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.


Related Resources

August 17, 2017 - FDA Makes Moves to Advance Digital Health

May 4, 2017 -  EVENT: FDLI Annual Conference: Digital Health – What Does the Trump Administration, Cures Bills and Other Developments Mean for Digital Health

May 2, 2017 - Ted Mannen Quoted in “Implications of HHS’s 2017 Budget”

May 2, 2017 - Bradley Merrill Thompson Quoted in “New Clinical Decision Support Software Guidelines Highlight Keys to Self-Regulation”

April 28, 2017 - Bradley Merrill Thompson Quoted in “Legislation Would Streamline Risk-Classification for Device Accessories”

April 27, 2017 - Bradley Merrill Thompson Quoted in “Congress Chugging Along”

April 27, 2017 - Bradley Merrill Thompson Quoted in “Bipartisan House Bill Would Ease Device-Accessory Reviews”

April 24, 2017 - Bradley Merrill Thompson Quoted in “CDS Tools Fall Short in Meeting Physicians’ Needs in Care Delivery”

April 17, 2017 - Bradley Merrill Thompson Quoted in “Survey: Uncertainty About ACA Future Prevalent in Healthcare Industry”

April 14, 2017 - FDA Reauthorization Act of 2017

April 13, 2017 - Trump, Gottlieb, and the Cures Act: What Pharmaceutical Manufacturers Need to Know

March 24, 2017 - EVENT: ACI FDA Bootcamp: Ripped from the Headlines – Breaking News, Hot Cases, and Emerging Post-Election Trends that are Likely to Impact the FDA Practice

March 21, 2017 - James Boiani Quoted in “Combo Products Won’t Get Special Review Pathway at US FDA Anytime Soon”

March 20, 2017 - Bradley Merrill Thompson Quoted in “FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices”

February 2, 2017 -  FDA Adopts New Designation Process for Regenerative Advanced Therapies

January 31, 2017 -  Bradley Merrill Thompson Quoted in “Health IT Fallout from Latest Trump Order”

January 31, 2017 -  Bradley Merrill Thompson Quoted in “Hiring Freeze May Hurt FDA User Fee Programs, Democrats Say”

January 30, 2017 -  Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs

January 30, 2017 -  James Boiani, Bradley Merrill Thompson Quoted in “Trump’s Two-for-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say”

January 20, 2017 -  Memorandum for the Heads of Executive Departments and Agencies

January 20, 2017 -  FDA Says Yes to Pre-Approval Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications

January 20, 2017 -  Stuart Gerson Quoted in “Obama’s FDA Leaves Mark with Last-Minute Policy Blitz”

January 17, 2017 -  John Linehan Quoted in “Path of Uncertainty: Pharm Exec’s 2017 Industry Forecast”

January 12, 2017 -  A Record FCPA Year for Pharma

January 9, 2017 -  New Federal and State Initiatives Seek to Combat Antimicrobial Resistance

January 4, 2017 -  Bradley Merrill Thompson Quoted in “Potential Cures Hiccup Spotted”

January 2, 2017 -  James Boiani Quoted in “Life Sciences Legislation and Regulation to Watch in 2017”

January 2017 -  United States Congressional Committee Meeting Hearings

December 29, 2016 -  Bradley Merrill Thompson Quoted in “CDRH’s Guidance Goals for 2017”

December 15, 2016 -  Bradley Merrill Thompson Quoted in “Cures Act Adds Tough Penalties for Electronic Information Blocking”

December 15, 2016 -  Bradley Merrill Thompson Quoted in “Cures Exempts Some Medical Software; More Clarity Needed, Attorneys Say”

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 7, 2016 -  Bradley Merrill Thompson Quoted in “Congress Sends Cures Legislation to President”

December 5, 2016 -  Bradley Merrill Thompson Quoted in “21st Century Cures Act Clarifies FDA Regulation of Software”

December 2016 -  Mark Lutes Quoted in “What Will the Next Congress Do?”

November 30, 2016 -  Bradley Merrill Thompson Quoted in “‘Cures’ Bill Circumvents FDA on Medical Software Regs”

November 29, 2016 -  Bradley Merrill Thompson Quoted in “Cures Bill Could Lift FDA Regulation of Physician Software”

November 28, 2016 -  Bradley Merrill Thompson Quoted in “As Cures Bill Heads Towards Vote, Here’s What It Could Mean for Digital Health”