Reps. Waxman and Allen and Sen. Kennedy Will Introduce Bill to Modernize the OTC Drug System

Yesterday, Representatives Henry Waxman (D-CA) and Tom Allen (D-ME) and Senator Ted Kennedy (D-MA) announced plans to introduce the Non-Prescription Drug Modernization Act of 2007 (“NDMA”).  The bill comes in the wake of recent concern over the use of Over-the-Counter (“OTC”) cough/cold drugs in children under 6 years old and FDA’s ability to quickly take action to address those concerns by amending OTC drug monographs. 

In October 2007, FDA’s Nonprescription Drugs and Pediatric Advisory Committees recommended, during a joint committee meeting, a ban on the use of OTC cough/cold drugs in children under 6 years old.  The joint committee was scheduled and occurred after a citizen petition submitted to the Agency in March 2007 raised concerns about the safety and efficacy of OTC cough/cold products in this pediatric population.  Subsequently, FDA announced the Agency’s plans to hold a public workshop in December 2007 with the National Institutes of Health and the Consumer Healthcare Product Association (“CHPA”) to “gain an understanding of current use of OTC drug products by adolescents.”  In addition, Rep. Waxman, following the advisory committees’ mid-October recommendation, sent a letter to CHPA urging the organization to “take prompt action to ensure that the advisory committee’s recommendations are promptly carried out by your member companies.”  On November 1, 2007, Sen. Chris Dodd (D-CT) also sent a letter to FDA Commissioner Andrew von Eschenbach asking the Agency to “take swift and comprehensive action” on the advisory committees’ recommendation by immediately removing OTC cold/cold drugs indicated for children under 6 years old, or at least mandate that new product labels state “do not use” for children under that age.

The NDMA, a summary of which is available here, would amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) by adding section 568 (“Amending or Repealing Monographs”) to provide FDA with explicit expedited rulemaking authority to amend or repeal OTC drug monographs under two circumstances:

(1) When FDA finds (on its own initiative) that an OTC drug monograph must be amended or repealed because a drug under the monograph may pose a significant risk; or

(2) When FDA finds, after an advisory committee meeting, that a drug under the OTC monograph lacks evidence of effectiveness.

No specific appeal procedure is provided in the bill.

The NDMA would expand FDA’s authority to regulate OTC drug advertising.  Currently, the Federal Trade Commission regulates OTC drug advertisements, while FDA regulates prescription drug advertisements.  The bill would also amend the FDC Act to provide civil monetary penalties for violative Direct-to-Consumer (“DTC”) OTC drug advertisements.  The recently-enacted FDA Amendments Act added civil monetary penalties for violative DTC prescription drug advertisements.  Finally, the NDMA would require FDA to identify (by establishing a public docket) and report to Congress (not later than 2 years after the NDMA is enacted) on any OTC drug monographs requiring further review to determine whether they should be amended or repealed.