Even though the FDA has recently proposed a new program to provide earlier market access to high-risk medical devices, FDA Commissioner Margaret Hamburg nevertheless came under fire for the agency being to slow to approve medical devices at the annual conference of the Advanced Medical Technology Association (AdvaMed) in Chicago. The implication of her inquisitors was that FDA delays are driving the medical device business to Europe, where device approval standards are more lax. Other health industry research groups disagree, believing that the FDA is acting responsibly, while Europe may be reexamining its lower approval standards.
New Expedited Program
The new FDA program was announced on April 22, 2014, through the issuance of a draft guidance entitled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” The Expedited Access PMA or EAP program is designed to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology and are subject to premarket approval (PMA) applications. The program features earlier and more interactive engagement with FDA staff during device development and more interactive review of investigational device exemption (IDE) applications. The FDA also intends to work interactively with the sponsor to create a data development plan specific to the device.
In addition to the EAP program, the FDA published a separate draft guidance outlining the agency’s policy on when data can be collected after product approval and what actions are available to the FDA if approval condidtions, such as postmarekt data collection, are not met. Entitled “Balancing Premarket and Postmarket Data collection for Devices Subject to Premarket Approval,” the draft guidance also includes advice on the use of surrogate or independent markers to support approval, cimilar to the data points used for accelterated prescription drug approval.
In response to reports that slow FDA approvals have sent medical device startups and clinical trials to Europe, Commissioner Hamburg responded (as reported in MedCityNews) that “It’s not a race to who’s first – it’s a race to get the best possible product to people.” Hamburg continued that “approval in Europe doesn’t mean it’s broadly available in the healthcare systems of those countries,” adding that Europe is “in a moment of examination of their regulatory system for devices” due to the emergence of some safety issues.
One example of this “moment of examination” may involve the European Union recall of tens of thousands of defective breast implants. According to an article in Reproductive Health Matters (RHM), “In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP [Poly Implant Prothese] breast implants that were recalled across Europe had been removed from the market years earlier in the U.S., a decision U.S. government health agencies can point to with pride.”
In an interview with Wolters Kluwer, Diana Zuckerman, PhD, President of the National Center for Health Research, and co-author of the RHM article, indicated she supported Commissioner Hamburg’s position on this issue. According to Zuckerman, recent studies show that devices get on the market in the U.S. about as fast as they do in other countries. In addition, “It is much easier to get insurance coverage for devices in the U.S. In most other countries, the national health plans won’t pay for devices unless they are proven safe and effective and sometimes need to be proven cost-effective. In the U.S., such requirements have been rare. It is very easy to get devices on the market in Europe and other countries, but difficult to get coverage until studies prove the device’s value. For that reason, and because devices cost so much more in the U.S. than other countries, device companies are always going to want to sell their products in the U.S. Whether their headquarters are in the U.S. or not, they need FDA approval to sell in the U.S. So, that is not going to influence whether a U.S. company moves to another country.”
From a follow-up discussion at the AdvaMed conference, The Boston Globe quotes Mark Deem, managing partner of the medical device startup The Foundry LLC, as stating that “the horse has already left the barn. It’s gotten to the point where entrepreneurs are just moving all their early stage medical device activities lock, stock, and barrel overseas.” With regard to the FDA’s EAP program, MedCityNews further opines that “Deem worries that it has taken so long for the FDA to realize it’s been shellacked by Europeans that it could be too little, too late.” Zuckerman, however, disagrees. According to Zuckerman, “the decision of some device companies to leave the U.S. is clearly related to the tax advantages of doing so, not related to the FDA approval process or standards for clinical trials in the U.S.”
Opposition to the EAP Program
Lest anyone think that the FDA’s new EAP program has full support, on July 22, 2014, members of the Patient, Consumer, and Public Health Coalition sent comments to the FDA indicating their lack of support for the program. While the coalition members sympathize with patients who suffer from life threatening or irreversibly debilitating disease, they believe that “the standards for PMA are already substantially lower than for prescription drugs…and yet, the [EAP program] lowers the bar for certain PMA medical devices even further.” The coalition believes “there is no guarantee that the [program] benefits would outweigh the risks for patients.” While the members indicate their support the program’s emphasis on earlier interactive communication between sponsors and the FDA, they also believe the program “gives undue emphasis on postmarket studies that are poorly monitored, have high loss to follow-up, and are rarely conducted in a timely manner that provides useful results.”