Generics continue to grow as a proportion of the total prescriptions dispensed every year, and as that number has grown, so have the savings that generics bring to the healthcare system. The Generic Pharmaceutical Association has been front and center, touting the benefits that generics bring for lawmakers, payers and, most importantly, patients. Drug Store News spoke with GPhA president and CEO Chip Davis about the organization’s efforts in 2016 and plans for the remainder of 2017.
DSN: With 2016 in the rearview mirror, what are some of the biggest legislative victories for the generics industry last year?
Chip Davis: Generic drug and biosimilar manufacturers are pleased to see momentum for the bipartisan CREATES Act. This bill is a widely supported effort that would stop brand drug companies from blocking generic drug competition. While there is much debate on the drivers of high health costs, experts agree that one solution is to encourage pharmaceutical competition from generic drugs.
DSN: With the passage of the 21st Century Cures Act last year, what elements were good for the industry, and what work is left to do on elements that were left out?
Davis: GPhA recognizes this bill is a bipartisan achievement that should spur innovation and benefit patients. Notably, the package includes important funding to support the Comprehensive Addiction and Recovery, [or] CARA, Act, which will help address the public health crisis surrounding prescription drug abuse. We urge Congress to expeditiously pass this bill.
While the 21st Century Cures Act … does not include provisions GPhA supports to increase prescription drug pricing competition, we will continue working with Congress to find solutions to rising drug costs that bring safe and effective generic drugs to market more quickly and ensure more patients and payers have access to them. Toward that end, GPhA will continue to support and seek enactment of the bipartisan CREATES Act, sponsored by Sens. Grassley, Lee, Leahy, and Klobuchar, and the FAST Generics Act, sponsored by Reps. Stivers and Welch.
DSN: You recently wrote a letter to then-President-elect Donald Trump — what are the key policy prescriptions that the GPhA would like to see a focus on as his administration gets started?
Davis: Generic and biosimilar medicines are a ready-made solution to high drug costs. Unleashing the full potential of these medicines will require a bipartisan effort that includes patients, pharmacists, doctors, payers, supply chain partners and others, who rely on access to safe, effective and more affordable medicines. It is important that policymakers pursue patient-centric and market-based solutions that enhance competition and expedite generic market entry to bring down prices and improve patient access to medicines.
Generic drugs are 89% of prescriptions dispensed in the United States, but are only 27% of total drug costs, according to the GPhA/Quintiles IMS Institute Generic Drug Savings and Access report. This means hundreds of billions in annual savings for our healthcare system, a foundation to build upon, not to inhibit or put at risk.
To that end, GPhA supports five policy prescriptions that would increase competition and make safe, effective and more affordable medicines more accessible to all Americans:
1. Promote timely access to quality affordable generic drugs that meet high standards of a streamlined development and approval process.
2. Create policies that recognize the different economic dynamics of the brand and generic markets.
3. Ensure an intellectual-property framework that balances the need for innovation and robust generic competition.
4. Stop some brand companies from blocking or delaying generic drug development.
5. Increase utilization of affordable generics across all patient populations.
DSN: One of the pieces of legislation GPhA has championed is the Creating and Restoring Equal Access to Equivalent Samples, or CREATES, Act — given the recent report on drug pricing from the Senate Committee on Aging that called for better access to samples for generics makers, do you see 2017 as a more fruitful year for the legislation, and how could it help speed up generics development?
Momentum for the bill continues to build, and we look forward to timely re-introduction during the next Congress. There is widespread support from all corners of the pharmaceutical supply chain, patient groups, health professionals, payers and others interested in ensuring access to more affordable medicine.