FDA Reform Effort In Congress Taking Expansive View
This article was originally published in The Pink Sheet Daily
Executive Summary
Energy and Commerce’s 21st Century Cures Initiative still focused on pharma even as it dives into communication and health IT.
Even when the House Energy and Commerce 21st Century Cures Initiative takes on topics that span the wider healthcare industry infrastructure and might seem more geared towards discussions of what constitutes a medical device or how to advance electronic health records, lawmakers seem to find a way to bring the drug development and approval process to the table.
Such was the case when House Energy and Commerce Health Subcommittee Chair Joseph Pitts, R-Pa., pressed Amazon VP of Global Public Policy Paul Misener July 17 on ways Congress could encourage technologies that will help increase efficiencies at FDA and other federal agencies to advance and speed development of new treatments.
Pitts was intrigued by Misener’s testimony at the joint meeting of the Health and Communications and Technology subcommittees, which discussed how FDA used cloud computing for data entry for the 900,000 handwritten adverse events reports its receives each year. Through a collaboration with cloud computing company Captricity, the agency turned the manual reports into machine-readable information with 99.7% accuracy, reducing costs from $29 per page to 25¢ per page.
“This cures initiative is in part focused on using technology to relieve administrative burdens for agencies such as FDA, so they can use the resources to invest in more research [and] new development methods, such as biomarkers. Do you have other suggestions for other ways we could increase efficiency at FDA and other agencies?” Pitts asked at the latest hearing of the 21st Century Cure Initiative.
The cures initiative is led by full committee Chair Fred Upton, R-Mich., who has spent minimal time at the project’s many congressional hearings since it kicked off in May. Upton plans to use the information gleaned to produce a bill that would modernize and accelerate U.S. biomedical innovation by the end of the year.
Hearings continue at a brisk pace. The July 17 meeting focused on how 21st century technology can enable 21st century cures. A hearing on July 22 will examine barriers to ongoing evidence development and communication, and July 23 brings a personalized medicine roundtable.
Technology: A Cure For Insufficient Funding?
If Congress can figure out ways to free up more public health agency resources, it could aide both industry and government. Regulators would have more money to advance new drug development models such as clinical trial networks or to research biomarkers that could allow for quicker drug approvals.
Lack of government funding and resources have been cited by both FDA and NIH leaders as key hurdles in advancing the drug development process and developing more innovative treatments at multiple 21st Century Cures hearings.
For example, FDA Center for Drug Evaluation and Research Director Janet Woodcock told Congress July 11 that FDA doesn’t have the ability to develop patient-reported outcomes for 7,000 diseases or hold that many patient-focused drug development meetings (Also see "Woodcock Encourages Patient Groups To Take Lead To Speed Regulatory Process, Development" - Pink Sheet, 11 Jul, 2014.).
But since the first 21st Century Cures round table May 7, Republican members of Congress have largely shot down the notion that more funding would come from the project, never mind the fact that increased appropriations is outside of Energy & Commerce’s jurisdiction (Also see "Congress Dives Into Biomedical Innovation: Will It Drown In A Deep Sea Of Competing Needs?" - Pink Sheet, 12 May, 2014.).
Pitt’s comments, however, indicate the committee does seem to be thinking about other ways it could help federal health agencies deal with a challenging fiscal environment.
Amazon’s Misener offered three ways Congress could accelerate the cycle of drug discovery, development and delivery through the use of cloud computing:
- Accelerate the discovery of new treatments by helping NIH establish and operate cloud-based data management platforms that will allow federally-funded researchers to share their data. Currently, while federally-funded researchers are required to share their data, they must fund, develop and operate their own data sharing platforms.
- Pass H.R. 967, the Advancing America’s Networking and Information Technology Research and Development Act, which would require an assessment of how federal science agencies can facilitate the use of cloud computing for federally-funded science and engineering research, and H.R. 1232, the Federal IT Acquisition and Reform Act, which would assist federal agencies with healthcare, research and scientific missions to improve their technology capabilities and efficiencies.
- Work with HHS to modernize implementation of the Health Insurance Portability and Accountability Act (HIPPA) so healthcare providers can readily employ benefits of cloud computing without compromising privacy protections.
Misener said the government needs to relook at how it sets aside money for information technology so that agencies like FDA can use funds for the most efficient technologies.
“Typically a roadblock we’ve come up with over the years in trying to serve government, including federal government, is there is often money set aside to buy computers and software,” Misener said.
Agencies are given authority only to buy specific things like hardware or software instead of having the freedom to obtain technological services that can save both time and money in the long run, and can make it easier for the government to utilize the newest technology as it becomes available, he explained.
“Instead money could be allocated for purchasing services, an operational cost rather than a capital investment,” he said.
Pharma Getting Into The Cloud
Scientists should be doing science, Misener told “The Pink Sheet” DAILY, “not figuring out how to store data.”
Regarding the cloud computing bills, Misener said both “are important pieces of legislation” that could also set an example for local governments, private industry and other countries “that there is a great deal of efficiency that can be gained from the cloud.”
Some big name pharmaceutical companies also are benefiting from cloud computing, Misener noted.
In 2013, Novartis AG used cloud computing to screen 10 million compounds against a large molecule they discovered that is involved in the disease mechanism of a certain type of cancer.
Novartis didn’t have the capacity in their data center to do this type of testing and building that infrastructure would have cost an estimated $40 million, Misener told Congress. Instead, the company built a virtual high performance computing center in the cloud, allowing the company to perform the equivalent of 39 years of science in less than nine hours for a cost of $4,200.
“In the process, they identified three compounds that may be able to interact with the large molecule they were targeting.”
Merck & Co. Inc. also used cloud computing to figure out what was causing higher than usual discard rates for certain vaccines in the summer of 2012.