WASHINGTON - Comments from FDA officials have convinced the Biotechnology Industry Organization that the agency is willing to establish a generic pathway for some biotechnology products.
BIO responded by drawing up a 70-page citizen petition (available at www.bio.org) asking the agency to solicit public participation on scientific, legal and policy issues before adopting any new "pathways," regardless of how small or insignificant they may seem.
Current law governing generics is known as the Hatch-Waxman Act of 1984, which does not include biologics. Several lawmakers have challenged the act, saying their plan is to reform it in order to prevent large pharmaceutical companies from abusing loopholes, particularly one that allows a company to stack patent extensions, therefore delaying generic introduction to the market. President Bush issued a proposed regulation in November limiting patent extensions to one 30-month stay.
But this newest threat comes from within the FDA.
Most biotechnology products are licensed under the Public Health Service Act as biological products. However, certain biotech products, like insulin and human growth hormone, were approved as new drugs under the Federal Food, Drug and Cosmetic Act (FDCA), which allows for abbreviated approvals for generics. While that latter act doesn't specifically address biotech products, it certainly gives the industry cause for concern.
Specifically, in its petition, BIO says, "Recent FDA statements suggest that the agency is contemplating the possibility of allowing follow-on [generic] approvals of [certain] therapeutic protein products regulated as new drugs under the FDCA, including recombinant products."
And then, at a Food and Drug Law Institute meeting here in early April, FDA Commissioner Mark McClellan said the science involved in developing biologics is too complex to include them under a generics rule. However, he did say the agency's long-term goal is to create a regulatory and scientific pathway for generic biologics. (See BioWorld Today, April 2, 2003.)
When asked to elaborate on BIO's position on generic biologics, Steve Lawton, BIO's vice president and general counsel, told BioWorld Today, "The petition does not say that there will never be a scientific pathway or approval of well-characterized biotech products. We are saying there are too many questions today to support that kind of a concept and that regulatory action today. What we have seen is that slight changes in the manufacturing practices of biotech products can cause significant changes in how a product works, and this needs to be addressed before any form of generic pathway is established."
In its petition, BIO says of the manufacturing process, "In contrast to other drug products, biologically derived products' manufacturing processes involve numerous complicated steps based upon the production and secretion of the biologically active molecule by living cells or organisms, the response of which are inherently variable."
Furthermore, it says heterogeneity and contamination can occur in any step, and biologically derived products are sensitive to many conditions such as temperature, shear forces, enzymatic activity and formulation changes.
Regarding developing a generic biologic, in prepared remarks BIO says such medicines must be based on a full complement of original nonclinical and clinical data because of the unique scientific nature of the products.
"In the public participation process, we believe that a significant portion of the discussion should be directed to the scientific aspects of the issue but should also address how trade-secret manufacturing data of pioneer developers will be protected," Lawton said.