AAM Makes a Plea to Save the BPCIA

Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

Among the briefs filed in defense of the Affordable Care Act and, with it, the Biologics Price Competition and Innovation Act (BPCIA), is one from the Association for Accessible Medicines, which argues the BPCIA is vital to biosimilars market development.

Even if the Affordable Care Act (ACA) is ruled unconstitutional, the Biologics Price Competition and Innovation Act (BPCIA), which is part of that legislation and allows for biosimilar licensing, should be preserved, according to a brief argument filed by the Association for Accessible Medicines (AAM).

The Supreme Court’s deadline was this month for receiving briefs in the case of the constitutionality of the ACA. In December, the Fifth Circuit Court of Appeals agreed with a lower court that the individual mandate requiring individuals to purchase insurance under the ACA was unconstitutional, a move that put the survivability of the ACA and the BPCIA in doubt.

“FDA-approved biosimilars offer patients and taxpayers enormous cost savings on life-saving treatments,” said the AAM’s interim CEO and general counsel, Jeff Francer, in a statement. “If a constitutional challenge to some provisions of the Affordable Care Act (ACA) resulted in the invalidation of the entire ACA, including the BPCIA, a decade of progress by AAM and its members would be lost—and at a crucial moment.”

A Vital Piece of Legislation

The AAM argues that biosimilars have the potential to save $54 billion or more for patients and health care systems over the next 7 years. The BPCIA is a tool for streamlining biosimilar approvals, and therefore it is a vital piece of legislation, according to the legal brief.

“The BPCIA is exactly the type of legislation that should not be declared invalid based on a constitutional challenge to another part of the same public law….The BPCIA stands on its own and serves an important public purpose that is entirely disconnected from the insurance-related provisions of the ACA that are challenged here," the brief stated.

At issue is whether the individual mandate can be “severed” from other provisions of the act. If not, the entire ACA could be thrown out and Congress would have to enact replacement legislation to repair the damage. The ACA comprises 10 titles, and the mandate is part of Title I. Judge Reed O’Connor of the US District Court for the Northern District of Texas originally held that the mandate was so interwoven with the rest of the ACA that it could not be severed. After reviewing the case, the Fifth Circuit agreed that the mandate was unconstitutional but left it up to the Supreme Court to decide the issue of severability.

Part of what happens to the BPCIA depends on how the Supreme Court interprets Congress’ original intent, Stacie Ropka, PhD, JD, said in a recent interview with The Center for Biosimilars®.

“Did Congress intend for the entire act to rise and fall together? Looking at the BPCIA, it was originally debated as, and is intended to be, a standalone bill with provisions that are not interwoven with any other provisions of the ACA. It was sort of shoehorned into the ACA at the last minute. Thus, there’s a credible argument that Congress intended the BPCIA to remain intact even if other provisions of the ACA are found unconstitutional,” said Ropka, who practices law with Axinn, Veltrop & Harkrider LLP of Hartford, Connecticut.

The AAM contends that the BPCIA “passes every test for severability.”

Fallout from a ruling adverse to the BPCIA would remove the FDA's authority to review and approve abbreviated biologic drug applications, Ropka said. It also would abruptly halt reviews in progress for biosimilar agents. Developers instead would have to seek approval under the traditional regulatory pathway, which is not designed for biosimilars specifically and would be more cumbersome.

A key element of the BPCIA is that it allows for a biosimilar patent dispute resolution process designed to resolve intellectual property issues prior to a product’s arrival on market. Without it, developers would be faced with having to launch products at risk of litigation, and this might dissuade them from bringing biosimilars to market, which in turn could reduce the level of competition in the drug marketplace and, ultimately, the consumer benefit from lower prices.

“It’s really hard to see what kind of benefit these biosimilar developers would gain if they decided to go on a more traditional approval pathway,” Ropka said.