EVP, Chief Creative Officer at Grey Healthcare Group
If the pace of innovation in drug development has slowed in the past decade, pharma may have itself to blame; after all, the number of new drug applications has declined, and the FDA can only approve 'em as fast as someone else discovers 'em. But who's to blame for the slowdown in availability in the US of the innovations in medical devices worldwide? Here, there may be room to question whether regulatory is innovating as fast as the industry it oversees.
After several very public device failures (from hearts to hips) that left the FDA open to criticism of leniency, the pendulum seems to have swung the other way. In an attempt to improve device regulation, manufacturers are faced with new hurdles, uncertain pathways, and steep clinical investments to bring innovations to market—significant enough to drive many away from the US market.
Medical devices and their cousins, mobile health apps, are a booming source of innovation and industry in this country, led by technology advances that are redefining the healthcare landscape. But how can we balance incentives for innovation against protecting patient safety in this coming age of e-medicine?
The FDA has acknowledged the manpower issues, and industry has agreed to pony up twice the fees in coming years to fund additional resources. But we need more than extra eyes. A new way of looking at regulation of devices, and other real healthcare innovations like personalized medicine, may be the real cure for what ails us. Public safety will benefit from higher levels of post-marketing surveillance, as pending congressional legislation allows. But how high should the burden of efficacy and safety be set in a field where innovation cycles are measured in months, while clinical trials can take years?
One consideration that would encourage innovation would be to create exceptions not only for rare diseases, but also rare instances of overwhelming efficacy. Recognizing significant advances early, and giving them different regulatory treatment, might incentivize fewer “me-too” brands and reward truly breakthrough discoveries with faster, well-monitored access.
Innovation demands risk. We need a system of approval with built-in, transparent risk/benefit assessments, allowing physicians and patients to knowingly assume some of that risk as the price for innovative care. When it comes to medical advances, it's not just a matter of balancing safety and efficacy—it's a matter of balancing acceptable risk and transformative innovation.