“The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions.”
That’s one of the final lines of Senate bill 3187, which passed the Senate 96 to 1 yesterday, and is expected to easily pass in the House. The bill is also known as the “Food and Drug Administration Safety and Innovation Act” or — more importantly — PDUFA V, the fifth installment of the early-1990s regulatory change that forever altered the Food and Drug Administration. It’s an important line, and this is an important piece of legislation. Here’s why:
PDUFA, the Prescription Drug User Fee Act, was first passed in 1992 and it set up the drug regulatory system we have today: companies pay “user fees” to the government, and the FDA works to review drugs in a timely fashion. The initial law had a revolutionary effect, ramping up approval times and changing the FDA from a plodding bureaucracy, often behind the rest of the world in approving new products, into a far more efficient regulatory machine.
PDUFA must be renewed every 5 years, and each iteration has brought subtle changes. The last two iterations focused on making the agency more safety-conscious, boosting the agency’s funding to spot unexpected adverse events. But this go-round, the focus has been on making the agency more patient-centric.
It’s not just that the FDA will start implementing “strategies to solicit the views of patients.” They’re changing the rules to bring drugs to populations with serious and life-threatening diseases, bringing a regulatory pathway already in place for cancer and HIV drugs to a much broader group of diseases.
While the specifics of the bill will no doubt change the way that industry interacts with industry, the explicit inclusion of patients should be of more general interest to those of us in health communications. It is yet another acknowledgment of the welcome trend of ensuring that patient voices are a part of the dialogue around public health.
Just as medical meetings and others are beginning to recognize the importance of the patient perspective, the FDA will also be amping up the attention they pay to this hugely important group. That means that communications firms and companies that ignore what patients are saying will be depriving themselves of counsel that will be informing the direction of modern medicine. And while building relationships between patients and industry is not without issues (many of which were discussed at the “Friending Pharma” SXSW panel), such issues must be addressed head-on to ensure open communication between every part of the health care system.
Because we know the FDA will be listening. We cannot afford to do any less.