Senate Passes Drug Safety Bill With Industry-Backed Advertising Provisions

Industry Still Faces Hurdles in the House

After weeks of negotiations, the Senate yesterday passed the drug safety bill, S.1082, without major new restrictions on direct-to-consumer prescription drug ads. As you may be aware, the original bill contained a two-year moratorium on advertising for new drugs, preclearance of ads by the FDA, and new mandatory warning requirements for advertising. We were also successful in overcoming an effort by Senator Tom Harkin (D-IA) to impose major new disclosure requirements. These restrictions, if passed, would have severely hampered the ability of drug companies to advertise new products.

Instead, as part of an industry compromise, the bill contains new civil penalties for false and misleading ads as proposed in an amendment by Senator Pat Roberts (R-KS). We are very appreciative of the support of Senator Roberts, as well as from Senators Richard Burr (R-NC) and Tom Coburn (R-OK).

The bill passed on a 93-1 vote and now goes to the House of Representatives. The House version of the bill (H.R. 1561), sponsored by Congressmen Henry Waxman (D-CA) and Ed Markey (D-MA), contains a three-year moratorium on advertising for new drugs. It is not clear when the House will take up the bill, but we will notify you when there are further developments.

If you have any questions, you can reach Dan Jaffe in ANA's Washington office at 202-296-2359 or at