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

Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc.  The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts as part of the patent dispute with the manufacturer of the reference biologic, Remicade (infliximab), Janssen Biotech.  At the end of the day, CT-P13 – which would be the first monoclonal antibody approved under the FDA’s biosimilar program – received the support of Arthritis Advisory Committee members. The outcome of yesterday’s hearing in the patent litigation remains unknown.  When factual issues are not in dispute, FDA typically follows the advice of its expert advisory committees on approval and/or restrictions on new products, so we expect final approval of the Celltrion product in the coming months.   Remicade is a blockbuster drug, with estimates of over $4 billion in sales annually in the U.S. alone, so the anticipated approval of a biosimilar version of infliximab has significance for health care providers, payors, and patients as well as investors.  Our colleague Tom Wintner talks more about these developments today on the Global IP Matters Blog, available here.

For further developments in the biosimilars arena tune in to the Mintz Levin biosimilars webinar series (register here), the next installment of which is taking place on February 25 at 3pm ET.

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary names for biosimilars as compared to their reference biologics would signal clinically meaningful differences to already-confused physicians. The end result would reduce not only biosimilar substitution but also the incentive for aggressive price competition between reference biologics and follow-on biosimilar products.  In its written comments to FDA, the FTC argued that a naming convention akin to FDA’s small molecule policy would encourage lower-cost biosimilar price substitution by maintaining consistency for prescribing physicians. Continue Reading FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products. The Agency published notice of its draft guidance on August 28th in the Federal Register, along with a proposed rule to assign new proper names to some already approved biologic products, including the only biosimilar product licensed so far under the abbreviated 351(k) pathway.

The industry has been waiting for some time for FDA’s policy position on nonproprietary naming of biological products, particularly for biosimilars and interchangeable biosimilars. With its position only partially decided in the draft policy, as described further below, the wait will go on while industry players continue advocating their positions to the Agency during the comment period.

So, what has FDA proposed?

In order to avoid inaccurate perceptions regarding the safety or effectiveness of biological products based on their licensure pathway – whether an original biologics application or an abbreviated biosimilar application – FDA has determined that the naming convention will apply to all biological products both prospectively and retrospectively. Per the draft guidance, all biological product nonproprietary names would consist of a core name and a designated four-letter suffix.  This convention will permit products with the same core name to be grouped together in electronic databases and systems, a benefit that would not be possible through use of a prefix. Continue Reading FDA’s New Four-Letter Guidance on Biosimilars

Drug Shortage Reporting RulesEarlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological products to FDA. The final rule requires enhanced reporting to assist FDA in preparing for and preventing drug shortages, and it is largely unchanged from the proposed rule released in November 2013.

The final rule requires holders of approved applications for certain drugs and biological products, as well as manufacturers of drugs marketed without FDA approval, to submit an electronic notice to FDA of a permanent discontinuance or temporary interruption in the supply of a drug or product. Products covered under the rules are those that are i) life-supporting, ii) life sustaining, or iii) intended for use in the prevention or treatment of a debilitating disease or condition. Applicants must make the electronic report to FDA at least 6 months prior to the date of permanent discontinuance or interruption or as soon as practicable, but no later than 5 business days following the event. Failure to notify FDA may result in the issuance and public posting of a noncompliance letter. Continue Reading Final Drug Shortage Reporting Rules Will Go Into Effect September 2015

Written by Dianne J. Bourque

Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information will be entered into the database. is a clinical trial registry maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM).  It lists both federally and privately supported clinical trials and provides up-to-date information about a trial’s purpose, enrollment criteria and other information for both patients and providers for locating clinical trials for a wide range of diseases and conditions.    

The new consent requirement applies to “applicable clinical trials” or trials initiated on or after March 7, 2012, of drugs, biological products or devices that are subject to FDA regulation.  This includes trials conducted outside of the United States that are subject to FDA regulation.  Note that the new requirement does not apply to studies involving only de-identified human tissue specimens.  Clinical trial sponsors and investigators are responsible for determining whether or not a trial is an “applicable clinical trial.”  

The specific statement that must be included word-for-word in a applicable clinical trial consent forms as of today is: 

“A description of this clinical trial will be available on, as required by U.S law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at any time.” 

 FDA has published a guidance document with more information about the new requirement.