A funny thing happened on my way to the Business of Biosimilars conference in Boston -- a draft document about a two-day FDA public hearing on FOBs began making the rounds.
According to the draft, the hearing will take place on November 2nd and 3rd and, potential changes notwithstanding, provides insight into the future of FDA-regulated biosimilars.
"The purpose of this public hearing," the document states, "is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute concerning the following issues, among others:
* Scientific and technical factors related to a determination of biosimilarity or interchangeability;
* The type of information that may be used to support a determination of biosimilarity or interchangeability;
* Development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products;
* Scope of the revised definition of a “biological product”;
* Priorities for guidance development;
* Scientific and technical factors related to reference product exclusivity;
* Scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and
* The establishment of a user fee program for biosimilar and interchangeable biological products."
An ambitious agenda for two-weeks or two months – let alone two days. But, you’ve got to start somewhere.
And none too soon if the frustration, confusion, angst and agita (pardon the mixed ethnography) at the Boston confab is any indication of the larger issues in play.
And from the “Use That Gavel While You’ve Got It” department, draft legislation unveiled Monday (courtesy of Representatives Henry Waxman, Frank Pallone, John Dingell, and Bart Stupak) aimed at boosting the FDA's authority to monitor the sale of prescription drugs, which increasingly occurs on a global scale.
"Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how," Dingell said in a statement.
The draft legislation would require "parity" between inspections of foreign and domestic drug manufacturing plants. Now, overseas production sites are inspected much less often than U.S.-based facilities. It also would require that manufacturers "ensure the safety of their supply chain" and would give the FDA power to mandate recalls of unsafe medicines.
Dingell stated, "Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how."
“How,” it seems, is the order of the day.
