Big Molecule Watch
July 29, 2022

Updates on Pending Legislation: Citizen Petitions

The Big Molecule Watch is monitoring pending legislation in Congress that relates to biosimilars and biologics.  In this post, we check in on the status of two currently pending bills related to Citizen Petitions.

The first is H.R. 2883, Stop Stalling Access to Affordable Medications, which aims to stop the anticompetitive practice of stalling generic drug or biosimilar approvals through submissions of “sham” Citizen Petitions.  The intent of the bill is to “foster competition and facilitate efficient review of petitions filed in good faith to raise legitimate public health concerns.”  H.R. 2883 classifies “sham” petitions as those that are objectively baseless and are intended to use a governmental process to interfere with the business of a competitor.  Submission of a “sham” Citizen Petition would be an unfair method of competition and would open the submitter to Federal Trade Commission (“FTC”) liability under Section 5(a)(1).

H.R. 2883 was introduced on April 28, 2021, by Rep. Hakeem Jefferies (D-NY), and has seven cosponsors (five Democrats and two Republicans).  The bill underwent full committee consideration and markup by the House Judiciary Committee on September 30, 2021, and there has not been any further action since then.

The other pending bill, proposed in the Senate, S. 562, Ensuring Timely Access to Generics Act of 2021, also addresses “sham” Citizen Petitions and provides factors that may be considered when determining whether a petition was submitted with the primary purpose of delaying an application.  Those factors include: whether the petition was timely, whether the petition was one of a series of petitions that could have been consolidated, whether the petition was filed close to a time an application could be approved, whether the petition was filed without sufficient scientific support, whether the petition is aimed at content previously in a petition, whether the petition requests changes to the applicable standards, and the petitioner’s prior record of petition.  The proposed bill also establishes procedures for referral to the FTC.

Senate Bill 562 was introduced on March 3, 2021, by Sen. Jeanne Shaheen (D-NH), and has three cosponsors (one Democrat and two Republicans).  It was read twice and referred to the Senate Health, Education, Labor and Pensions on March 3, 2021.  There has been no subsequent action relating to S. 562.


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