Two Democrat members of the US House of Representatives’ Energy and Commerce Committee have introduced new drug safety legislation which, they claim, goes further than its companion bill in the Senate.
Representatives Henry Waxman and Edward Markey say that, while the Senate bill - Democrat Edward Kennedy and Republican Mike Enzi’s Enhancing Drug Safety and Innovation Act of 2007 (S 484) - represents a “significant step forward” in addressing the “serious improvements” needed in the US drug safety system, House bill HR 1561 “goes even further in giving the [Food and Drug Administration] the full complement of tools it needs to protect our citizens from unsafe products.”
HR 1561 seeks to give the FDA greater powers to ensure the safety of prescription drugs after they have reached the market through the Risk Evaluation and Mitigation Strategy process, with a raft of proposals which include: increasing the possible moratorium on direct-to-consumer advertising to three years, up from the two years proposed by Sens Kennedy and Enzi; requiring the agency to place a symbol on the packaging of a drug to let consumers know it is new to the marketplace; and to conduct a review of all medicines once they have been on the market for seven years.
The bill would also increase the transparency of the REMS process, making any disputes brought before the Drug Safety Oversight Board a matter of public record, and requiring the agency to report to Congress on its efforts to integrate the expertise of the Office of Surveillance and Epidemiology (formerly Office of Drug Safety) into FDA approval, labelling and post-approval decisions.
Empowering the FDA to fine drugmakers
It would empower the FDA to fine drugmakers which do not comply with Federal Food, Drug and Cosmetic Act requirements and also strengthen the publicly-available clinical trials registry, which the Kennedy-Enzi bill would establish, to include more information on a greater number of trials. HR 1561 would also authorise the Secretary of Health and Human Services to impose financial penalties on companies found to be non-compliant.
Drugmakers cannot continue to be allowed “to cherry-pick and distort the clinical trial information on which physicians rely about which drugs work and the risks those drugs pose,” said Sen Waxman, who also serves as chairman of the House Committee on Oversight and Government Reform.
The Kennedy-Enzi bill was introduced in the Senate on February 1. The day before, Senators Chuck Grassley (Republican) and Christopher Dodd (Democrat) introduced their Food and Drug Administration Safety Act of 2007, which seeks to set up a new centre within the FDA for monitoring the safety of drugs and biologics once they are on the market.