Since May 4th when the full Senate passed the drug safety bill, the action has moved to the House. While the press has focused on the Avandia dust-up orchestrated by Congressman Henry Waxman (D-CA) in the House Government Reform Committee, the action on the drug safety bill will begin next week in the House Energy and Commerce Committee headed by Congressman John Dingell, (D-MI). 

After an extensive lobbying effort by the Advertising Coalition supported by articulate messages to Senate offices by many Coalition members, the Senate adopted limited and constitutionally-friendly marketing provisions. These provisions include pre-submission of DTC ads to the FDA (but not pre-clearance) and allow FDA to impose fines on drug advertisers who repeatedly violate its marketing rules.

Unfortunately, the House is not starting with the final Senate version, but with provisions proposed by Congressmen Waxman and Markey that are even more onerous than the initial Senate proposals. The Advertising Coalition, composed of media and advertising industry lobbyists including the American Association of Advertising Agencies, is very actively lobbying members of the House Energy and Commerce Committee  to adopt the Senate version instead.

The Advertising Coalition  has learned that the Health Subcommittee,  chaired by Rep. Frank Pallone (D-NJ), will move quickly next week with a hearing on Tuesday and a markup on Wednesday. Then, probably during  the final two weeks of June, the full House Commerce Committee, led by Congressman  Dingell, is expected to vote on the bill and forward it for a full House vote before the end of the summer.

The current draft of the drug safety legislation that Congressman  Pallone (D-NJ) is expected to offer next week contains some of the worst provisions of the Waxman-Markey bill, including mandates that the FDA impose onerous marketing limits on every new drug and any existing drug with new safety issues. The Pallone drafts are said to require a DTC ban on newly approved drugs, mandatory pre-clearance of  ads by the FDA, and new detailed warnings on even unknown risks. If adopted, these restrictions will severely curtail most prescription drug advertising, and limit virtually all other forms of drug promotion and marketing. 

The Advertising Coalition is urging industry professionals to contact Members of the House Energy and Commerce Committee and tell members their concerns. It is strongly urging professionals to phone, fax, and/or email Members with whom you have a relationship or where your company has a base of operations. Linked here is the contact information for members of the Energy and Commerce Committee and their principal health staffers. Also linked are "talking points" that the Advertising Coalition is suggesting be used in those messages. The Advertising Coalition suggests that the messages be directed to the health legislative assistant as soon as possible.

House Contacts
Talking Points