User fees: Ensuring a stronger and better FDA
By: Margaret Hamburg, M.D.
FDA receives thousands of applications for potentially promising medical products every year. Reviewing these often scientifically-complex submissions is the responsibility of a large team of doctors, chemists, bioengineers, statisticians and other experts who must determine whether a proposed new product is safe and effective for patients, and do so within a certain time period.
It takes steady and reliable funding to maintain and support a staff of trained reviewers capable of accomplishing this vital task. We're gratified that Congress agrees, as demonstrated by today's passage of the Food and Drug Administration Safety and Innovation Act in the US Senate by a vote of 92-4. Since the House of Representatives passed the bill last week by a voice vote, the bill now heads to the President's desk, where it is expected to be signed into law. This legislation, when enacted, will authorize the FDA to collect user fees from industry to fund the review of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Such overwhelming support for FDA user fees is a testament to the important role FDA plays in America's healthcare continuum. FDA's medical product decisions sit at the intersection of public health, innovation, and commerce and touch the lives of nearly every American every day.
Today's positive vote also reflects the success of FDA's commitment to transparency and collaboration in developing user fee proposals that all sides could support. FDA negotiators spent months in discussions with industry and consulted closely with patients, consumers and health care providers before arriving at proposals for each of the four programs.
Driving these discussions is the recognition that user fees have been a big success, reversing what was once a lag in the time needed for drug approvals. Since the prescription drug user fee legislation (PDUFA) was enacted in 1992, time to market for priority drugs has decreased from an average of 2 years to 1.1 years recently. This has provided patients faster access to over 1,500 new drugs and biologics, including treatments for cancer, infectious diseases, neurological and psychiatric disorders and cardiovascular diseases.