At a June 23, 2004 hearing, Chairman Orin Hatch (R-UT) and several Democratic members of the Senate Judiciary Committee questioned FDA's slow approach to resolving the complex issue of approval of Follow-On Biologics. The surprise hearing - at which representatives of the FDA and both the pioneer and generic biologics industry were hurriedly called to testify - was convened to discuss the possible creation of an abbreviated approval program similar to the ANDA or 505(b)(2) application process currently in effect for chemically synthesized pharmaceuticals and whether the Agency even has the legal authority to create such a program.

FDA Acting Commissioner Lester Crawford and FDA General Counsel Daniel Troy confirmed what BIO members learned in San Francisco - that FDA will not be issuing its long-promised Guidance on Follow-On Biologics anytime soon. [The Agency had previously said that a Guidance would be issued in the Spring or Summer of 2004.] In fact, Crawford told the Committee that the FDA had decided first to hold a "public workshop" in collaboration with the Drug Information Association to address the scientific issues associated with any new approval process. Crawford told the Committee that he anticipated that the workshop would be held "shortly after Labor Day."

Chairman Hatch and Senators Patrick Leahy (D-VT), Richard Durbin (D-IL), and Charles Schumer (D-NY) all questioned why this process was taking so long and why the Guidance had been so delayed. Chairman Hatch promised to continue to press FDA, and he and Senator Schumer said they would be submitting detailed written questions to the Agency on this issue.

Witnesses from both the pioneer and generic industries testified that legislation for follow-on biologics was probably inevitable and they also agreed that FDA should address the scientific issues before any legal concerns. The witnesses differed, however, on the scope and breadth of the eventual legislation. They also disagreed on whether current law provides FDA with the authority to approve Follow-On Biologics and on the role that these scientific issues - including the complex molecular structure of many biological products and the difficulty in characterizing them - should play in shaping an abbreviated approval pathway for Follow-On Biologics.

Senator Leahy suggested that FDA consider adopting a sliding-scale regulatory approach, in which the level of scientific and regulatory scrutiny would increase with the biologic's level of complexity. The witnesses for the generic pharmaceutical industry generally agreed with this approach, urging that FDA not delay approvals until it had resolved all scientific issues. As might be expected, the pioneer industry witnesses disagreed, maintaining that because there were significant, unresolved scientific issues with Follow-On Biologics, these issues would need to be resolved first before any approval mechanism could be developed.

An abbreviated pathway for the approval of follow-on biologics will continue to evolve and, with Congressional involvement, FDA will be forced to place the issue near the top of its regulatory agenda. The issue merits continual monitoring.

Afterward

The battle over Follow-On Biologics is likely to continue for quite some time. Indeed, today, Steve Irizarry, Counsel to the Senate Committee on Health, Education, Labor and Pensions, informed participants at a Follow-On Biologics conference in New York that Senator Judd Gregg (R-NH) and other members of that Committee are "very concerned" about the legal and regulatory issues that Congress will need to address before any sort of abbreviated approval pathway may be determined. Mr. Irizarry went so far as to say that Senator Gregg and other members believe that Congress should address these legal issues before FDA releases its draft guidance.