The Washington Legal Foundation last month urged the FDA to defer all work on any applications for approval of biosimilar products, where the application is based on a reference product for which the biologics license application (BLA) was filed before March 23, 2010.
The Washington Legal Foundation (WLF) is a non-profit legal organization based in Washington, D.C. Founded in 1977, the Foundation’s stated goal is “to defend and promote the principles of freedom and justice.” The organization promotes pro-business and free-market positions and is widely perceived as conservative. WLF addresses a range of legal matters, including commercial free speech, corporate criminal liability, environmental regulation, food and drug law, health care, and intellectual property.
While urging FDA about biosimilars, WLF argued that approval of such applications would require use of trade secret information that was submitted to FDA based on assurances that the trade secrets would be maintained. WLF asserted that use of such information to approve biosimilars would expose the federal government to massive liability under the Fifth Amendment’s Takings Clause.
WLF filed its comments with FDA in support of a Citizen Petition filed in 2012 by Abbott Laboratories. Abbott is licensed to market several biological products, including Humira, a TNF inhibitor widely prescribed to treat rheumatoid arthritis and other conditions. Abbott’s petition argued that FDA use of its trade secrets (or the trade secrets of any other BLA sponsor that submitted its BLA before March 2010) to approve a biosimilar would destroy the value of the trade secrets and would trigger a federal obligation to provide “just compensation” under the Fifth Amendment based on the value of the lost trade secrets. FDA has not taken any action on Abbott’s petition.
“WLF is concerned that approving biosimilars without first giving serious consideration to Fifth Amendment compensation claims that would arise therefrom would seriously erode both property rights and public confidence in the reliability of government promises,” said WLF Chief Counsel Richard Samp after filing WLF’s comments. “If FDA determines that it is free to ignore its past promises of confidentiality to BLA applicants, businesses subject to government regulation will be less willing in the future to spend the massive sums necessary to develop innovative and life-saving products,” Samp said.
The federal government has regulated the marketing of biological products since 1902. Before issuing a license to market such products, FDA requires the BLA applicant to demonstrate that its products meet standards designed to ensure “safety, purity, and potency.” Several studies have concluded that research and development costs for a new biological product range from $1.24 billion to $1.33 billion.
Source: WLF, Wikipedia