Republican Takeover of Senate Imperils Drug Safety

With control of the U.S. Senate now in the hands of Republican lawmakers, Congress is almost certain to pass legislation that would undermine the Food and Drug Administration’s (FDA) existing and proposed regulatory requirements for ensuring that drugs are safe and effective. Over the past four years, many such proposals have arisen in the Republican-dominated House of Representatives but, fortunately, were blocked by the Democratic-controlled Senate.

The House Energy & Commerce Committee (E&C), which has authority to craft legislation on drug safety and to oversee the activities of the FDA, has spearheaded recent efforts to weaken the FDA’s oversight of drugs and other medical products. For example, in 2014, E&C launched an initiative dubbed “21st Century Cures.”[1] Supporters of the initiative have characterized it as an effort to save patients’ lives by accelerating the pace of medical innovation and eliminating regulatory barriers to the approval of new drugs and medical devices.[2] However, measures being contemplated under the initiative — such as reducing the number and size of clinical trials for testing experimental drugs and adding more expedited FDA approval pathways — would result in faster approval of new drugs without sufficient evidence that the products are safe and effective. Profit-driven corporations undoubtedly would benefit from such efforts, but patient safety surely would suffer.

Likewise, Republican E&C members have been vocal opponents of a rule change proposed by the FDA in November 2013 in response to a Public Citizen petition. The rule change would allow generic drug companies to update the safety information on their product labels promptly. Once finalized, the change would close a safety gap that threatens the health and welfare of tens of millions of patients. However, prompted by the generic drug industry and its highly paid lobbyists, E&C members and their Senate allies may pass legislation that would prevent the FDA from finalizing this critically important rule change.

The Democratic-controlled Senate had served as a firewall against House legislation that threatened to undo important health and safety regulations. With the new Republican majority in the Senate, the House now has a willing and able partner in its mission to dismantle or block FDA regulations. Public Citizen will continue to fight to prevent these efforts from succeeding, but the struggle is going to be a whole lot harder for at least the next two years.

References

[1] U.S. House of Representatives Energy & Commerce Committee. A path to 21st century cures. April 30, 2014. https://energycommerce.house.gov/press-release/path-21st-century-cures. Accessed November 14, 2014.

[2] Ibid.