Notable updates to January’s Draft include bipartisan concessions: New provisions to increase NIH funding; removal of provisions for increased exclusivity periods.
Today, the House Energy and Commerce Committee released an updated discussion draft of 21st Century Cures legislation (view the legislative text, whittled from 400 pages to 199 pages since January); a section-by-section explainer; and a 1-page summary). “The yearlong 21st Century Cures listening session explored the complete cycle of cures – from the discovery of clues in basic science, to the development of new treatments, to the delivery of those cures, and back again to further discovery,” the House notes in the press release for the new bill.
Unlike January’s release of the draft, which Democrats did not formally endorse, today’s document is issued as a bipartisan bill by Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Full Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).
Concessions: NIH Funding In; Market Exclusivity Out
One of the most notable new aspects of the bill—clearly evidenced as the lead off provision—is that the 21st Century Cures bill would raise NIH funding to $31.8 billion in 2016 and to $34.85 billion in 2018. The bill would also create an NIH Innovation Fund of $2 billion per year to support “precision medicine” and “young emerging scientists.”
Another important change is the absence of provisions which extended the marketing exclusivity. The January version of the bill included a 15-year marketing exclusivity for “dormant therapies,” defined as medicine that “is being investigated or is intended to be investigated for an indication to address one or more unmet medical needs…” The old bill also sought more exclusivity for “New Therapeutic Entities” and “Orphan Products.” View Title 1, Subtitles L, M, and N in the old bill’s language, not found in the new version.
Encouraging Continuing Medical Education for Physicians
Most interesting to Policy and Medicine readers likely concerns the status of the continuing medical education provision in the new bill. The language is updated considerably from the first go-round.
Subtitle C—Encouraging Continuing Medical Education for Physicians:Exempting from manufacturer transparency reporting certain transfers used for educational purposes.
Updates to the Sunshine Act reporting requirements are included in red.
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.
This language is much clearer than previously set forth. CME Coalition Senior Advisor, Andy Rosenberg, was encouraged by the language in the new bill, and commended the bipartisan effort set forth in the 21st Century Cures initiative.
Sharing Off-Label Data and Social Media
Also of note, the original draft’s provision encouraging FDA to consider a new regulatory approach to social media has been dropped from the final bill. This could be in recognition of the fact that FDA has agreed to align their guidances concerning scientific exchange with the First Amendment.
This new bill includes an important section entitled “Facilitating Dissemination of Health Care Economic Information,” which offers some regulatory leniency concerning communications with payors and formulary committees. This is especially significant given the more prominent decision-making role payors play in the current health care environment.
Other Highlights in the Bill
The Energy and Commerce Committee ran down a short list of provision highlights in the bill, which, in addition to increasing the flow of funds to NIH, also:
- Incorporate the patient perspective in the discovery, development, and delivery process.
- Foster development of treatments for patients facing serious or life-threatening diseases.
- Repurpose drugs for serious or life-threatening diseases and conditions.
- Modernize clinical trials.
- Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
- Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
- Provide for continued work in the telehealth space.
- Advance a truly interoperable health care system.
- Provide clarity for developers of software products used in health management and medical care.
We will continue to cover this important legislation as it makes its way through Congress.