Last week Clarkston attended the Generic Pharmaceutical Association Annual Meeting. On behalf of all who attended I want to thank the GPhA Staff, Board of Directors, and conference presenters for another fantastic event.
The agenda was packed with today’s most important topics for not only the generics industry, but for the healthcare industry overall. As generic medications fill over 80% of all prescriptions in the U.S., it is clear that as the generic industry goes, so goes healthcare in the U.S. This close linkage between the two makes the issues facing generic manufacturers critically important – not just to generics companies, but to all of us who rely on their products to provide high quality, cost effective alternatives to their branded counterparts.
This year’s Annual Meeting was especially significant as it marked the 30th anniversary of the Hatch-Waxman Act, the act that paved the way for generic competition. Since that time, generics manufacturers have generated trillions of dollars in savings for the U.S. healthcare system. And yet, with this said, it is clear that generics are a global phenomenon and a global business. The realities of global supply, global quality, different healthcare business models, and emerging patient populations underpinned many of the discussions. It is exciting to think about what the next 30 years will bring as new markets emerge and a truly global healthcare system becomes a reality.
In addition to the global focus, 2014 is shaping up to be a key year for the protection of patient access and affordability. Three of the main topics discussed throughout the day included biosimilars, the implementation of the Generic Drug User Fee Act (GDUFA), and the FDA’s new proposed guidelines for product labeling. It was clear from many of our interactions, as well as a panel discussion, that generics companies are making substantial investments into biosimilar development. And while these drugs are available in Europe today, the challenge in the U.S. market is working with regulators to define a pathway for how these drugs will be approved and brought to market. This will be an important year to meet an agreement, particularly since the number of drugs available as biosimilars could increase substantially over the next several years. In anticipation of this, Clarkston will work with clients in the upcoming year to help round out their portfolio and capacity strategies where biosimilars are concerned.
There were presentations by both Association Members and the FDA’s Acting Director of the Office of Generic Drugs, Dr. Kathleen Uhl, on the implementation of GDUFA. Whereas much progress has been made, there was much discussion of the GDUFA metrics and ensuring that measurement actually leads to progress in the core objectives: increased speed to market and inspection parity. The FDA is undergoing tremendous internal change. It will be no small challenge to implement this change, yet it was clear that all parties are committed to the need to do so and the importance of the desired outcomes. Clarkston anticipates working with clients to help streamline their side of the submission process and create scorecards and perhaps even collaboration tools based on key GDUFA milestones and metrics.
Finally, perhaps the most talked about challenge of the day was the FDA’s new proposed labeling guidelines for generic drugs. These guidelines challenge the very notion of “sameness” that has guided the industry for the past 30 years. Patient safety implications and the introduction of extreme cost burdens could both negatively impact patients and the mission of the generic drug industry. And although there is great time sensitivity around the issue, the Association is clearly in command of the details and galvanized to respond. Regardless of the outcome around this critical issue, Clarkston anticipates working with clients to implement streamlined packaging and labeling review/approval processes and supporting technologies. In the global generics marketplace, this capability will continue to drive differentiation and competitive advantage.
In closing, as in previous years, the GPhA Annual Meeting was yet again an exciting launch pad for the generics industry to address the challenges and opportunities that lie ahead. Check out Clarkston’s Generics Industry Trends Report for further information on many of these challenges and opportunities, as well as ideas for navigating the trends facing generics companies today.