Stakeholder Groups Praise Enactment of FDARA

Despite earlier White House statements indicating that the Trump administration would ask the FDA to generate 100% of its program funding through user fee programs, on August 18, the President signed the FDA Reauthorization Act of 2017 (FDARA) into law.

The FDARA reauthorizes user fees for biosimilar product applications, among other provisions, allowing the FDA to continue to fund its programs. The bill, which dramatically increases the base user fees that the agency can collect from biosimilar applicants in 2018, enjoyed broad bipartisan support in both the House of Representatives and the Senate. However, its time-sensitive passage had been repeatedly delayed as Congress turned its attentions to the broader issue of healthcare reform.

Stakeholder groups hailed the enactment of the law—the American College of Rheumatology (ACR)’s president, Sharad Lakhanpal, MBBS, MD, said yesterday that the organization “applauds the enactment of the [FDARA], which was signed into law on Aug. 18…the funds generated from the user fee program are critical to the FDA’s efforts to bring new biosimilar therapies to market as quickly and safely as possible, so we are encouraged to see Congress working in a bipartisan fashion to renew this important program.”

Lakhanpal also praised FDA commissioner, Scott Gottlieb, MD, for “spearheading a new hiring initiative—in line with the principles outlined in the 21st Century Cures Act—that allows the FDA to onboard experts in the regulation and approval of biosimilars. These innovative hiring practices will fulfill the agency’s goal of optimizing drug approvals to increase competition, lower costs, and improve patient access to safe and proven biosimilar therapies.”

The biotechnology industry also hailed the FDARA’s enactment. James Greenwood, CEO of the trade organization Biotechnology Innovation Organization (BIO), said, “BIO is proud to have played a part in these efforts and prouder still of the important advances for patients and medical innovation that this law will help achieve. Whether it be bringing patients’ perspectives more closely to bear in regulatory decision-making, speeding new medicines to market by making the clinical trial process more efficient, or increasing competition from generics and biosimilars, the provisions of this law will make our healthcare system more responsive to the needs of patients.”

The not-for-profit Project on Government Oversight, a government watchdog group, was among the lone voices of dissent on the FDA’s reauthorization. The group said that the “FDA negotiated a deal with the very industry it oversees,” and indicated that “Congress should rethink a system that leaves the FDA so beholden to industry not just for funding, but for the terms of that funding.

Congress itself disagrees; the House Energy and Commerce Committee’s statement on the FDARA says that the newly enacted law will help lower the cost of important drugs, and will help deliver therapies to patients more quickly and at a lower cost.