaluated?
    • Is the manufacturing process understanding and development for nanoscale materials different from that of conventional drugs?
    • Does the use of nanoscale materials affect scale-up? If so, how?
    • If you develop a nanoscale material-containing product under the Quality by Design (QbD) paradigm, does this contribute to process understanding and manufacturing capabilities?
    • Can nanoscale materials affect product formulation, components, excipients, and processing?
  3. What are unique physicochemical attributes of products containing nanoscale materials?
    • How do they impact controls, standards, specifications, etc.?
    • How do they affect characteristics and performance of a product?
    • How do they complicate development and manufacturing of these products?
  4. What has been your experience to date with products containing nanoscale materials and/or have you avoided these products due to concerns about development, characterization, and manufacturing?
  5. What additional questions focusing on characterization and manufacturing aspects of products containing nanoscale materials should be addressed in this forum or brought to the attention of CDER?

BREAKOUT SESSION: Food and color additives, including food contact substances

  1. Can you identify specific classes of food ingredients or packaging components derived from or incorporating nanotechnology that you would identify as raising or not raising unique safety concerns and why?
  2. In your experience, what analytical methods and tools have proven to be of the most use to you in characterizing nanoscale materials? Looking to the future, can you suggest methods that might be developed or refined to augment those methods currently used?
  3. What physical characteristics of food-related nanoscale materials are of greatest concern regarding the safety of dietary consumption?
  4. Nanoscale food ingredients and food packaging may behave differently than macroscale materials. For example, nanoscale materials may agglomerate in food, interact with other components of the food matrix, and interact in the human body following ingestion. What methods are you using to characterize nanoscale materials in the food matrix and in the human body following ingestion?
  5. Are the current FDA Redbook toxicological endpoints and array of toxicity tests used for assessing the safety of macroscale food ingredients and packaging components sufficient to describe the toxicity of their nanoscale counterparts, or must new endpoints and assays be considered? Are you aware of any other toxicity tests not presently in wide use that may be more suitable? Are there toxicity tests that could be used to bridge data on macroscale ingredients to their nanoscale counterparts?
  6. Is nanotechnology applied to food ingredient and food packaging production primarily to create new effects for such compounds or to enhance existing effects? What are the perceived impacts on regulatory status or good manufacturing practice in each of these scenarios?
  7. How can FDA better communicate issues of regulatory status and safety of food ingredients and packaging components derived from nanotechnology to the public and industry?

BREAKOUT SESSION: Dietary supplements

  1. What data are there on whether nanoscale versions of common low solubility salts of dietary ingredients have new properties or characteristics?
  2. Would additional absorption, distribution, or safety data be needed to demonstrate the safety of a nanoscale version of an existing dietary ingredient?
  3. What data and information should be considered in determining whether a nanoscale version of an existing dietary ingredient is a new dietary ingredient?

BREAKOUT SESSION: Cosmetics

  1. What characteristics or types of nanoscale materials would be important to specify when considering potential risks of cosmetic products.
  2. If your company markets a cosmetic product with nanoscale particles, what function do they perform, at what concentration are they used, and how stable are they in the formulation?
  3. What, if any, additional studies are done for a product containing nanoscale particles to prove that this type of formulation is safe? What differences in safety or absorption have you observed between products formulated with nanoscale particles versus those that are formulated with [macroparticles] non-nanoscale materials?
  4. Are safety assessments being done at the bulk ingredient level or final formulation or both? How do these assessments differ?
  5. What is the effect on bioavailability of making larger particles nanoscale? Would you expect to see increased absorption/toxicity?

 
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Confusion at the FDA

Posted on August 7, 2008 by Michael E. Heintz

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.

The primary disagreement appears to be whether to issue a policy at all, or rely on existing statutory and regulatory controls.  As one might expect, the panel was split on this issue, resulting in no action in the short term.  The split was right down the middle with 5 panel members voting in favor of a policy, 5 voting against, and 1 abstaining.

The panel did agree that FDA should collaborate with OSHA and EPA should either agency begin drafting a policy concerning nanoparticles.  FDA will hold a public meeting in September to discuss particle size in drugs and how to obtain such information from its current database.

FDA's inaction is not wholly surprising given the state of nanotechnology regulation.  However, the even split was somewhat unexpected.  The debate seems to center around the data submissions by companies seek FDA approval on products and what is already required.  I, personally, would not have thought the division would be so even (unless purposefully manufactured).  Perhaps this is a mircochasm of the public generally, that being a 50/50 split on what the next step should be?  Or perhaps this is administrative gridlock in an election year?  Or perhaps this is simply an administrative agency continuing to act deliberately in considering the nanotechnology question?
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Expert Says FDA Should Ensure Capacity to Address Nanoapplications

Posted on November 6, 2006 by John C. Monica, Jr.

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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