House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) and committee Chair John Dingell (D-Mich.) "face a likely battle in conference negotiations to work out differences with" the Senate on a bill to reauthorize the Prescription Drug User Fee Act that includes a number of prescription drug safety provisions, CQ HealthBeat reports. At a subcommittee hearing on a draft of the House version of the bill on Tuesday, Pallone said that "drug safety provisions will be the most contentious" issue in negotiations with the Senate, which approved a version of the legislation (S 1082) on May 9.
The House version of the bill includes a provision that would require a "Risk Evaluation and Mitigation Strategy" for all new medications approved by FDA, and one of the "most contentious sections of the REMS provision will likely be its restrictions on direct-to-consumer advertising of new drugs," CQ HealthBeat reports. Under the provision, the HHS secretary could require FDA to review and approve DTC ads for new medications before they air, a requirement that subcommittee Republicans maintain would violate the First Amendment.
Michael Burgess (R-Texas) said, "I'd be very surprised if it wasn't challenged" on constitutional grounds. However, Pallone said that the requirement would not violate the First Amendment because the provision does not include a total ban on all DTC ads for new medications. A Democratic aide to the committee said that the requirement likely would survive a constitutional challenge "because it's on a case-by-case basis, not a flat-out moratorium on advertising to all new drugs."
The pharmaceutical industry also opposes the requirement. Caroline Loew, vice president of the Pharmaceutical Research and Manufacturers of America, said, "Restrictions on advertisements would deny patients access to important information, which repeated studies have shown to be valuable in educating patients and fostering patient-physician dialogue" (Armstrong, CQ HealthBeat, 6/12). Litigation Concerns
Subcommittee Republicans and Bush administration officials also questioned language in the bill that indicates strict compliance with FDA rules would not protect pharmaceutical and medical device companies from product liability lawsuits filed in state courts. Randall Lutter, associate commissioner for policy and planning at FDA, said, "We think that pre-emption language would essentially have the effect of formalizing in federal statute a collection of state actions that may be contradictory to or inconsistent with FDA actions on the safety and effectiveness of FDA-regulated products." Burgess said, "I believe it will open up the state courts for a situation that might be deemed 'litigation for all'" (Edney, CongressDaily, 6/12).
Ken Johnson, a senior vice president at PhRMA, said that the language "would allow state juries and judges essentially to overrule FDA's expert judgment about prescription drug labels and warnings, which could ultimately confuse physicians and patients who rely on clear, concise and consistent labeling directions" (CQ HealthBeat, 6/12).
Subcommittee Republicans also questioned the schedule for the mark up of the legislation. The subcommittee plans to mark up the bill on Thursday, and the full committee plans to mark up the legislation next week. Subcommittee ranking member Nathan Deal (R-Ga.) said, "Recent action in the Senate on a similar package of proposals demonstrated that the two sides can work together to reach a consensus and preserve patients' access to life-saving medications. Unfortunately, as I see the schedule, there's little time for the two sides to work together to move a largely more bipartisan package" (CongressDaily, 6/12).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Publication Date: 2007-06-15 21:00
|
