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THE LATEST: FTC Submits Comment on FDA Guidance Aimed at Deterring Abuse of Citizen Petition Process

The Federal Trade Commission (FTC) submitted comments supporting the Food and Drug Administration’s (FDA) guidance for assessing whether a pharmaceutical company petitioner is misusing the citizen petition process to delay approval of a competing drug. WHAT HAPPENED: The FDA released revised draft guidance intended to discourage pharmaceutical companies from gaming the citizen petition process. The FTC expressed approval of the considerations the FDA will use to determine whether a petition was submitted to delay or inhibit competition. The considerations the FDA will use include: The petition was submitted unreasonably long after the petitioner learned or knew about the relevant information; The petitioner submitted multiple and/or serial petitions; The petition was submitted close to the expiration date of a known patent or exclusivity; The petition’s scientific positions were unsupported by data or information; The petition was the same or substantially...

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Physicians Write Letter to FDA Regarding Biosimilar Naming Concerns

On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the implementation of the Biologics Price Competition and Innovation Act (BPCIA). Unlike traditional small-molecule prescription drugs, most biologics are complex and are typically made from human or animal materials.  The BPCIA provides an abbreviated licensure pathway for biologics that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic.  A biologic may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biologic.  Unlike “generic” versions of small-molecule prescription drugs, biosimilars are not bioequivalent to their reference biologics.  To date, the FDA has not approved any biosimilar products. The licensure pathway...

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