Senate HELP Committee to Markup Kennedy-Enzi Drug Safety Bill Next Wednesday

The Senate HELP Committee plans to mark up S. 484, the Enhancing Drug Safety and Innovation Act, on Wednesday, April 18.  The bill contains three provisions of concern to the advertising industry, which the bill describes as part of a "risk evaluation and mitigation strategy."  First, under the risk evaluation and mitigation strategy, the FDA can mandate preclearance of all prescription drug advertisements.  Ads must be submitted no later than 45 days before dissemination.  The FDA could then propose changes or modifications to the ads to the drug company.  Second, as part of the preclearance process, the FDA can mandate specific further warnings and disclosures for the ads.  Finally, if the FDA believes these measures would be ineffective, it can impose a moratorium on advertising for the drug for up to two years. 

It is important that you contact members of the Senate HELP Committee to oppose these provisions.  We have prepared some materials you may wish to use to help develop your comments. 

We believe that these provisions would infringe on the commercial speech rights of prescription drug advertisers.  Additionally, there is no evidence that limits on speech such as these will promote drug safety.  Instead, these restrictions may slow down or block advertising for hundreds of new medications that will come to market in the next few years.  The substantial public health benefits provided to consumers by prescription drug advertising may be lost if these restrictions are approved. 

We are preparing a letter to the Senate HELP Committee.  If we learn of any further developments, we will contact you.

Also, if you have any questions, you can contact Dan Jaffe ( or Keith Scarborough ( in ANA's Washington office at 202-296-1883.

UPDATE:  Senator Kennedy has released S. 1082, his amendment in the nature of a substitute to be introduced at the committee hearing.