A Look At Abbott's Citizen Petition Against The Biologics Price Competition And Innovation Act

When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the "Biologics Act") may have breathed a sigh of relief. However, the Biologics Act is not out of the woods, because Abbott recently filed a Citizen Petition with the FDA, seeking to block its implementation of the law as unconstitutional.

The Biologics Act

The Biologics Act creates a path to market entry for biological products that is similar to (but substantially different from) the path provided to small molecule drugs by the Drug Price Competition and Patent Term Restoration Act of 1984 (generally known as the "Hatch-Waxman Act"). (A copy of the law is available through the FDA's Biosimilars webpage.) Key differences in the regulatory approval provisions of the Biologics Act reflect the complex nature of biologics and the safety and efficacy concerns surrounding biological products that may not be chemically identical to the approved reference product. The Biologics Act also has a completely different mechanism for treating patent issues than those set forth in the Hatch-Waxman Act. ( This article provides a more detailed discussion of the Biologics Act.)

Like the Hatch-Waxman Act, the Biosimilars Act arose from a desire to facilitate market entry of lower-cost "generic" versions of biological drugs. For example, at the Biosimilars 2007 Conference, Representative Henry Waxman remarked that "biotech drugs are the future of medicine." In 2006, the last year for which data is available, biotech sales grew by 20% to $40.3 billion, while sales of traditional, small molecule pharmaceuticals increased by only 8%. With skyrocketing pharmaceutical costs and increased consumer demand, lower-cost alternatives are understandably a priority. However, the demand for "generic" versions of biologics must not take precedence over the need to ensure the safety and efficacy of approved pharmaceutical products and must be balanced against the need for sufficient market exclusivity for innovator products to incentivize continued research and development.

The Biologics Act attempts to balance these competing interests by providing timeframes of exclusivity to innovator (reference) biologic drug products. For example, an application for FDA approval of a biosimilar product can be filed four years after approval of the reference product, but the...