GPhA's Ralph Neas on Hatch-Waxman anniversary

Ralph Neas became president and CEO of the Generic Pharmaceutical Association in September 2011, following a long career in public service. He was chief counsel to Republican U.S. senators Edward Brooke and Dave Durenberger in the 1970s, before serving as executive director of the Leadership Conference on Civil Rights, as president and CEO of People for the American Way and as senior adviser to the president of the National Coalition on Health Care.

(Click here to view the full Category Review.)



DSN spoke with Neas in late October to mark the 30th anniversary of the landmark Drug Price Competition and Patent Term Restoration Act — better known as the Hatch-Waxman Act. Here are excerpts from that interview:



DSN: What has the Hatch-Waxman Act meant for both the industry and pharmacy retailers and patients themselves?



Ralph Neas: Hatch-Waxman is one of the more important and effective laws ever enacted in our nations history. It launched the generic pharmaceutical industry. And literally hundreds of millions of Americans and people across the globe now have access to affordable medicines — and that saves lives and enhances quality of life. We now have 86% penetration [of generic vs. branded prescriptions], and the savings have been enormous — $1.46 trillion over the last 10 years, and $239 billion just in 2013 alone.



DSN: What about the law's effect on the branded side of the drug industry?



Neas: As someone who has worked to achieve bipartisan successes on a range of issues, I'm in absolute awe of Sen. Orrin Hatch and Rep. Henry Waxman, and what they and other Republicans and Democrats put together in '84. It's a great example not only of bipartisan compromise, but also of striking a perfect balance. [The law] promotes affordable medicines, while at the same time protecting research and development. We need both.



In the last 10 years, there's been an increase of 40% of new medicines in development. I believe there are 3,400 medicines in development just in the United States. That's also an extraordinary success story. What a spur to competition and innovation Hatch-Waxman has been! And whatever helps both brands and generics means wonderful things for America.



DSN: Where do things go from here for generics?



Neas: The Affordable Care Act is bringing in millions of people who have never been able to afford medicine, and that expanded coverage means a growth in generic usage. But you've also got the “Silver Tsunami” now — tens of millions of baby boomers using more medicines, especially generics. And you've got globalization ... with more and more access to markets around the world. And of course the new frontier is biosimilars.



DSN: What growth potential do you see for biosimilars?



Neas: According to Express Scripts, if you had biosimilars for just the top 11 biologics, there would be $250 billion in savings over the next 10 years. The patent cliff with respect to biologics is just starting. This is a very exciting moment in terms of where we are with affordable medicines.



DSN: It looks like the Food and Drug Administration logjam in creating a review and approval pathway might be starting to break up with the first biosimilars accepted for review.



Neas: Yes. There are now two applications before the FDA. Biosimilars have been in 50 countries for eight or nine years. When Americans figure out how many countries have already been using them, they're going to ... [demand] access. So it’s definitely a growth market that's ready to take off.



DSN: What is GPhA doing to encourage that growth in biosimilars?



Neas: The pathway was approved in 2010, and we're working closely with the FDA to make sure that continues to move forward. And also to hopefully protect the biosimilar naming and exclusivity issues on biologics ... with respect to making sure the implementation of legislation within the states goes forward without hurdles. It's a big agenda. But we've been very fortunate, especially in the last couple of years, in winning a lot of victories.



DSN: Out-of-pocket costs for prescriptions are one factor that has kept nonadherence levels high among patients in the United States. What impact do you think generics are having on medication adherence?



Neas: You know how many lives are lost every year because people do not take their medications regularly, and many times it's because they cannot afford them. Study after study shows that lower-cost generics are associated with improved adherence. I believe more and more people are becoming familiar with that aspect of what generic medicines provide.