In September, the Generic Pharmaceutical Association announced the appointment of Ralph Neas — former president and CEO of the National Coalition on Health Care — as its new president and CEO, replacing Kathleen Jaeger, who stepped down as president and CEO of the organization in May 2010. Drug Store News recently spoke with Neas about his plans and vision for the organization and the industry as a whole.
DSN: Your predecessor, Kathleen Jaeger, was from the industry, as a former pharmacist. How do you plan to draw from your background in civil rights during your tenure at the GPhA?
Ralph Neas: Prior to joining GPhA, I had the opportunity to work on healthcare issues going back to my days with Republican Sens. Edward Brooke and David Durenberger. In addition, I have had the privilege of serving as the CEO of two of the largest and most diverse coalitions in the nation, the Leadership Conference on Civil Rights and the National Coalition on Health Care. Those experiences taught me about coalition building and how to work collaboratively to achieve a bipartisan consensus on important national issues. Additionally, they provided extensive opportunities to be an advocate before the legislative branch, the executive branch and the media. Hopefully, my training in how to frame a debate and define an issue will be an asset in my new job and help make GPhA a more proactive, aggressive and effective association.
DSN: With the departure of Teva Pharmaceutical Industries and the longer exclusivity period for biotech drugs before they face competition from follow-on biologics than your group had hoped for in the Affordable Care Act, how do you plan to guide the GPhA going forward?
Neas: Teva has rejoined GPhA and is playing a leading role as a member of both our board of directors and executive committee. After the Federal Trade Commission recommended zero years — and the administration had recommended seven — for the exclusivity period for biotech drugs, it was a major and inexplicable disappointment for Congress to pass a 12-year period of exclusivity. I believe that a massive and effective public education campaign can change the current situation and also help create a workable pathway to biogenerics. If something is not done, I fear that exponential growth of biologics over the next 10 to 20 years, without adequate generic alternatives, could bankrupt the healthcare system and the national economy.
DSN: What do you see as the greatest challenges facing the generic drug industry right now?
Neas: As I mentioned, one of the biggest challenges we face right now is ensuring that a workable approval pathway for biogenerics is implemented by the [Food and Drug Administration]. It is critical that the approval process is not fraught with unnecessary and unwarranted roadblocks, such as mandatory clinical trials or repetitive exclusivity periods. ...
It is also vital that the FDA and the Office of Generic Drugs receive adequate funding so that consumers continue to have access to safe and affordable generic medicines in a timely manner. Along those lines, we have just completed a historic generic user fee agreement that will provide the agency with nearly $300 million in additional funding each year. We must make sure that this added funding is used to alleviate the current backlog of pending generic applications and conduct additional foreign inspections.
In addition, we must continue to work to stop any kind of restriction on patent litigation settlements. The fact is that these settlements do result in earlier access to generic medicines and allow generic manufacturers to have date-certain launches of their products.
DSN: What do you see happening in the industry over the next several years?
Neas: No one knows for sure, of course. But it is likely we will see continued consolidation through mergers and acquisitions in both the brand and the generics sectors — and not just generics manufacturers buying other generics companies or brand companies merging with each other. Rather, we could see more companies emerging in the Novartis model, where brand and generics businesses exist within the same company.
As I mentioned before, we will certainly also begin to see an increase in the presence of biogenerics. And after emerging from the forthcoming patent cliff, generic utilization likely could top 80%. ...
DSN: How do you plan to deal with various attempts to ban patent settlements?
Neas: We believe we can defeat attempts to ban patent settlements by sharing the facts with legislators and the public about how these agreements are, in reality, pro-consumer and pro-competitive. Patent settlements have provided millions of consumers with access to affordable medicines far earlier than if they were forced to wait for a branded product’s patents to expire, and in the process have saved consumers hundreds of billions of dollars.
If there are any patent settlements that are not pro-consumer, the Federal Trade Commission and the Department of Justice currently have the authority to challenge such settlements in court. What the FTC is attempting now would overturn nearly a century of intellectual property law and undermine an effective legal remedy that has benefitted millions of consumers.