Life Science Compliance Update

May 21, 2015

21st Century Cures Act Passes 51-0 in House Energy and Commerce Committee

21ST CENTURY

This morning, the House Energy and Commerce Committee voted 51-0 to approve the 21st Century Cures Act. With the way the bipartisan bill sailed through, it appears the 21st Century Cures train has left the station.

The Act was authored by full committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member DeGette, 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). 

"This historic day marks a big bipartisan step forward on our path to cures,” said Upton. “We have all said too many early good-byes to people we love and treasure. Every single person has a common goal: we want more time with those we love. In this, the greatest country in the world, Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.” 

"In the last century, American medicine leapt from medicine shows to the mapping of the human genome,” said DeGette.”With the 21st Century Cures Act, we seek to support the biomedical community in making a similar leap forward in this next century. With billions in support for our premier research and development institutions and comprehensive reform of our systems, 21st Century Cures will make a real difference in the lives of patients and their families." 

Rep. Green added, “I’m proud of the final bill that was voted out of Committee, which will improve the innovation ecosystem for the development of life-saving medical breakthroughs, foster the development and the interoperability of health information technology, and better leverage critical resources to facilitate the discovery of new cures. After one year of deliberation, research, and stakeholder input we’re one step closer to delivering new cures and therapies, and hope to patients.”

After the voting, Congressman Joe Barton (R-TX) expressed his enthusiasm for the fact that the Cures bill was unanimous:

I’ve been on the Committee for 28 years, and I don’t think we’ve ever had a major bill that didn’t have somebody...that voted no. That is an amazing accomplishment Mr. Chairman, and I think the Committee should congratulate you, Mr. Pallone, Ms. DeGette, Mr. Pitts, and all the other members who worked in a leadership role.

This is a real achievement. This will change America. This will change the world for the better. This will last. This bill will become law and it will last for decades.

That is a real achievement.

 

The 21st Century Cures Act is full of important provisions, including a number of issues regularly covered on Policy and Medicine.

Encouraging Continuing Medical Education for Physicians

Section 3041 would exempt certain transfers of value to physicians from Sunshine reporting requirements that physicians have indicated hinder them from participation in important continuing medical education activities.

Section 2101:  Facilitating Dissemination of Health Care Economic Information

This section would add clarity and facilitate dissemination of health care economic information, as defined in the section, to payers, formulary committees, or other similar entities.

Section 2102:  Facilitating Responsible Communication of Scientific and Medical Developments

This section would require FDA to issue guidance on facilitating responsible, truthful, and nonmisleading scientific and medical information not included in the label of drugs.

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John Kamp, the Executive Director of the Coalition for Healthcare Communication, called 21st Century Cures "a great step forward for American patients." Andrew Rosenberg of the CME Coalition notes that Congress "has demonstrated the commitment to CME as a bipartisan issue." 

We will continue to provide updates to the 21st Century Cures Act progress as it moves through the House and Senate. 

April 29, 2015

“Encouraging Continuing Medical Education For Physicians” Incorporated Into Newly Updated 21st Century Cures Discussion Draft

Notable updates to January's Draft include bipartisan concessions: New provisions to increase NIH funding; removal of provisions for increased exclusivity periods. 

Ladd email

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. 

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