This morning, The Hill hosted an event, sponsored by the Coalition for Affordable Prescription Drugs, entitled, “The Prescription Drug Delivery System: Tackling Costs, Ensuring Access.” The event featured headliners Senator Bill Cassidy (R-LA), Representative Diana DeGette (D-CO), Representative Gene Green (D-TX), and FDA Commissioner Scott Gottlieb. Other speakers included representatives from trade organizations, manufacturers, and pharmacy benefit managers.

Senator Cassidy Highlights Transparency, Thinks Drug Pricing Will Come Separate from Health Reform

At the event, Senator Cassidy touched a variety of issues, discussing transparency and health care reform. When asked about next steps in possible health care reform, Senator Cassidy spoke about giving power back to the patient and to the state, stating that having control over the dollars will give them control. Cassidy suggested dispensing money back to the states with some provisions, like use of health savings accounts.

Senator Cassidy discussed the role of transparency, stating that a lack of transparency can contribute to rising drug prices. He specifically spoke against gag orders that contracts can place on pharmacists in cases where it is cheaper for patients to pay out-of-pocket than to use their benefit. The discussion also included what Senator Cassidy referred to as globalizing the market by allowing the purchase of products made overseas should a lab be certified by the appropriate regulatory agency.

Finally, Senator Cassidy stated that he believes drug pricing will be separate from efforts surrounding the Affordable Care Act (ACA). The Senator stated that these efforts around the ACA are not related to Medicare Part D, which is a player in the drug pricing conversation. Senator Cassidy also mentioned a recent hearing of the Senate Health, Education, Labor, and Pensions (HELP) Committee that discussed drug pricing.

Representatives DeGette and Green Hoping for Hearings, Investigations into High Drug Prices

Representatives DeGette and Green, both members of the House Energy and Commerce Committee, expressed support for holding hearings and conducting investigations into high drug prices. However, both noted that as members of the minority, this can be difficult. In addition, acknowledging that the ACA needs improvement, both highlighted a need for bipartisanship as Congress works towards solutions. When asked about exclusivity and the lifespan of patents, Rep. DeGette stated that a “sweet spot” needs to be found where exclusivity is given for an amount of time that incentives development but is not granted to so long that a company is essentially obtaining a monopoly. Rep. Green also discussed exclusivity as a policy lever that can be used when trying to balance cost, innovation, and access.

Gottlieb Discusses Role of FDA

At the event, Commissioner Gottlieb discussed the role that the FDA can play in tackling drug prices. The Commissioner stated that he sees the FDA working to balance innovation and competition by encouraging the framework set up with the Hatch-Waxman Act. Building off his comments at a public meeting about generic drug competition hosted by the FDA earlier this week, Commissioner Gottlieb indicated that the FDA sees places where their regulations are being taken advantage of to the detriment of competition in the generic market. Highlighting risk evaluation and mitigation strategies (REMS), Gottlieb stated that the FDA wants to have clear and consistent rules in place that prevent these types of situations. Finally, the Commissioner also discussed the FDA’s Drug Competition Action Plan that is trying to address places where these regulations are being taken advantage of as well as looking at the overall generic review process.

Panel

The final portion of the event included a panel that included a variety of stakeholders. The panel was composed of:

• Ceci Connolly- President & CEO, Alliance of Community Health Plans (ACHP)
• Chip Davis, Jr.- President & CEO, Association for Accessible Medicines (AAM)
• Sumit Dutta, M.D.- Senior Vice President and Chief Medical Officer, Optum Rx
• James Gelfund- Senior Vice President, Health Policy, ERISA Industry Committee
• Bill Reid- Senior Director, Global Public Policy and Anti-Counterfeiting Operations, Eli Lilly
• Ellen Sigal- Chairperson & Founder, Friends of Cancer Research

The panelists touched on areas that were within their policy expertise. Chip Davis from the AAM highlighted that generic drug prices have been going down while noting that he believes drug pricing will remain a relevant topic since many people campaigned on drug prices throughout the most recent election cycle. James Gelfund, meanwhile, saw the recent FDA Reauthorization Act efforts as a missed opportunity to discuss drug prices and noted that employers are worried about their rising insurance costs, which includes the costs of drugs. Bill Reid from Eli Lilly looked towards policy solutions like value-based agreements as items that could start impact drug pricing. The panelists all noted the importance of these conversations and the need to balance many competing factors like research costs, innovation, market competition, and access.