21st Century Cures
President Donald J. Trump has indicated that he wants to speed up drug approvals, cut through the red tape at the U.S. Food and Drug Administration (“FDA”), and reduce government regulations. He is in favor of expanding approval of drugs and medical technologies.
Prior to President Trump’s Inauguration, President Obama signed into law the 21st Century Cures Act (“Act”) on December 13, 2016. The Act is a sweeping biomedical research funding bill that had strong bipartisan support. Among its key provisions, the Act provides $4.8 billion over 10 years for the National Institutes of Health to fund key programs, such as President Obama’s Precision Medicine Initiative, Vice President Joe Biden's “Cancer Moonshot,” the BRAIN initiative, and regenerative medicine. The Act also earmarks $500 million to the Food and Drug Administration and streamlines the way that the agency approves drugs and medical devices. In addition, the Act provides $1 billion over two years for opioid prevention and treatment programs and makes certain reforms to federally regulated clinical investigations and Medicare Part A and Part B.
Once confirmed, President Trump’s appointees to fill the Secretary of Health and Human Services and FDA commissioner positions will have the responsibility to implement the Act. How they fulfill that responsibility, and the effect that their approach will have on payers, providers, and patient populations, will be carefully monitored by Epstein Becker Green.
August 17, 2017 - FDA Makes Moves to Advance Digital Health
May 2, 2017 - Ted Mannen Quoted in “Implications of HHS’s 2017 Budget”
April 27, 2017 - Bradley Merrill Thompson Quoted in “Congress Chugging Along”
April 14, 2017 - FDA Reauthorization Act of 2017
February 2, 2017 - FDA Adopts New Designation Process for Regenerative Advanced Therapies
January 20, 2017 - Memorandum for the Heads of Executive Departments and Agencies
January 12, 2017 - A Record FCPA Year for Pharma
January 4, 2017 - Bradley Merrill Thompson Quoted in “Potential Cures Hiccup Spotted”
January 2017 - United States Congressional Committee Meeting Hearings
December 29, 2016 - Bradley Merrill Thompson Quoted in “CDRH’s Guidance Goals for 2017”
December 14, 2016 - The Future Impact of Populism on Drug Pricing Reform
December 8, 2016 - Politics, Populism, and the Future of Prescription Drug Pricing Reform
December 2016 - Mark Lutes Quoted in “What Will the Next Congress Do?”