The nation is at a turning point in modern health care. To usher in this new age of digitally-driven, personalized care, federal agencies must be equipped to keep the United States at the forefront of medical innovation.
One area in which the United States still has significant work to do is in finding the next generation of cures; for the 10,000 known diseases, there are only 500 treatments. How can this be changed? That is what we seek to answer in this report. Through extensive research and interviews with industry, patient groups, academia, government, and legislators, BPC has developed viable policy actions that Congress can take to reduce both the time and cost of developing and delivering safe and effective medical products to patients.
BPC’s report focuses specifically on how to modernize the development of drugs and devices. This includes the activities of the Food and Drug Administration (FDA)—the regulatory agency that oversees the safety and effectiveness of medical products sold in the United States. One out of every $4 spent by consumers each year is on an FDA-approved product, including drugs, devices, food, and tobacco. Expensive development and lengthy approval processes can slow access to new technologies; a new drug on average takes nearly $2 billion and a decade to make it to market. With increased consumer cost-sharing, expensive drugs and devices are already becoming out of reach for many Americans. And for those facing a disease with potential life-saving treatments in trials, the clock is ticking entirely too slowly.
BPC’s recommendations focus on improving the medical product development process, improving regulatory clarity, strengthening the FDA’s ability to carry out its mission, and increasing investment in medical products to address unmet and public health needs—all of which are expected to improve our nation’s competitiveness in the global marketplace.
Americans cannot afford to rely on 20th century methodologies when the world is on the cutting edge of new health technologies. The hardworking FDA employees must be given the tools and support they need to succeed in this rapidly evolving field. It’s time to take action to significantly advance medical innovation in the United States.
KEYWORDS: FOOD AND DRUG ADMINISTRATION