May 6, 2014  -  Senator Lamar Alexander (R-TN), the ranking Republican on the Senate HELP Committee (Health, Education, Labor, and Pensions) has written to FDA Commissioner Hamburg requesting clarification on FDA's use of Draft Guidances rather than formal Notice-and-Comment Rulemaking.

As practitioners of FDA law know, some outstanding Draft Guidances date back to the last Century and, in the absence of Final Rules, often provide FDA's stakeholders with inadequate information on which to make business and legal decisions.

Senator Alexander's letter requests: (1) a list of each currently open Draft Guidance; (2) the issue date of each; and (3) the date by which each Draft Guidance will be withdrawn or isssued as a Proposed Rule.

We post the letter below: