Public Policy

Legislation for a national pharmaceutical track-and-trace system gained steam on the Hill this week. On Friday, the House Energy and Commerce committee approved its version of the track-and-trace legislation, H.R. 1919. Yesterday, right on the heels of the House, the Senate Health, Education, Labor and Pensions Committee approved their own version of the legislation, S. 957, and then combined it with new compounding legislation. 

Each bill aims to create an interoperable, electronic, unit-level tracing system for the U.S. drug supply chain aimed at protecting people from fake medicines, recalls, and stolen or expired medicines. Both bills seek to accomplish this goal in a step-wise and scalable manner to ensure it will be implemented by different parts of the supply chain in staggered way. The work begins immediately and eventually will lead to a full track and trace system with roles for each stakeholder in the supply chain, from manufacturers that make the drugs to the pharmacists that dispense them to patients. 

There are some differences in the two bills, but both contain the underlying principles and requirements that will improve drug safety in the United States with a comprehensive, national system. The bills go a long way toward the development of a single, national system to follow medicines as they travel through the supply chain. By strengthening the chain, these bills will help provide patients with peace of mind on the safety and efficacy of their medications. 

Lilly joins other supply-chain stakeholders in congratulating Chair of the Energy and Commerce Committee, Representative Fred Upton, Senate HELP Committee Chairman Harkin and Ranking Member Alexander as well as Senators Bennet and Burr and other Congressional champions of these bills on this great accomplishment. We applaud this milestone and look forward to working with Congress as they partner to improve and eventually pass the legislation into law.

Medicare Part D currently provides over 35 million older Americans improved access to their prescription medications. Yesterday, the Senate Special Committee on Aging brought together policy experts to discuss Medicare Part D’s performance in the decade since it became law. Reflecting back on the last 10 years, it becomes clear that Part D works. Medicare Part D provides beneficiaries with quality, cost-effective care and helps to improve the sustainability of the entire health care system.

Ranking Member Susan M. Collins noted that the Part D program is “extremely popular and working very well.” According to recent surveys, an astonishing 94% of Part D enrollees say they are satisfied with their coverage, and 95% feel confident that their coverage meets their needs. However, Senator Collins cited concerns that a lack of education and awareness of Part D may lead older Americans to choose plans that do not best suit their lifestyles. As Senator Collins emphasized, providing more targeted assistance can help ensure that beneficiaries choose plans that best meet their financial and health needs.

Greater choice for beneficiaries choosing their Rx drug plans helps ensure that competition will keep prices low and quality of care high. It is this free market balance that has made Part D an effective program over the last decade. Speaking before the committee, Research Professor at Georgetown University’s Health Policy Institute, Jack Hoadley, PhD outlined four successes of Medicare Part D:

• The cost of Part D has been lower than expectations
• Part D has reduced costs and increased access for enrollees
• The Part D coverage gap is being fixed
• Despite initial concerns, the program’s launch went smoothly

Medicare Part D has proven time and again that health policy can provide quality care and be fiscally sound. Yet despite these successes, proposals continue to threaten the balance of choice, competition, and free market principles that make this policy viable. As Executive Vice President for Policy and Research at the Pharmaceutical Research and Manufacturers of America, Richard Smith emphasized, “There is no justification for imposing price controls on a Part D program that has achieved a strong record of cost containment, beneficiary satisfaction, and improved health outcomes.” As the months lead up to Medicare Part D’s 10 year anniversary, we look forward to more discussion about how we protect this model program that work for patients. As Chairman Bill Nelson said at yesterday’s hearing, “We can work together to ensure that no senior ever has to leave the pharmacy without the drugs they need.” 

Tomorrow, the Government of Peru will host stakeholders from around the world during the 17^thround of negotiations on the Trans-Pacific Partnership (TPP). The TPP provides an opportunity to strengthen U.S. trade relationships in one of the most robust, dynamic regions in the world. The White House has cited the TPP’s potential to create a truly 21^st century trade agreement. But what does that really mean? When we talk about a 21^st century trade agreement and gold-standard intellectual property protections, it may sound like science fiction, but it has very real implications for the United States and partner countries...

Around the world, illegitimate drugs, whether fake, falsified, or substandard, pose a significant threat to patients. While many think of illegitimate drugs as a problem unique to developing countries, over the last few years, the United States has seen numerous incidences of these illegitimate medications making their way into the legitimate supply chain and into the hands of patients. Over the last few weeks, both the House and Senate have demonstrated strong commitments to strengthening our supply chain and protecting patients through the development of national track-and-trace standards.

In the Senate, Chairman Harkin, Ranking Member Alexander, and Senators Bennet and Burr submitted draft legislation to the Committee on Health, Education, and Pensions. In reference to the need for national track-and-trace standards, Senator Bennet remarked, “Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves. In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death.” This bipartisan move represents a promising step toward the kinds of standards necessary to ensure patients receive safe and effective medicines. However, the Senate isn’t the only side of Congress recognizing this critical need...

In my recap blog from Day 2 of the BIO International Convention, I highlighted the use of big data in health care. A couple of the panelists and speaker noted that while big data provides immense opportunities, realizing its potential requires mechanisms for interpreting and acting on this new information.  As the third day of the Convention comes to a close, I find myself in the same situation as many of these researchers, confronted with extraordinary amount of new knowledge and looking for a way to make this information actionable...