Technology Law Source

Tag Archives: Senator Mark Pryor

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":


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


    `(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

The Nanotechnology Safety Act of 2010

On Thursday 01/21/2010, Senator Mark Pryor (D-Ark) introduced S. 2942, "The Nanotechnology Safety Act of 2010", the first nanotechnology related bill of the 2nd session of the 111th Congress. The bill is co-sponsored by Senator Benjamin Cardin (D-MD). The text of S. 2942 has not yet been made available by the Government Printing Office; the link above is to Senator Pryor’s introductory remarks in the Congressional Record. The text of S. 2942 as introduced follows the Senator’s remarks.

In his introductory remarks Senator Pryor stated that the bill would "authorize a program of scientific investigation by the Food and Drug Administration on nanotechnology based medical and health products . . . . [to] enable the FDA to properly study how nanomaterials are absorbed by the human body, how nanomaterials designed to carry cancer fighting drugs target and kill tumors, and how nanoscale texturing of bone implants can make a stronger joint and reduce the threat of infection."

Senator Pryor also noted in his remarks that

The FDA needs the tools and resources to assure the public that nanotechnology-based medical and health products are safe and effective. The development of a regulatory framework for the use of nanomaterials in drugs, medical devices, and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust scientific framework there is no way to know what data to collect. More than a dozen material characteristics have been suggested even for relatively simple nanomaterials. Without better …