by Brian Malkin
On February 16-18, approximately 500 industry executives and stakeholders attended GPhA’s Annual Meeting in Orlando, Florida. During the public sessions to which this blog refers, representative generic industry chief executive officers (“CEOs”) were somewhat optimistic with the potential for $150 billion of branded products coming off patents (coined a “patent cliff”). Yet the overall message was more negative, focusing on slower FDA approvals, less new innovator targets for generics with greater possibilities for preemption issues regarding failures to add warnings to generic drug labelings, and an uncertain biosimilars market to replace the small molecule opportunities that will be drying up.
Deborah Autor, J.D., FDA’s Director of Compliance, Center for Drug Evaluation and Research, announced that the Office of Generic Drug’s (“OGD’s”) more than 2000 application backlog was likely to continue and possibly worsen, in part due to FDA’s inability to conduct the necessary pre-approval inspections for new drug applications–both innovator and generic. For example, Autor said that FDA anticipated that in fiscal year 2011, 192 foreign facility inspections will be required, but FDA will only be able to conduct 62. While generic application user fees could theoretically reduce approval times for new applications if FDA adopted a “surveillance model,” Autor noted that inspections were a key reason why previous negotiations for user fees failed and could fail again. Autor added that this is compounded by the fact that there are roughly eight times the number of generic to innovator applications, and generic applications tend to have more multiple supplier or facility issues with less available data during inspections. Autor hoped FDA’s message that corporate executives are accountable for FDA violations may improve the quality of generic record-keeping, including generic manufacturers obtaining better data from their suppliers.
On the generic industry side, there are greater opportunities for corporate accountability and a mixed bag for continued growth. Current legal trends suggest that leading generic applicants will likely be responsible for failures to add warnings to their products (the preemption issue). While generic growth was higher than total prescription growth (2.3 % versus 1.0%) based on market data, growth in traditional sectors such as cancer treatments were slow and other indicators showed that despite the patent cliff, the branded industry has been slow to innovate, leaving less future generic targets.