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Tag Archives: drug

S. 3187, “Food and Drug Administration Safety and Innovation Act” passes in Senate

Prior to adjourning for the Memorial Say recess, the Senate, on 05/24/2012, by a vote of 96-1, passed  S. 3187, the "Food and Drug Administration Safety and Innovation Act", " To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes", after previously adopting an amendment in the nature of a substitute-  an amendment in the nature of a substitute strips all of the language of a bill following the enacting clause and replaces it with new language – offered by Senator Tom Harkin (D-Iowa). Included as part of the language of the amendment was Title XI – Other Provisions, Subtitle C- Misc. Provisions, Section 1133, "Nanotechnology Regulatory Science Program":

SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    (a) In General- Chapter X (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

`SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    `(a) In General- Not later than 180 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary, in consultation as appropriate with the Secretary of Agriculture, shall establish within the Food and Drug Administration a Nanotechnology Regulatory Science Program (referred to in this section as the `program’) to enhance scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under this Act or other statutes administered by the Food and Drug Administration, to address

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 …

Take two silver nanoparticles and call me in the morning

For decades after it was discovered, penicillin was used to combat bacteria and, eventually, almost every other disease, whether it was the appropriate treatment or not. Over time and over use of penicillin and its successor drugs, resistant strains of bacteria began to appear, to the point where, now, many strains of bacteria are almost completely drug resistant.

According to a recent article posted to the Australian Broadcasting Corporation (ABC) site, nanosilver might become the 21st century’s penicillin, being widely used in the medical field, but also in consumer products, such as combs, hair dryers,  men’s socks, and underwear.

Some of this overuse of nanosilver is probably due to companies simply following trends and wanting to appear cutting edge or it may be due to marketing efforts that fall into the "All New!" category. Other companies may be adding nanosilver as part of a genuine effort to improve their products and make them healthier, although how much healthier underwear is with nanosilver as opposed to underwear without is a debate probably best left to others.

While a total ban on the sale of products containing nanosilver, which groups such as Friends of the Earth propose is unlikely, (and frankly seems more like simplistic fear mongering than anything else), regulations on the amount of nanosilver in consumer products, based on the results of reputable studies and tests on the effects on humans and bacteria of prolonged exposure to nanosilver particles are needed.

Personally, I’d start by regulating the amount of silver …

Nanotechnology Conference: Food & Drug Law Institute

The Food & Drug Law Institute is holding its 2nd Annual Conference on Nanotechnology Law, Regulation and Policy on February 18-19, 2009 at the L’Enfant Plaza Hotel in Washington, DC.  Register here.

Topics include:

  • What progress is FDA making in implementing its Nanotechnology Task Force Report?
  • What can FDA learn from EPA and other oversight agencies the National Nanotechnology Initiative (NNI)?
  • Will the Democratic Congress invest in and/or regulate nanotechnology more than under the Bush Administration?
  • Are workers exposed to asbestos-like dangers from dealing with nano products?
  • How does a responsible company devise a risk management plan for nanotech
  • development — one that takes into account OSHA and NIOSH policy?
  • What is reasonable and required federal funding for U.S nanotechnology R&D, including monies for safety and social policy research?
  • Are China and Japan ahead of the U.S. in nanotech development?
  • For nanotech products and processes, should particle size make a regulatory difference?

Nanotechnology: A New Weapon in the Battle Against Counterfeit Goods

By Laurie N. Jacques:

Counterfeiting is widespread because it is lucrative and often difficult to detect. Nanowerk highlights the use of nanotechnology in the battle against counterfeit goods. Nanoencryption provides a new option for distinguishing between genuine and counterfeit goods, particularly pharmaceuticals.

Drug counterfeiting is particularly problematic because it compromises patient safety in addition to causing monetary losses and erosion of brand value. The Center for Medicine in the Public Interest estimates that counterfeit drug sales are growing at an annual rate of about 13% – nearly the twice the growth rate of genuine pharmaceutical products – and could reach $75 billion by 2010. …

Nanoparticles Used as a Topical Drug Delivery Device

Pharmos Corporation recently announced the completion of its first round of testing of a topical cream used as a drug delivery device for an anti-inflammatory drug. Pharmos stated the test data indicated there were no “severe or serious adverse events” and that the “formulation was safe and well tolerated” in human test subjects. Pharmos applauded the “skin penetrative properties” of the nano-forumlation, and pointed to successful animal studies indicating “excellent targeted delivery” through this method.

PR Newswire US, November 14, 2006, “Pharmos Completes Phase 1 Study of Topical Diclofenac NanoEmulsion Cream; Data Indicate Positive results Achieved on Safety, Tolerability and Pharmacokinetics.” …

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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