Client Alert: Newly-Passed 21st Century Cures Act -- Immediate Action Might Be Required
The 21st Century Cures Act was enacted on December 13, 2016. It is a complex and comprehensive law that will impact most companies engaging in healthcare R&D activities.
Below is a brief summary of the 21st Century Cures Act, and an explanation of a provision under the Act that requires immediate attention by manufacturers or distributors of investigational compounds being studied for the diagnosis, monitoring or treatment of certain identified serious conditions. The deadline for complying with the new provision under the Act could be as early as February 8, 2017.
If you have any questions about how the 21st Century Cures Act might impact your business or how we can assist you in complying with new requirements under the Act, please contact your primary contact with the firm or Robb Giddings at 352-474-5335 or rgiddings@hutchlaw.com.
Summary of 21st Century Cures Act:
Although the 21st Century Cures Act addresses topics in addition to healthcare R&D, this summary focuses on the impact the Act is likely to have on healthcare R&D companies.
Overall, the Act is designed to facilitate improvements in healthcare R&D by:
- Increasing agency funding, which will likely increase the amount of funds available to companies that further the agencies’ missions and initiatives;
- Fostering increased collaboration among government agencies and industry;
- Prioritizing research, government support and/or government programs in certain indications (oncology, neurology, brain research, mental health, precision medicine, pediatrics, pregnant women and lactating women, medical countermeasures for national security risks and tick-borne diseases);
- Reducing regulatory hurdles and uncertainty related to drug, biologic and device R&D; and
- Accelerating regulatory review and approval of drugs, biologics and devices.
Few provisions under the 21st Century Cures Act require immediate action as most provisions will not be fully-implemented for months or years. The provisions that do take effect quickly can, for the most part, be navigated in the future (primarily, when collaborating with a federal agency or making a regulatory submission to the FDA). However, at least one of the Act’s new provisions requires immediate attention by drug and biologic companies to ensure that they remain compliant with the Act.
Manufacturers/Distributors of Investigational Compounds for Serious Conditions Must Publish An Expanded Access Policy:
The 21st Century Cures Act requires that any manufacturer or distributor of an investigational compound being studied for the diagnosis, monitoring or treatment of a serious disease must publish a policy regarding how individuals may request such investigational compound for expanded access treatment (often referred to as compassionate use). The policy must be published by the first initiation of a Phase II or Phase III clinical trial of the compound. If a company is already performing its Phase II or Phase III clinical trials, then the policy must be published within 60 calendar days after enactment of the 21st Century Cures Act: i.e., by February 8, 2017.
If you have any questions about whether your company must publish an expanded access policy, or the deadline for doing so, please contact us. Our life sciences team is well-versed with R&D activities, including compassionate use/expanded access treatment. Whether you need additional information about expanded access treatments, the requirements under the Act, an Expanded Access Policy customized for your company or a full suite of templates associated with expanded access requests, we are happy to help.
Please note that this Client Alert is not intended to be a comprehensive analysis of all provisions or compliance requirements under the 21st Century Cures Act. The Act is 996 pages and covers a broad range of individuals, companies, agencies and industries. Please contact us if you desire a more thorough analysis of the Act as it applies to your company.
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This Alert is provided for informational purposes only and is not intended to be, nor should it be construed as, legal advice on any specific matter, nor does it represent any undertaking to keep recipients advised of all relevant legal developments. This Alert does not create or constitute an invitation to create an attorney-client relationship, nor should it be construed as an advertisement or solicitation for legal services. This material may be considered Attorney Advertising in some states. Prior results do not guarantee a similar outcome.
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