Drug pricing controversies continue to dominate headlines. While Congress and the public continue to highlight pharmaceutical manufacturer pricing actions, the last year has seen a shift in focus to the role that payors, PBMs, and pharmacies play in the pharmaceutical supply chain, and their attendant role in drug pricing. This session will explore how drug pricing controversies have impacted or may impact manufacturer, payor, PBM and pharmacy operations from a legal, policy and operational perspective. Topics include:
• Policy pressures facing manufacturers, payors, PBMs, and pharmacies
• Recent Federal and State investigations and legislation impacting payors, PBMs, and pharmacies
• How CMS and the Medicare Part D program are addressing drug pricing issues
• The potential for direct Medicare negotiation of drug prices and rebates
• Potential transparency requirements

As it becomes increasingly difficult to enact and implement legislative and regulatory changes at the federal level, states are increasingly taking an active role in regulating the pharmaceutical and payor industries. This session will explore states’ existing requirements and potential initiatives that impact payors and the pharmaceutical supply chain, including:
• The various state players: Legislatures, Medicaid Agencies, Pharmacy Boards, Insurance Commissioners/Divisions of Insurance, State Attorney Generals
• The existing state laws that may impact industry stakeholders such as PBM and mail order pharmacy regulation and oversight, prior authorization requirements, any willing pharmacy laws, anti-discrimination protections, and Medicaid requirements
• The various types of state initiatives that may be coming down the pike targeting drug pricing and price controls, use of pharmacy coupons, disclosure of rebates and other transparency initiatives, and co-pay caps.

6:00 pm | Cocktail Reception
7:00 pm | Dinner

Without having direct authority over drug prices or rebates, the Food and Drug Administration nonetheless plays a critical role in the prescription drug and biologic marketplaces from many different angles, including setting standards for product safety and limiting what companies can say regarding the comparative effectiveness of their products compared to potential competitors. As a result, FDA receives substantial pressure from legislators, patient groups, and industry alike to contribute wherever possible to mitigating regulatory burdens that are seen as indirectly influencing unsustainable price increases.

This session will comprise a discussion of FDA’s role in the evolving U.S. biopharmaceutical landscape and the impact of recent (and expected) policies on different parts of a complex supply chain, from manufacturers to pharmacies. Topics will include:
• Potential changes to FDA policies or priorities that affect drugs and biologics, as a result of Trump Administration regulatory orders and implementation of the 21st Century Cures Act (passed in December 2016)
• Overview of recent FDA activities regarding Biosimilars, including a view of the current biosimilar marketplace and predictions for the Supreme Court’s first foray into interpreting the Biologics Price Competition and Innovation Act this Spring
• Examination of the Agency’s January 2017 memorandum and draft guidances for industry related to manufacturer communications about unapproved uses of drugs and biologics (i.e., off-label uses), as well as pre-approval communications to payors and formularies
• Prospects for the 2017 User Fee Act Reauthorization Process in Congress, which includes prescription drug, generic drug, and biosimilar UFAs and could be used to enact unrelated new laws, such as giving the Agency mandatory drug recall authority
• And, if known by April 5th, what the new FDA Commissioner may seek to do in his or her first year in charge of the Agency and its drug review and approval processes

Panelists, including participants from the relators’ bar and government, will address the latest developments in federal and state government enforcement actions involving drugs, insurers, PBMs, pharmacies, and manufacturers, including enforcement actions involving:
• Financial relationships, discounts, and alleged kickback violations
• Pharmacy discount programs and alleged usual/customary price violations
• Patient assistance programs and alleged kickback/beneficiary inducement violations
• False claims actions based on regulatory violations post-Escobar