Jilting generics: Part 2 of an exclusive interview with GPhA CEO Ralph Neas
The second of a two-part interview with Generic Pharmaceutical Association president and CEO Ralph Neas
Subverting competition in the marketplace is the surest way to kill incentive and introduce inequities. According to Ralph Neas, President and CEO of the Generic Pharmaceutical Association (GPhA), that is certainly the case when it comes to abuse of the Risk Evaluation and Mitigation Strategy (REMS) programs mandated by the FDA.
Last week, Neas told BioPharma Dive how much it costs patients, payers, and society at large when brand-name drug manufacturers unfairly deny access to generic-drug manufacturers, who need brand-name drug samples in order to formulate generic versions of medications and demonstrate bioequivalence.
BioPharma Dive: In part 1 of this series, you commented that $5.4 billion is lost each year from 40 generic small-molecule products whose market entry is being delayed due to REMS abuse. What are potential solutions to this problem?
RN: We believe this issue is best addressed by Congress. Members of Congress are taking note. Curbing REMS abuse remains an important part of any conversation on making sure that generic drugs are able to reach the millions of people that rely on them in a timely manner.
BD: Which members of Congress have taken a strong stance on this issue?
RN: Two in particular have taken a strong stance: Senator Richard Blumenthal, a Democrat from Connecticut, and Congressman Steve Stivers, a Republican from Ohio.
Following are comments from members of Congress about the abuse of REMS as it relates to stifling generic competition.
Senator Richard Blumenthal (D-Connecticut)
"While ensuring the safety of both brand and generic pharmaceuticals must remain a top priority for the FDA, this study [The Matrix Global Advisors Study] raises serious concerns about whether safety protocols are being inappropriately used to inhibit access to cheaper alternatives. Unnecessary delays in market entry inherently mean increased costs to health care consumers, which is simply unacceptable. The potential savings that this study suggests must be considered as we in Congress continue to work to slow health care spending."
Congressman Steve Stivers (R-Ohio)
“We cannot afford to promote waste of taxpayer dollars. A new study shows that some companies are misusing current FDA restricted access policies for certain drugs, resulting in billions of dollars in lost savings for Americans. According to Matrix Global Advisors, some programs that were designed to protect patients are being used as a tool to delay market competition -- costing Americans $5.4 billion annually, including a lost savings of $1.8 billion for the federal government. This problem must be addressed to close loopholes that are costing the government billions of dollars and delaying less costly options for patients.”
BD: Is there anything else that you think is relevant?
RN: Allowing these kinds of abuses to continue unabated can be expected to have a major negative impact on savings from biosimilars once the FDA begins approving biosimilars -- the next frontier of innovation. The data reveals that allowing these practices to go unchecked will have exorbitant and spiraling costs. Delaying biosimilar entry by restricting access to samples would result in approximately $140 million in lost savings for every $1 billion in biologics sales.
These critical medicines have increasingly become the standard of care for many serious conditions, accounting for $92 billion of U.S. drug spending in 2013. This could mean tens of billions more in lost savings in the future.
- Generic Manufacturers Association Matrix Global Advisors Study
- BioPharma Dive Jilting generics: Part 1 of an exclusive interview with GPhA CEO Ralph Neas