Don't Forget - the Deadline for Adopting an Expanded Access Policy Under the 21st Century Cures Act is Looming

January 27, 2017 Alerts and Newsletters

As many of you are aware, the 21st Century Cures Act (Pub. L. 114-255) ("Cures Act") was signed into law by President Barack Obama on December 13, 2016.

Under Section 3032 of the Cures Act ("Section 3032"), pharmaceutical companies are generally required to have publicly available policies explaining how the company evaluates and responds to patient requests for certain experimental drugs outside of clinical trials. The deadline for adopting these policies with respect to a particular investigational drug is the later of February 12, 2017 or the first initiation of a phase 2 or 3 study of the investigational drug. For those of you who have investigational drugs that are already in phase 2 or 3, the February 12, 2017 deadline is approaching fast.

Section 3032 requires manufacturers or distributors of investigational drugs for diagnosing, monitoring, or treating serious diseases or conditions to develop and make publicly available (e.g., on the company's website) the manufacturer's policy for responding to requests for so-called "expanded access" use of the drugs. The policy must include the following information:

  • contact information for the manufacturer or distributor for expanded access requests, in order to facilitate communication regarding such requests;
  • procedures for making expanded access requests;
  • the manufacturer's or distributor's general criteria for reviewing and responding to expanded access requests for individual patients;
  • the anticipated length of time for the manufacturer or distributor to acknowledge receipt of expanded access requests; and
  • a link or reference to the clinical trial record included in the clinical trial registry data bank maintained by the National Institutes of Health pursuant to section 402(j) of the Public Health Service Act, which includes a field specifying whether or not there is expanded access to an investigational drug and, if so, how to obtain information about such access.

While manufactures and distributors of investigational drugs must make their expanded access policy publically available, nothing in Section 3032 (or in the Cures Act more broadly) requires these manufacturers and distributors to grant an individual patient's request for expanded access to an investigational drug. Accordingly, an individual patient's expanded access request can be denied for any reason, provided such denial is consistent with the published policy. Additionally, under Section 3032, manufacturers and distributors of investigational drugs are entitled to revise their expanded access policies at any time.

For more information regarding Section 3032, or for assistance drafting your expanded access policy, please contact Andrew Rusczek.

This communication is intended for general information purposes and as a service to clients and friends of Verrill Dana, LLP. This publication, which may be considered advertising under the ethical rules of certain jurisdictions, should not be construed as legal advice or a legal opinion on any specific facts or circumstances, nor does it create attorney-client privilege.

Firm Highlights


High-Profile Former U.S. Department of Justice Prosecutor, David Lazarus, Joins Verrill’s Health Care and Life Sciences Practice

(November 29, 2021) – Verrill is pleased to welcome David Lazarus to the firm’s Boston office as a Partner in its nationally recognized Health Care & Life Sciences Group. Lazarus is a former Department...


Verrill Adds Lead Prosecutor On Insys Case To Boston Office- Law360

On November 18, 2021 Law360 published the article "Verrill Adds Lead Prosecutor On Insys Case To Boston Office," featuring David Lazarus , a recent addition to the Health Care and Life Sciences group at...


James Roosevelt, Jr. Published in ScienceDirect

Verrill attorney James Roosevelt Jr. was published in the February 2022 volume of ScienceDirect , a scientific, technical, and medical research publication. His article “A Federal Indian Health Insurance Plan: Fulfilling a Solemn Obligation...


How Growing Cyber Scrutiny Affects Corporate Compliance

Verrill attorneys David Lazarus , Michael Fee , and Jeffery Smagula authored an article published in Law360 on December 3, 2021 entitled "How Growing Cyber Scrutiny Affects Corporate Compliance." In the article Lazarus, Fee...


The Boston Globe on Federal Prosecutor Joining Verrill


65 Verrill Attorneys Recognized by Best Lawyers® 2022, Including Eight Named Lawyers of the Year

(August 31, 2021) – 65 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2022 , including 8 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer in...


Verrill's Strategic Growth in Key Areas Shared in Mainebiz

On Monday, November 15th Verrill was listed as a Maine law firm who is innovating ways to hire talent in the Mainebiz article "Remote Work Changes Hiring Strategies for Some Maine Law Firms." The...


Pair of Recent Victories Hearten Counsel for MassHealth Providers

Verrill attorney David G. Lazarus was recently mentioned in the Massachusetts Lawyers Weekly article "Pair of Recent Victories Hearten Counsel for MassHealth Providers." The article covers two appellate court decisions regarding the boundaries to...


Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.

Health care attorney Paul Shaw co-authored Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition with Robert Griffith, published by the American Health Law Association (AHLA). Paul and Robert provide legal...

Contact Verrill at (855) 307 0700