Life Science Compliance Update

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July 09, 2014

“21st Century Cures” Initiative Seeks To Accelerate the Pace of Cures and Medical Breakthroughs; Highlights Importance of Technology and Collaboration

The 21st Century Cures initiative is a new bipartisan effort to bridge the gap between medical advances and the regulatory policies that govern them. The initiative started with a collaboration between Representative Fred Upton (R–MI), the chair of the Energy and Commerce Committee, and Representative Diana DeGette (D–CO), one of the panel's senior Democrats. The initiative aims to examine the "full arc" of the innovation process to get new treatments and cures to patients more quickly. The committee hopes to streamline the drug and device development process, and "unleash[] the power of digital medicine and social media" in the treatment delivery phase. 

In an article co-authored by Upton and Degette discussing their vision, the lawmakers stated: "There should be no gap between 21st century science and the Washington regulatory process." Groundbreaking medical breakthroughs have the potential to redefine patient care. For example, "granular-level biochemistry," Upton notes, has the potential "to take early detection to a whole new level, identifying and treating defective genetic structures even before they produce clinical symptoms." Furthermore, advances in technology and social media allow an amazing level of connectivity between patients, doctors, and scientists. 

"The revolution in molecular biology, computing power and social networks demands that we take a fresh look at our drug approval regime and make sure it is taking advantage of all these new tools," Upton argues. Health research is moving quickly, "but the federal drug and device approval apparatus is in many ways the relic of another era." Degette states, "when our laws don't keep pace with innovation, we all lose."

Recent Activity

In the time since the initiative was announced April 30th, the Committee has released several whitepapers and hosted roundtable discussions and hearings focused on how best to accelerate the pace of cures in America.

Most recently, the Committee released a digital health white paper and on June 24th, held a roundtable discussion about leveraging technology to accelerate the discovery, development, and delivery cycle of new cures. Upton and his committee believe technology holds great potential to help healthcare evolve. "As we work toward a path to cures," Upton states, "we must always be improving and evolving, embracing the technologies of today as we pursue the treatments for tomorrow."

The roundtable included industry experts, doctors, and CEOs, who discussed the commercial and regulatory barriers that prevent healthcare technologies from being used on a larger scale in the treatment process.

"First and foremost," Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA states is the importance of "accurate information." When technology analyzes patient information on a large scale, in order to be beneficial to patients, the information must be correct.

Another major obstacle is the "lack of interoperability and sharing of health information," notes Joseph M. Smith, M.D., chief medical and science officer at West Health. Current business models keep everything separate. Smith wants a "seamless flow of information at the point of care."

The idea is that communities of people online, along with companies with molecular and genetic databases, can help target, contact, and monitor people much more efficiently than the current clinical trial process. Dr. Brian Druker, director of the Oregon Health and Science University's Knight Cancer Center, states that he envisions in the not too distant future a cancer patient who is able to benefit from a "million cancer patients before them" through the use of technology.

In addition to utilizing "big data," a major them of the roundtable was patient involvement in their own healthcare. Technology can help. Fierce HealthIT noted that panelists "touted the importance of consumer control over their own healthcare information." Anne Wojcicki, co-founder of DNA-analysis company 23andMe stated: "For the first time, technology and healthcare are coming together and consumers want to be part of it." Interestingly, late last year, 23andMe received a Warning Letter from FDA, ordering it to stop marketing its saliva kits for personal genome testing.

Upton took issue to this in an article earlier this year: "Again, today's FDA seems less than open to these new tools. Instead of welcoming innovators like 23andMe – a company that seeks to empower individuals by supplying them with individualized health information – the FDA has shut down one of the company's key offerings."

Mark Blatt, the Worldwide Medical Director of Intel Corporation, spoke about the OpenNotes program, adopted by some healthcare facilities, including the Cleveland Clinic. Blatt used the program as an example of how patients can have access to their healthcare information. OpenNotes gives patients access to the visit notes written by their doctors. It's a free technology that encourages patients to directly get involved in their healthcare, Blatt said.

The Committee also discussed how patient privacy may be affected by data analysis and how to address privacy concerns and informed consent to data collection.  The committee said it wants to create a regulatory framework that not only keeps privacy at the forefront, but also allows development and innovation when it comes to treatments and cures for patients. A number of speakers noted that HIPAA may be "protecting patients to death." Martin Harris, CIO of the Cleveland Clinic, spoke about HIPAA compliance, saying there should be general regulation of the program that empowers a patient to opt out.

Economic and Regulatory Incentives for Cures

Earlier this month, the House Energy and Commerce Health Subcommittee convened for a hearing focused on the role of incentives in advancing treatments and cures, and whether current economic and regulatory incentives are sufficient to encourage robust research and development investment for innovative drugs and medical devices.

Upton summarized three main points he hopes the 21st Century Cures initiative will address: (1) he would like to see overall decreases in time and cost for the FDA process of approval; (2) he is in favor of extending patent exclusivity and a review of Hatch-Waxman; (3) he encouraged the refinement of the coverage and reimbursement process for medical devices in order to spur innovation.

Collaboration

"We need to foster better partnerships," notes Upton. "National Institutes of Health Director Francis Collins recently took a big step in this direction by announcing the Accelerating Medicines Partnership initiative, a new collaboration between the government and drug companies. Our FDA regulatory structure should also encourage greater collaboration among scientists, doctors, patients and big data analysts."

In a recent piece on the 21st Century Initiative, Jeffrey J. Kimbell, founder of Jeffrey J. Kimbell & Associates, a Washington-based consulting firm and Kenneth L. Hodge, Associate Director of Government Affairs & Legislative Policy with the firm, wrote that "the life-science community has a unique opportunity with...the 21st Century Cures Initiative to meaningfully impact the regulatory environment for future product development that meets the needs of patients today and tomorrow."

"This initiative has the makings of something groundbreaking," the article states, "and given Chairman Upton and the Energy & Commerce Committee's track record of tackling big problems, the entire health care community should be paying attention."

Comments

The committee welcomes the public's input and feedback to cures@mail.house.gov by July 22, 2014. 21st Century Cures is a truly collaborative effort. Please be advised that submissions sent to cures@mail.house.gov will be made publicly available on energycommerce.house.gov/cures as part of the effort to encourage continued discussion about opportunities and ideas to accelerate the pace of cures.

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