On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs.

The speech made pointed attacks on “the middlemen” and drug lobbyists. President Trump even called out Secretary Azar’s past role as a drug company executive when calling out drug companies’ role in high drug prices. Continue Reading President Trump Delivers Much Anticipated Drug Pricing Speech

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.

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.

Last week, Mintz Levin released an Advisory reminding holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) of the February 14, 2018, deadline to submit data to the U.S. Food and Drug Administration (FDA). The Advisory summarizes the notification requirements as well as the risks associated with failing to provide the required information, including removal of a manufacturer’s drug products from the active section of FDA’s Orange Book. The data submission requirements are part of the FDA Reauthorization Act (FDARA), which aims to improve FDA’s ability to track drug products in the commercial marketplace and represents one of Congress’ attempts to control drug pricing and address patient access issues for prescription drugs.

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products.

After the Supreme Court issued its first ruling on the BPCIA in June 2017 (see our prior post here), it sent the dispute between Amgen and Sandoz back to the Federal Circuit Court of Appeals to resolve the question of whether Amgen’s claims asserted under California law, including a claim of unfair competition, were preempted under the BPCIA. Continue Reading Biosimilar Market Developments Continue Apace in 2018

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments.  For those of us who monitor the Food and Drug Administration (FDA or the Agency) and counsel FDA-regulated entities, it has certainly been a whirlwind of a year.

2017 began with no clear picture of who would be assuming leadership of the Agency, but also with a brand-new piece of critically important (and bipartisan!) legislation – the 21st Century Cures Act (see our prior posts here) – which imposed new obligations and authorities on FDA that needed to be implemented, operationalized, and fully funded.  In early May, Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of FDA and he moved quickly to shift policy priorities in almost every area that the Agency regulates, a goal that in some ways was made more efficient due to the concurrent timing of modernization mandates imposed by the Cures Act.  This year’s must-pass User Fee Act, the FDA Reauthorization Act or “FDARA” (see our prior posts here) engendered some hand-wringing and political drama over the summer, but was ultimately passed by Congress in August and signed into law.  FDARA includes some important policy and programmatic changes for new prescription drugs/biologics, generic drugs, and biosimilars, but it did not contain major wholesale reforms to the Agency’s authorities due to the very recent passage of the Cures Act.

This is the first in a series of three installments that will review the actions FDA took in 2017, reflect on what they may mean for regulated industry, and provide a few predictions for 2018.  This first installment, which will be broken up into two posts, focuses on therapeutic products; that is, drugs, biologics, human cells and tissue products, and gene therapies.  Our subsequent posts will focus on medical devices and diagnostics, including whole-genome sequencing tests, and digital health and other software-related developments, respectively. Continue Reading FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) seeks to address Part D drug prices. CMS proposes making certain changes that might lower drug costs (for Plan Sponsors and beneficiaries) and requests information regarding avenues to potentially lower Medicare beneficiaries’ point-of-sale drug costs. The three provisions in the Proposed Rule that most directly relate to drug pricing address: (1) generic drug formulary placement, (2) cost-sharing for follow-on biological products, and (3) whether and how to reduce point-of-sale drug prices based on manufacturer rebates and pharmacy price concessions that a Plan Sponsor might receive months after the beneficiary receives the drugs. We will concentrate on the first two provision in this post. The third provision, which is a request for information, will be discussed in a later post.  Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the Federal Register on November 28, 2017.

The proposed rule focuses on many issues including but not limited to:

  • Implementing certain parts of the Comprehensive Addiction and Recovery Act of 2016, aimed at establishing additional methods that Part D plans can use to reduce abuse or misuse of frequently abused drugs;
  • Changes to certain Medicare Advantage provisions relating to marketing and delivery of information;
  • Establishing “preclusion lists” under Medicare Advantage and Part D to limit when a Medicare Advantage organization and Part D plan sponsor may pay for a service or drug based on the provider who prescribed or furnished the service or drug;
  • Part D Network requirements relating to any willing provider, including defining mail-order pharmacy;
  • Part D beneficiaries’ access to generic drugs and follow-on biological products;
  • Changes to medical loss ratio calculation and reporting; and
  • Updates to the Medicare Advantage and Part D Star Rating System.

Within the proposed rule, CMS also included a request for information regarding the application of manufacturer rebates and pharmacy price concessions to drug prices at the point of sale. CMS has been gathering information regarding this topic for a number of years but appears to be seeking more detailed information in this request.

In the coming weeks we will be issuing detailed posts on these topics as well as others.

Based on the significance and number of the changes proposed, we anticipate that CMS will receive many comments from all segments of industry and beneficiary groups that may be affected by the proposed changes.  Comments are due to CMS before 5:00 pm on January 16, 2018.

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and U.S. Food and Drug Commissioner Dr. Scott Gottlieb will give the keynote addresses. Part of the goal of the workshop is to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs to consumers.

The Hatch-Waxman Act (the Act), which Congress passed over 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has helped reduce patent-related barriers to generic drug entry, which, in turn, has increased competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act. Continue Reading Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.  In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President’s directive. On September 8th, the FDA issued seven Requests for Information that solicit “broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations.” As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.

This post outlines the backdrop for–followed by the details of–FDA’s public request for input about which regulations should be cut or modified. Continue Reading FDA Takes First Steps to Cut Regulations, Solicits Public Feedback