|Expedited Access Pathway: for patients
who have few or no other options.
Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.
Two accelerated manufacturing programs currently in the spotlight are the 21st Century Cures Act
and its medical device sibling, the Expedited Access Pathway
(EAP) program. Dissenters believe these programs might compel FDA to relax its regulatory oversight
in order to fast-track a product’s development and manufacturing. According to Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren, it’s quite the opposite. In an FDA Voice blog post
, Shuren summed up EAP as a way to “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.”
FDA is committed to EAP as a way of getting critical medical devices to market faster. With EAP, FDA staff is more actively involved with the development and testing processes, but still expects eligible companies to do the heavy lifting. This works in conjunction with FDA’s process for determining both the risks and benefits of a new device as well as the risks of delaying getting the device to patients who have few or no other options.
For prospective EAP device manufacturers, the bar is still high for gaining FDA approval. Companies hoping for EAP designation need to provide all the necessary documents and meet the regulatory standards a lot faster. This leaves little time for responding to requests for additional information and little room for error. According to acting clinical trials director at FDA, Owen Faris, Ph.D, “because of the resource intensiveness of this program, we really do want to see companies coming to us as prepared as possible, so that we’re not starting at absolute ground zero.” (MDDI July 2015
A pared down version of the program’s eligibility includes these three criteria:
- The device is designed to treat or diagnose life-threatening or irreversibly debilitating disease or conditions.
- Sponsor must submit an acceptable draft Data Development Plan.
- The device addresses an unmet medical need—a condition whose treatment or diagnosis is not addressed adequately by an available therapy or diagnostic.
Being prepared means device manufacturers need to give FDA as much of a glimpse into the unknown as possible. Having met the first two criteria, sponsors are strongly encouraged to get FDA involved early by submitting a Data Development Plan, which is a thorough description of all premarket and postmarket studies and data the sponsor company will gather and report on. FDA recommends that companies incorporate a discussion of the relevant benefit-risk information in the Data Development Plan as part of their EAP justification.
Under the EAP program, FDA intends to provide more interactive communications during device development. Sponsors can improve their EAP candidacy by taking advantage of FDA consultation, which includes building out a roadmap for the device development, marketing and postmarket data review. Even at this point, EAP approval is still not guaranteed.
Information accuracy and turnaround time is critical for sponsors. When seeking EAP designation, the onus of providing complete and accurate information is on the sponsor. FDA intends to review presubmission information within 30 days of receipt. If the presubmssion information is not sufficient to make a determination, FDA may request additional information. If FDA has not received enough information within 30 days after a request for additional information, it will reject the EAP request. (EAP Guidance for Industry and Food and Drug Administration Staff)
With the EAP program, there is a level of uncertainty that FDA is willing to accept because it feels that much of the data can be obtained and reviewed during manufacturing and after a product is on the market. Still, sponsors need to demonstrate an ability to provide all the required information when requested and keep pace with the required timelines. This is where sponsors can benefit from electronic document management (EDMS) software to help keep their own documentation current, error-free and readily available.
Tracking down the necessary documents with a paper-based document management system is challenging enough without the pressure of a stringent turnaround time. In the event that several versions of a document are circulating, there is a high risk that the retrieved information is obsolete, uncontrolled or incomplete.
When patients are waiting for breakthrough technology, the ability to automate document routing, approval and version control is essential for developing products under the EAP program. With an EDMS, documents will not get lost and it’s much easier to retrieve the correct documents because an automated system tracks every document’s location, version, approval status and archival.
In what ways do you think the EAP program will change medical device manufacturing? Please share your thoughts below.
David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.