On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.

Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application.  Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

As we gear up for a busy week in Washington, D.C., our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes upcoming hearing on safety net health programs and prescription drug costs along with the progress of the American Health Care Act.  Stay tuned for additional updates and analysis from ML Strategies.

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by as much as $1.27 billion, “far more” than the announced-but-never-confirmed or finalized $465 million DOJ settlement with Mylan.

To understand what the latest news means in the ongoing saga over EpiPen Medicaid Drug Rebates, it is important to understand how we got here.   And why at the end of the day, the information Senator Grassley included in the May 31, 2016 release may be less important than the information he hinted at but omitted from the release. Continue Reading The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical companies for the high prices of their products but has done little to advance concrete policies in this area.

Dr. Gottlieb has been consistent over the years, including during his recent confirmation process, in his view that FDA should take a more active role in fostering competition and reducing unnecessary regulatory barriers. So it was not surprising when he was selected by Trump to lead the Agency, nor when he received a relatively warm welcome from Senators concerned about the direction prices have been going in recent years. Continue Reading FDA Commissioner Hints at Drug Pricing-Related Initiatives

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance.  CMS implemented the controversial guidance as a final rule in October 2016.

The current policy requires all biosimilars that are related to a reference product to be given a shared Healthcare Common Procedure Coding System (HCPCS) code. For Medicare Part B, reimbursement is then calculated based on the average sales price (ASP) of all of the biosimilars with that HCPCS code plus 6% of their reference product’s ASP. Continue Reading CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934.  The committee voted almost unanimously to move the bipartisan bill forward, with only Senator Bernie Sanders (I-Vt.) and Senator Rand Paul (R-Ky.) voting against it.  And in an interesting overlap of FDA-related news, the Agency’s brand-new Commissioner, Dr. Scott Gottlieb, was also sworn in on May 11th following a speedy (albeit politically controversial and party-line) confirmation process and Senate vote.  With less than a week on the job, Dr. Gottlieb is already receiving pressure from varied stakeholders to ensure the user fee legislation is enacted in a timely manner in order to avoid disrupting the Agency’s work. Continue Reading FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy might end up a few years from now. This post focuses on the history of FDA’s off-label communication and promotion policy, and while it is by no means a comprehensive history, I attempt to reveal some of the origins and early development of the Agency’s approach to off-label uses and promotion.  In fact, FDA’s early position on off-label communications closely resembles the Agency’s stance on the subject today. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging.  As we previously reported, a discussion draft of the FDA Reauthorization Act was released jointly by leaders of the Senate HELP Committee and the House Energy & Commerce Committee two weeks prior to that comment deadline.  It now seems that the late start to the 2017 user fee legislative process – along with the rapid approach of summer and the risk of Agency layoffs if this five-year reauthorization cycle is not completed before August – has gotten everyone pushing on the accelerator a bit. Continue Reading More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation

Patient assistance programs have been a staple within the health care industry for over a decade.  These programs, operated by 503(c)(3) charities, may receive funding from pharmaceutical manufacturers or other providers to offer assistance to low-income patients in affording their medications, copayments, deductibles, premiums, or other related services.   The Office of the Inspector General (OIG) and the Centers of Medicare & Medicare Services (CMS) have acknowledged the role of provider- and manufacturer-supported charitable premium assistance and have established parameters for these charities to operate in compliance with the Anti-Kickback Statute.

Over the last two years, however, government scrutiny and enforcement related to charitable patient assistance programs has increased.   During this time, nearly a dozen pharmaceutical manufacturers and providers have publicly disclosed receipt of government subpoenas investigating their contributions to patient assistance charities.

These new investigations raise a number of questions when it comes to structuring relationships with patient assistance programs.  On May 16th, we will be holding a webinar to review these current investigations and outline what providers, payors, pharmacy benefit managers (PBMs), and pharmacies working with manufacturers and patient assistance programs need to know in light of these investigations.

We hope you join us!  For more information and to register for this webinar, please click here.

shutterstock_428983732Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315.  AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from the Board of Pharmacy, (b) to state that PBMs have fiduciary duties to their “purchaser” clients (i.e., health plans), and (c) to require PBMs to disclose to their purchaser clients data regarding drug costs, rebates, and fees earned. The favorable vote moves the bill to the Committee on Appropriations.

California is not the only state that is considering adopting a PBM “transparency” law.  New York’s Governor Cuomo released a proposal that seeks to require PBMs to both register with the State and obtain a license (from the Department of Financial Services) as well as disclose financial incentives or benefits for promoting the use of certain drugs and financial arrangements that affect customers.  The Governor would also like to impose price controls on pharmaceutical manufacturers.  New York has a long history of regulating PBMs through a handful  of systems because the services that PBMs offer often result in a PBM needing to hold a specific non-PBM license and to adopt a specific corporate structure.  In addition, Senator Wyden (D-Ore.) introduced the C-THRU Act to the Senate Finance Committee in March.  The C-THRU Act seeks to make PBM rebate data publicly available, require the Secretary of HHS to adopt a minimum percentage of drug rebates that a PBM would need to pass through to certain of its health plan clients, and amend the definition of “negotiated prices” under the Medicare Part D Program.  Continue Reading California Advances PBM Licensing and “Transparency” Law