Only 51% of US companies are compliant with Expanded Access visibility laws
Analysis of compliance from Clinical Trials Arena, 3/22/23
According to a recent analysis by Clinical Trials Arena, many US-based drug companies do not comply with legal expanded access visibility requirements. The 21st Century Cures Act requires companies to make their expanded access policy for evaluating and responding to requests “public and readily available.” (The law does not require companies to offer expanded access, but they must make their position publicly visible.) However, only 51% of qualified US drug companies appear to fully comply with these expanded access visibility requirements, and an additional 10% of companies appear to partially comply.
Overall, the study suggests that the Cures Act may be having a limited impact on its goals of supporting timely medical decisions and closing informational gaps for patients and doctors around expanded access to investigational oncology therapies.
What is causing the lack of compliance?
While the lack of visibility hinders awareness, many smaller companies may feel they lack the resources to run an expanded access pathway. Companies that fully or partially comply with these requirements had, on average, more employees and higher revenues than companies that did not comply. The analysis shows that there is a lack of awareness that has hindered the pathway’s use, and while many patients have heard of clinical trials, far fewer are aware of expanded access pathways and procedures. The lack of compliance is concerning as the goal of the FDA’s expanded access pathway is to offer access to experimental drugs for patients with ultra-rare or life-threatening diseases who would not otherwise have access to clinical trials.
Compliance has risen since 2021
The good news is that the number of companies complying with regulations appears to have actually risen in the past two years. A study published in December 2021 in Clinical Pharmacology & Therapeutics analyzed the implementation of the Cures Act's expanded access policy requirements among US biopharmaceutical companies with an oncology-related drug. The study found that only about one-third of the applicable companies (32%, or 140 out of 423) had implemented the Cures Act's requirement to have a public expanded access policy. In that study, less than one-third of the public policies contained all the information required by the Act.
The study also found that larger companies and those with at least one drug receiving an FDA expedited designation or at least one FDA-approved drug were more likely to have a public policy. This suggests that smaller and newer companies may be facing challenges in implementing the Cures Act requirements.
What’s required to comply?
Companies developing investigational therapies must publish their expanded access policy. All policies, even if Expanded Access is not offered, must include:
Contact information and request process
Criteria for evaluating requests
Expected time to acknowledge receipt
Even if the company is not offering Expanded Access, proactively explaining why the company may not be able to accommodate requests provides transparency and responsiveness to patient inquiries. You can learn more about how MedaSystems can quickly and easily help your company comply with the requirements and ensure that you are meeting the needs of patients and physicians who might be interested in your therapy.