CALL INVITE | DRUG PRICING AND APPROVAL POLICY - IT'S A NEW DAY (JULY 20th @ 11:00 AM ET)

Overview: We hope you will join us for a Black Book presentation on federal and, to a lesser extent, state policy on pharmaceutical pricing and approval. The call will be held Thursday July 20th at 11 am ET. We will be surveilling the administrative, legislative and judicial actions underway in the Trump administration and in select states. While the new administration is certainly more favorably disposed toward the pharmaceutical industry, there will be winners and losers as the FDA and CMS set a new course. Increases in pharmaceutical prices have created a populist issue for Trump but he is avoiding legislative solutions like negotiating Part B or D drugs. Instead administrative action is focused on faster and more approvals of generics, reforming the supply channel, and limiting diversion of spread between gross and net pricing. For its part, Congress is supporting increases in NIH funding and avoiding engagement on the hot button issue of price controls. Meanwhile in the states, efforts are underway to limit "price gouging" and hold manufacturers accountable for opioid addiction crisis. Join us Thursday July 20 at 11:00 am ET Please contact for more information. A link and dial-in instructions will be sent to subscribers before the call.

Major Topics:

• CMS has proposed a reduction in reimbursement for 340B drugs from ASP + 6 percent to ASP - 22.5 percent. We will look at the ramifications to non-profit providers, contract pharmacies like WBA and drug companies.
• The FDA has two major initiatives underway to speed approvals and encourage competition: the Drug Competition Action Plan and the Innovation Initiative. What do those efforts look like and how are they being implemented?
• Trump and the pharmaceutical industry have encourage value-based drug purchasing programs. What barriers need to be overcome (like ASP pricing) and what are the implications?
• Drug importation has bi-partisan support but is opposed by the industry. Who wins that argument?
• Congress has refused to go along with Trump proposed NIH cuts and funding is expected to increase again in FY 2018, what areas of research will be most affected?
• What changes to the user fee agreement can we expect in the Senate? What impact will ACA repeal action have on the mood of preogressive like Elizabeth Warren and Bernie Sanders?
• How are states responding to drug price controversies?
• Will the state AG lawsuit against opioid manufacturers be like the tobacco lawsuits of the 1990s?

And much more...

Call or email with questions and suggestions if you know of a topic that needs to be covered.

Emily Evans

Managing Director

Health Policy

@HedgeyeEEvans