House Passes FDA Reauthorization Act

On Wednesday, the US House of Representatives passed the FDA Reauthorization Act of 2017 (FDARA), which, among other provisions, reauthorizes user fees for biosimilar product applications. The bill, sponsored by Representative Greg Walden (R-Oregon), was passed by a voice vote.

Representative Walden hailed the bill’s passage, which he says will “…streamline the process for reviewing and approving new treatments and cures for patients, ultimately delivering new and innovative therapies, drugs, and devices to patients more quickly.”

The bill will now proceed to the Senate, where the legislation has broad bipartisan support and is expected to pass. The Senate will reportedly vote on the House version of the bill without amending its language. A vote on the House’s legislation would obviate the need for lawmakers to reconcile separate House and Senate bills.

Despite the Senate’s streamlined approach to moving forward with FDA reauthorization, at least 1 Senator is expected to vote no on the bill: Senator Ron Johnson (R-Wisconsin) said that he would seek to prevent the bill’s passage if it is not amended to include a “right to try” provision. Senator Johnson is a vocal advocate for policies that would allow patients who have terminal illnesses to try experimental treatments that have not yet been approved by the FDA.

The biotechnology industry is eager to see the Senate pass the legislation to reauthorize the FDA and its user fee programs so that the FDA may proceed with its activities. James C. Greenwood, president and CEO of BIO, a trade association representing biotechnology organizations, said “We applaud the work of the House for making sure that this important legislation remained a priority…We urge the Senate to swiftly consider and pass the Act to ensure the continuity of the FDA’s many critical functions, and so that patients may begin to benefit from the important advances in drug development that the Act will usher in.”

The Congressional Budget Office, in its report on the House bill, estimated that the cost of the Act’s mandates on private entities for user fees would exceed $156 million for each of the first 5 years of the Act’s term.

The White House remains unconvinced that the user fees laid out in the legislation go far enough; today, the White House called for the FDA to fund 100% of premarket review costs through user fees. "In an era of renewed fiscal restraint, industries that benefit directly from FDA's work should pay for it," the official statement claims. Nevertheless, the Administration said that it supports the Act and looks forward to the expanded patient access that reauthoirzed user fee programs will provide.