The lame duck session in Congress has seen very little legislative activity save for the 21st Century Cures Act (H.R. 6), which has passed both the House and Senate in a rare bipartisan accomplishment.
Marked as a priority for the Republican leadership seeking to pass the bill during the remaining weeks of the post-election session, a compromise version was released over the Thanksgiving holiday weekend. Through its three-year journey of hearings, debates, and lobbying from multiple stakeholders, the latest version was voted on and passed out of the House on November 30 by a vote of 392 to 26 and a Senate vote of 94 to 5 came in a week later on December 7. President Obama has praised these efforts and said he would sign it.
Introduced to Congress and championed by Rep. Fred Upton (R-MI), the bill has been lauded as the “Innovation Bill” because of its $4.8 billion designated for three signature Obama administration research programs over the next 10 years: Vice President Joe Biden’s “Cancer Moonshot,” the BRAIN Initiative, and the Precision Medicine Initiative. In addition, H.R. 6 also gives states $1 billion to fight the nation’s opioid crisis. Disappointing to some Democrats, however, is that only $500 million will go to the Food and Drug Administration. A provision of the bill will require that the flow of money be reauthorized each year.
At 996 pages, the bill generated very heavy lobbying efforts from multiple stakeholders — from trade groups to academia, hospitals, medical schools, and medical associations. Some continue to strongly express concerns over the easing of FDA approval standards for new drugs and medical devices, while others applaud it and see the FDA changes as an opportunity to create an accelerated approval pathway.
The Cures Act also eases a provision in the Affordable Care Act called the Physician Payment Sunshine Act. The Sunshine Act requires drug and device companies o publicly report virtually all payments to physicians, including meals, gifts, travel, and royalties, as well as speaking and consulting fees. As dozens of medical societies called for exemptions, under the Cures Act, companies will not have to report the value of textbooks and medical journal reprints given to doctors, nor will doctors need to disclose payments for continuing medical education courses.
President Obama will have up until his last day in office to sign the 21st Century Cures Act into law.