Washington, DC — President Donald J. Trump on August 18 signed into law a funding package for the Food and Drug Administration (FDA) that also takes steps to lower drug prices.
The FDA Reauthorization Act (FDARA) of 2017 reauthorizes a program in which drug and medical device makers pay the FDA a fee for every new product application. The agency uses those funds to hire more people and speed up approvals.
The user fee program must be reauthorized every five years. The current program expires at the end of September, and if it hadn't been signed into law before then, the agency would have had to lay off workers.
The FDA Reauthorization Act (FDARA) of 2017 reauthorizes a program in which drug and medical device makers pay the FDA a fee for every new product application. The agency uses those funds to hire more people and speed up approvals.
The user fee program must be reauthorized every five years. The current program expires at the end of September, and if it hadn't been signed into law before then, the agency would have had to lay off workers.
The law also includes a measure that lets the FDA hasten development of a generic drug if an off-patent product with no competition is being sold at an egregiously high price.
Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl issued the following statement following the President’s signing the bill:
“PhRMA commends President Trump for signing into law the FDA Reauthorization Act of 2017 (FDARA), which includes the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), as well as the biosimilar and generic drug user fee amendments.
“In today’s new era of medicine, where breakthrough science is transforming patient care, today’s signing of FDARA is a major victory for the patients in need of innovative, lifesaving treatments.
“By reauthorizing PDUFA and the other user fees, the administration is leading the way toward greater efficiency at the U.S. Food and Drug Administration (FDA) and increasing competition in the biopharmaceutical market.
“We further appreciate the leadership that Health and Human Services Secretary Tom Price and FDA Commissioner Scott Gottlieb demonstrated throughout this reauthorization process.”
Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood also released a statement the same day:
“President Trump’s signature today on this landmark legislation is the culmination of a years-long collaborative process in which patients, industry, FDA, legislators and other stakeholders worked tirelessly to identify ways in which FDA’s human drug review programs can be improved to deliver better health care for every American and enhance the incorporation of the patient voice in drug development and review.
“BIO is proud to have played a part in these efforts and prouder still of the important advances for patients and medical innovation that this law will help achieve. Whether it be bringing patients’ perspectives more closely to bear in regulatory decision-making, speeding new medicines to market by making the clinical trial process more efficient, or increasing competition from generics and biosimilars, the provisions of this law will make our healthcare system more responsive to the needs of patients.
“We look forward to working with Commissioner Gottlieb to ensure that these critical advancements are most effectively implemented. We thank the leaders from both parties and in both chambers of Congress for their tireless bipartisan efforts in crafting this historic achievement.”
Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl issued the following statement following the President’s signing the bill:
“PhRMA commends President Trump for signing into law the FDA Reauthorization Act of 2017 (FDARA), which includes the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), as well as the biosimilar and generic drug user fee amendments.
“In today’s new era of medicine, where breakthrough science is transforming patient care, today’s signing of FDARA is a major victory for the patients in need of innovative, lifesaving treatments.
“By reauthorizing PDUFA and the other user fees, the administration is leading the way toward greater efficiency at the U.S. Food and Drug Administration (FDA) and increasing competition in the biopharmaceutical market.
“We further appreciate the leadership that Health and Human Services Secretary Tom Price and FDA Commissioner Scott Gottlieb demonstrated throughout this reauthorization process.”
Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood also released a statement the same day:
“President Trump’s signature today on this landmark legislation is the culmination of a years-long collaborative process in which patients, industry, FDA, legislators and other stakeholders worked tirelessly to identify ways in which FDA’s human drug review programs can be improved to deliver better health care for every American and enhance the incorporation of the patient voice in drug development and review.
“BIO is proud to have played a part in these efforts and prouder still of the important advances for patients and medical innovation that this law will help achieve. Whether it be bringing patients’ perspectives more closely to bear in regulatory decision-making, speeding new medicines to market by making the clinical trial process more efficient, or increasing competition from generics and biosimilars, the provisions of this law will make our healthcare system more responsive to the needs of patients.
“We look forward to working with Commissioner Gottlieb to ensure that these critical advancements are most effectively implemented. We thank the leaders from both parties and in both chambers of Congress for their tireless bipartisan efforts in crafting this historic achievement.”
