Senator Gregg's Drug Safety Surveillance Provision Included in FDA Reform

Press Release

Senator Gregg's Drug Safety Surveillance Provision Included in FDA Reform Bill

Gregg joins majority as reauthorization measure passes Senate by 93-1 vote

U.S. Senator Judd Gregg (R-NH), a member of the Senate Health, Labor, Education, and Pensions Committee, today applauded passage of the Food and Drug Administration Reauthorization Act approved by the Senate, with Senator Gregg's support, earlier today. Senator Gregg's language, based on S. 1024, the Safer DATA Act he introduced earlier this year, was included in the final bill. It puts drug safety data surveillance at the center of the FDA's efforts to monitor and improve the safety of our nation's drug supply. The language pools existing data and technology to establish an active post market surveillance system to identify risks that may need further action or study. The HELP Committee passed the FDA reform bill on April 18.

"This bill puts science at the center of drug safety," stated Senator Gregg. "It is critical that the FDA have a tool that allows them to collect and analyze the safety of prescription drugs after they are brought to market."

In addition to the Safer DATA language, the measure includes language Senator Gregg offered during the HELP Committee mark-up to clarify that the FDA may only require a Risk Evaluation and Mitigation Strategy (REMS) when informed by scientific information, such as the data collected and analyzed by the surveillance system. The final bill also includes language Senator Gregg authored to provide an emergency exemption for bioterror countermeasures from the provisions in the bill that limit a physician's ability to prescribe medicine to their patients in the event of a public health emergency.

"In a time of a bioterrorism crisis, medical professionals and first responders must have the resources they need to treat patients effectively and to prevent the spread of any bioterror agent. Previous versions of this bill included language that prevented physicians from exercising their training and discretion in treating their patients during a bioterror event. I am pleased my language has been included which removes these roadblocks and allows medical professionals to do what they do best - treat their patients.

"Significant improvements have been made to this measure since it was passed by the HELP Committee last month. This bill makes already effective programs stronger and will ultimately benefit the thousands of Americans who rely on these programs to make their lives better. I look forward to working with my colleagues in the House and Senate to make further improvements as this bill progresses

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