While a Supreme Court ruling on the constitutionality of the healthcare reform law is not expected until June, sponsors and regulators continue to lay the groundwork for biosimilars in the U.S. An unintended consequence of embedding the Biologics Price Competition and Innovation Act within PPACA without a severability clause leaves the biosimilars law vulnerable to the fate of constitutional challenges to more controversial parts of the Affordable Care Act.
The Supreme Court recently concluded three days of oral argument challenging the constitutionality of several provisions of PPACA. There was general agreement amongst the petitioners, defendants and the Justices that the biosimilars provisions are “peripheral” to the challenges under review by the Court. Nevertheless, it remains possible that if the Court decides any one provision (such as the so-called “individual mandate”) is unconstitutional, rather than parsing out the constitutional bits, even those recognized to be peripheral to the provisions at issue, the Court could strike down the entire Act to let Congress sort it out. So even though “the biosimilar thing,” as described by Justice Breyer, would seem to stand on its own without the other parts of the Act, the BPCIA could be swept into a sweeping decision that would invalidate the biosimilars pathway along with the rest of the Act.
The BPCIA was the result of significant bipartisan effort and support in both the House and Senate. FDA reports (PDF) at least 35 requests for biosimilar pre-IND meetings as of February 15 and is holding a public meeting on the three issued draft biosimilar guidances in May. If the Supreme Court throws out the BPCIA with the bath water, it is reasonable to expect that the law would be re-enacted as a stand-alone. However, as we head into the presidential election season, the ability or will of Congress to enact any laws may come to a halt. There is little profit here in speculation, but in terms of setting expectations, it is possible that the BPCIA would come off the books temporarily, leaving many interesting questions about the legal significance of the gap period if the law were re-enacted in, say, early 2013.