This week, focus turns to the Senate as the House overwhelmingly passed its opioid package known as H.R. 6 last week (see our previous coverage here). The Senate will look to combine its various proposals into one package for floor consideration and what passes will provide a timeline for reconciling the House and Senate packages. In other news, the Senate will spend time in the HELP and Finance Committee on drug pricing. With Secretary Azar set to testify, we look for signals that the Administration is moving forward with any aspect of its drug pricing blueprint. We cover this and more in this week’s preview, which you can find here.
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process. Today we’re going to recap some of what has transpired over the past 5 months in the biosimilars space in an attempt to get our readers caught up. Continue Reading Biosimilars in the Limelight – A Lot Has Happened Since January 2018
Congress will continue its work in addressing the opioid crisis this week with a hearing in the Senate Finance Committee. There were reports last week that Congress will also consider legislation around telemedicine, which is sure to capture stakeholders attention. The Administration is also going to take another look at drug pricing which is setting the stage for another busy work period. We cover this and more in this week’s preview, which you can find here.
Mintz Levin and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year’s summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker. The Summit brings together stakeholders and thought leaders to discuss current hot topics facing manufacturers, PBMs, payors, pharmacies, and other providers. This year’s Summit will include sessions on:
- The evolving drug supply chain – distruptor models and the Amazon effect
- Addressing drug pricing and supply chain economics – government investigations and ERISA litigation
- The uncertain state of the 340B program
- Government enforcement targeting financial relationships
- Combatting the opioid crisis
For additional information on the Summit, including the full agenda and registration information, please visit our event website.
Although the options for accelerated FDA pathways have recently expanded, the current political climate has increased scrutiny of expedited approvals. Next week, my colleague Bethany Hills will be moderating a panel discussion in our Boston office about the realities of pursuing an accelerated pathway. Panelists from J&J Innovation, Synlogic, and Analysis Group will focus on the risks and potential rewards of the shorter time to market.
Topics to be covered include:
- When to consider an alternative pathway to approval
- Risks – including the chance of FDA denial
- Market perceptions — increased value, rising stock prices
- Realities of the pathways
- Clinical and data risks
- Pairing exclusivity and accelerated pathways
- Finance theory on risk and stock pricing
The event will take place next Thursday, March 29th at 5:00 PM in our Boston office (registration starts at 4:30). For more information or to register or the event, please click here.
Congress has until Friday to finalize a government spending bill. Over the next couple of days it will decide whether to move forward with a number of consequential health care issues, market stabilization and drug pricing chief among them. There is also the possibility of movement around short-term health plans. We cover this and more in this week’s health care preview, which can be found here.
This week, Congress returns to Washington with 11 days to finalize a government spending bill. Standing in the way are a number of unresolved health care issues, including drug pricing and market stabilization. There are a number of moving parts that will begin to come together this week. Also on our radar screen is the ongoing marketplace issues in the state of Idaho, where the federal government is urging the state to consider short-term limited duration insurance plans. We cover this and more in the health care preview, which you can find here.
This week, the President’s FY 2019 budget will be released, and the Administration will spend the next couple of weeks touting its goals. How this activity is received in Congress will play out in various committee hearings, as will issues like drug pricing, which the Administration is closely examining. On the regulatory side, is this the week that we finally see action on short-term limited duration insurance plans? We cover what that could mean and more in this week’s health care preview.
On Monday, November 13, our colleagues in the Antitrust Section published an alert on the recent FTC workshop, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop, which was held on November 8, 2017, began with two keynote addresses from FTC Acting Chairman Maureen Ohlhausen and FDA Commissioner Dr. Scott Gottlieb. Both speakers focused on the beneficial effects of greater competition on prescription drug prices and signaled that the branded drug manufacturers may be discouraging generic drug manufacturers from entering the market. However, Acting Chairman Ohlhausen stated that any FTC antitrust enforcement actions in this space will be based on the specific facts of a case rather than a broad-based action against particular industry practices.
The alert goes on to summarize the content of each of the four workshop panels:
- Panel 1: Generic Drug Competition: Understanding Demand, Price and Supply Issues
- Panel 2: Understanding Intermediaries: Pharmacy Benefit Managers
- Panel 3: Understanding Intermediaries: Group Purchasing Organizations
- Panel 4: Potential Next Steps to Encourage Entry and Expand Access Through Lower Prices
Click here to read the full summary of the FTC workshop.
Last week, ML Strategies released an Advisory providing a comprehensive review of the sweeping health care legislation recently released by the Massachusetts Senate. The Advisory summarizes the notable provisions contained in the bill, including, among other things, how to handle the rising cost of prescription drugs, hospital reimbursement rates, changes to MassHealth (the Massachusetts Medicaid agency), and commercial insurance market tiering. The bill represents the latest in a series of proposals lawmakers and the Baker administration have made this year aimed at lowering health care costs and improving quality of care. Given the uncertain future of health care at the national level, all eyes will be on Massachusetts as it grapples with these important issues.