One of the only major bipartisan moments in recent Congressional history is the physician-backed repeal of the Sustainable Growth Rate (SGR) earlier this year. Some held hope 21st Century Cures would follow in the same fashion. However, recent developments indicate the legislation may be suffering a slow demise despite clearing the House with an overwhelming majority of votes.
Background
In April 2014, Energy and Commerce Committee Chairman Fred Upton (R-MI) partnered with Rep. Diana DeGette (D-CO) to launch the 21st Century Cures initiative with an important goal: to accelerate the discovery, development, and delivery of new treatments and cures for patients. Over the course of nearly a year, patients, providers, innovators, regulators, and researchers from around the country provided a wide range of specific ideas on how Congress could help. Although the bill appeared to have bipartisan backing, there was still a minority contingent, especially in the Democratic Party, that expressed concerns.
In April, we were happy to report the bill’s language contained positive news for the CME industry, a welcomed development from a previous version of the legislation. Specifically:
Subtitle C—Encouraging Continuing Medical Education for Physicians: Exempting from manufacturer transparency reporting certain transfers used for educational purposes.
Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]
(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:
(iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
(xiii) In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient
(I) for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; or
(II) that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.
Rep. Fred Upton (R-MI), the chair of the Energy and Commerce Committee, and Rep. Diana DeGette (D-CO), one of the panel’s senior Democrats, further stated their case for the legislation in a published editorial stressing the need to bring together stakeholders from FDA, NIH, private industry, academic, patients, and other areas to generate better health outcomes. “From facilitating basic research to streamlining the drug and device development process to unleashing the power of digital medicine and social media at the treatment delivery phase – this cycle is what saves lives. There should be no gap between 21st century science and the Washington regulatory process. No opportunities to foster the cycle of discovery, development, and delivery should go unexplored,” they wrote.
House Votes
In June, two hundred and thirty bipartisan members of Congress added their names as co-sponsors of H.R. 6, the 21st Century Cures Act. And previously, on May 21, 2015, the House Energy and Commerce Committee unanimously approved the bill. The version voted upon was a 300 page bill with dozens of provisions, including funding to both the FDA and the NIH, efforts to streamline clinical trials and accelerate the approval of safe and effective treatments, promoting the patient perspective into medical developments, and the advancement of personalized, or precision medicine. Precision medicine allows doctors to use a patient’s DNA to fight diseases, by customizing gene therapy to each individual patient. The bill also seeks to modernize the regulations surrounding communication from manufacturers to healthcare providers and payers. The legislation further received letters of support from hundreds of organizations, including patient groups, the Association of American Medical Colleges, sixty-seven cancer institutes, and seventy-five research, life sciences, and patient advocacy organizations.
On July 10, the U.S. House of Representatives approved the 21st Century Cures Act by a vote of 344-77. The bill received overwhelming bipartisan support, despite some opposition from conservatives to the mandatory spending stream to NIH. “The legislation will help to bring our health care system into the 21st Century, investing in science and medical innovation, incorporating the patient perspective, and modernizing clinical trials, to deliver better, faster cures to more patients and loved ones in need,” the Energy and Commerce Committee stated. We offered analysis of the legislation in our Life Science Compliance Update.
John Kamp, Executive Director at the Coalition for Healthcare Communication described the vote as an “unusual bipartisan effort to save lives and increase the quality of lives of millions of American citizens by speeding the drug and device approval processes and enabling more robust information sharing by industry.”
Andrew Rosenberg, Senior Advisor to the CME Coalition was equally positive about the passage of the bill: “With passage of this bill, the House of Representatives has acknowledged that commercially supported CME plays an important role in educating our doctors and improving patient access to innovative therapies. We next look forward to the Senate taking up similar legislation to encourage the practice of continuing medical education.”
The Senate, however, is where the legislation finds itself stuck today.
The Senate
A recent report described the bill as “on life support”. Success, to this point, has been attributed solely to Rep. Upton himself, who is in the final session of his chairmanship. The article speculates the bill may have had strong support merely because of Upton’s name on the legislation. Funding issues remain, made worse by recent developments. The legislation’s biggest pay-for, revenue from the Strategic Petroleum Reserve, may not be available. The money was included in a Senate version of highway legislation, although the issue remains unsettled between the House and Senate.
However, it was reported that the Senate HELP committee will take up its own medical innovation bill this fall. Additionally, Senate Democratic Whip Dick Durbin has an alternative medical innovation bill that is “substantially different” than the 21st Century Cures bill, including on the amount of funding it gives the NIH–$26.6 billion over the next five years instead of $8.75 billion in the 21st Century Cures bill. Ultimately, the Senate hopes to get the HELP committee’s version of the bill done before the end of the year and it is guaranteed to be different from the House version, requiring a conference over the two different versions.
In some ways, this could work in favor of the 21st Century Cures bill. If it is pushed back to the fiscal year 2017, there may be an ability to classify spending as discretionary which reduces the pressure to find pay-fors and criticism from budget hawks, along with spending cap increases. It also still has the support of President Obama.
Additionally, on September 15, Senators Michael Bennet (D-CO), Richard Burr (R-NC), Elizabeth Warren (D-MA), and Orrin Hatch (R-UT) introduced the Advancing Targeted Therapies for Rare Diseases Act of 2015, promoting the development of targeted drugs for patients with serious or life-threatening rare genetic diseases. This comes on the heels of other related legislation, and may ultimately be part of the Senate’s counterpart to the House-passed 21st Century Cures bill.
FDA Funding
Current acting FDA commissioner Stephen Ostroff, MD (perhaps soon to be former acting) said the agency was “very comfortable with the content” in the bill. However, FDA’s concern “continues to be the costs associated with doing the things we’re being asked to do in that bill. We were certainly happy with the fact that there were funds dedicated for FDA; our estimation is that the funds available are not necessarily going to cover everything we’re expected to do. If that [version passes the Senate], then those resources have to come from somewhere.”
The Senate is still working on its version of the bill, which is expected out next month, Ostroff said. The likely next FDA commissioner, Robert Califf, would find 21st Century Cures as one of several vehicles through which FDA will face broad new responsibilities and major changes. Adequate and consistent FDA funds will be important for the agency to carry out the work that would be required by new legislation.
Conclusion
We will continue to monitor the 21st Century Cures legislation and any potential bill from the Senate. We hope legislation that makes it through the Senate contains similar CME language as the House version. That is yet to be seen. It could take many months for there to be clarity, unfortunately, as Rep. Upton and Rep. DeGette’s multi-year project may need to find its own cure for the negative momentum currently plaguing the legislation in the Senate.