Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions (see herehere and here). On March 14, 2017, FDA made further progress on its Cures Act obligations by releasing in the Federal Register a proposed list of Class II devices that may be exempted from premarket notification (or 510(k)) requirements. The list is currently open for public comment until May 15, 2017.  Under the Cures Act, the final list of exempted devices must be published by July 11, 2017.

Continue Reading Cures Act Developments: FDA Proposes Class II Device Exemptions

Join us next Wednesday, February 15 from 1pm – 2pm Eastern for the final installment of our three-part webinar series on the 21st Century Cures Act (the “Cures Act”).  Part III of the series will focus on the Cures Act’s impact on the FDA and will have some great takeaways for anyone who interacts with the FDA or has an interest in the Cures Act.

In this presentation, our colleagues Bethany Hills and Joanne Hawana will discuss the following FDA-related provisions of the Cures Act and take a deep dive into the practical implications and implementation processes for each of:

  • Regenerative Medicine
  • Medical software/digital health
  • FDA restructuring/structural improvements
  • Health care economic info and off-label communications
  • Data source changes – patient experience, RWE and summary data

Click HERE to register!

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.”  The original Common Rule had been in place for almost 30 years, with little change despite significant research and technology advances during that time.  Further change is on the horizon for the Common Rule, as the 21st Century Cures Act (Cures) includes a mandate for HHS and the Food and Drug Administration (FDA) to harmonize long-standing differences between the Common Rule and FDA Human Subject Protection regulations.    Continue Reading The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

Over the past year, clear trends have emerged in FDA’s enforcement activities. Enforcement arising from alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that can lead to specific administrative actions like product recalls or import detentions, and the pursuit of product seizures using express judicial tools, criminal convictions, or civil settlements in cooperation with DOJ. Structurally, individual compliance offices within the FDA centers and regional offices can initiate enforcement activity against regulated industries, while the FDA Office of Criminal Investigations (OCI) has primary responsibility for criminal investigations conducted by the FDA and works closely with DOJ in setting enforcement priorities for new cases. Continue Reading Health Care Enforcement Review and 2017 Outlook: FDA’s Wide-Ranging Activities

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.

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements. This directive to apply RWE in the drug sphere is particularly interesting because FDA has issued a draft policy on the use of RWE in the context of medical devices, but has generally remained silent about applying RWE to pharmaceutical and biologic regulatory considerations.  In this post, we briefly review the Cures Act’s RWE provision, as well as FDA’s recent public remarks about the use of RWE, and we provide some predictions on how FDA will implement the RWE evaluation program.

Continue Reading 21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

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

On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5.  Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of the U.S. health care system. The Act provides, among other things:

  • $4.8 billion over 10 years to support NIH research on precision medicine, neuroscience, cancer and regenerative medicine.
  • $1 billion in state grants to increase opioid abuse prevention and treatment services, including prescription drug monitoring programs, training programs and treatment programs.
  • Substantial changes to FDA regulations to accelerate the pace of bringing pharmaceuticals and medical devices to market.
  • New obligations on the part of both FDA and industry stakeholders to implement the research initiatives and regulatory changes mentioned above.
  • Other health care initiatives addressing health information technology, vaccines, national security and health care delivery.

At 996 pages, the Act cannot be summarized in one post. Instead, we plan to analyze the various aspects of the Act in multiple posts over the coming weeks. The remainder of this post will highlight provisions that support one of the Act’s primary objectives: the acceleration of drugs and devices to market. Continue Reading Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?

Our colleagues at ML Strategies recently published their Outlook for Fall & Lame Duck, summarizing what to expect from Washington for the remainder of 2016.  The full Outlook is available here, and the portion related to health care is excerpted below.

Congress returns after Labor Day for a four-week sprint that will likely be centered on funding the government by way of a continuing resolution. Since Congress was last in session, the landscape on a number of health care issues remains unchanged. The Senate version of the House-passed Cures package is still in limbo, and mental health reform is no closer to the finish line than it was after the House finally passed its package after months of negotiating. Congress will have an opportunity to advance some issues in September before returning its focus to the 2016 election. After which there will be a, post-election, “lame duck” legislative session – the scope of potential activity for which are uncertain at this point – to put the finishing touches on the 114th Congress. Here’s a look at issues that will likely come up in September: Continue Reading ML Strategies Provides Outlooks for Fall & Lame Duck

The next six weeks are shaping up to be the final work period before the summer recess, with both chambers scheduled to leave DC by July 15th for party conventions followed by the August recess. This makes prioritizing the issues with the best chance of making it to the President’s desk that much more important. While there are several non-health related issues that are already on the schedule, lawmakers are working behind the scenes to make progress on several health issues, with the hope of bringing them up for a floor vote or setting the stage for meaningful action when lawmakers return in the fall. Continue Reading ML Strategies Health Care Congressional Outlook