Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned out, and some entities have been the target of aggressive enforcement actions and even criminal prosecutions by the FDA/Department of Justice. Suffice it to say, this blog post cannot capture everything that compounders have been grappling with or how their compliance policies have been evolving. So today, we are sharing one important and positive bit of news for health systems and other entities that may be considering whether and how to set up an outsourcing facility under Section 503B of the Food, Drug, and Cosmetic Act (as amended by the DQSA). Continue Reading FDA Alters Course on Definition of Compounding “Facility” in Final Guidance

Next Tuesday, January 12th, Mintz Levin and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”).  The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.

Join my Mintz Levin and ML Strategies colleagues Tom CraneEllen Janos, and Rodney Whitlock, and moderator Bethany Hills, as they provide an introduction to the Cures Act.  Specific topics for this first webinar will include:

  • The political path taken to accomplish the Act, the compromises made, and the key implementation issues facing the Trump administration
  • Health information policies related to Electronic Health Records
  • Medicare delivery reform, coverage/payment changes, and OIG authorities
  • Mental health parity and new funding opportunities for substance use disorder prevention and improved mental health access and services
  • The “sense of Congress” on telehealth expansion and changes to HIPAA

Click here to register!  For more information on the Cures Act check out our prior blog posts covering provisions related to: (i) the role of Real World Evidence; (ii) the accelerated approval pathway for regenerative medicine; and (iii) drug and biologic manufacturers’ ability to promote their products to payors and health plans through well-developed “health care economic information.

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law.  The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises. Our colleagues have previously discussed the Act’s many provisions that aim to speed up the process of bringing new drugs and devices to market. One of the Act’s most significant amendments to the Federal Food, Drug and Cosmetic Act will allow FDA to grant accelerated approval to regenerative medicine products, while also providing the Agency with wide discretion on creating new approaches to regenerative medicine. This legislative development is historic given increasing pressure from patients and other stakeholders to move regenerative medicine advancements more quickly from the lab into the clinic. Continue Reading President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products.

First, however, a little bit of historical context might be helpful.  As previously reported here and widely known in health care circles, in late 2013 Congress passed a law called the Drug Quality and Security Act (DQSA).  Among other things, DQSA created a new class of federally regulated drug compounders called “outsourcing facilities” and also clarified requirements for compounding by licensed pharmacists and physicians in compliance with the Federal Food, Drug, and Cosmetic Act.  In the 2.5 years that have elapsed since enactment of the law, FDA has been busy implementing its new authority over outsourcing facilities and issuing guidance for those entities, such as how current Good Manufacturing Practice (cGMP) regulations will apply to them and how they should go about registering and paying a required annual establishment fee. The three draft policies issued in mid-April address issues that affect both outsourcing facilities and State-licensed pharmacies that compound drugs on behalf of health care practitioners who need customized, non-commercially available products for specific patients.  The policies address, for example, what constitutes a “prescription” for a compounded drug; how much product can be prepared in anticipation of receiving future prescription orders; and how large hospital or health system pharmacies may distribute compounds to other areas of the facility in advance of receiving a patient-specific order. Continue Reading New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

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 ClinicalTrials.gov database.  ClinicalTrials.gov 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 http://www.ClinicalTrials.gov, 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.