July 9, 2014
With summer upon us and the midterm elections just a few months away, it has been a fast and furious few months of work for us at HDMA to get our priorities — such as prescription drug abuse and DEA enforcement efforts — front and center before lawmakers.
As I mentioned in March, HDMA was ramping up its support for the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, an important piece of the larger strategy to address prescription drug abuse in the U.S. In May, Reps. Tom Marino (R-Pa.) and Marsha Blackburn (R-Tenn.), along with Reps. Peter Welch (D-Vt.) and Judy Chu (D-Calif.), reintroduced this legislation as H.R. 4709.
The addition of Reps. Welch and Chu as original Democratic co-sponsors strengthens the bill considerably and demonstrates the bipartisan concern for this public health crisis. We are particularly grateful to Meg Glazier of Burlington Drug Company for her efforts to secure Rep. Welch as a co-sponsor.
Originally introduced as H.R. 4069 by Reps. Marino and Blackburn in February, the legislation further defines key terminology in the Controlled Substances Act (CSA) to better delineate distributor responsibilities under the law. It also provides DEA-registered companies the ability to submit corrective action plans to address agency concerns (similar to the way drug manufacturers interact with the FDA).
Testifying on the legislation before the House Energy and Commerce Health Subcommittee in April, I noted it will foster greater collaboration, communication and transparency between industry stakeholders and regulators — especially the DEA — and allow industry and regulators to enhance their partnership to address prescription drug abuse and diversion. Most importantly, the legislation also will ensure that legitimate patients continue to receive the medications they need.
Within the reintroduced legislation, the original requirement for manufacturers and distributors to conduct mandatory background checks was removed. Additionally, instead of establishing a Prescription Drug Working Group, the bill now calls for HHS, in consultation with the DEA and Office of National Drug Control Policy (ONDCP), to submit a report to Congress. This report will detail the effect of federal and state law enforcement strategies to prevent prescription drug abuse and diversion on patient access; and identify ways industry stakeholders and these agencies can better work together to address this problem.
H.R. 4709 was approved by the House Energy and Commerce Subcommittee on Health and the full Energy and Commerce Committee on May 28 and June 10, respectively. While the bill has yet to be considered by the House Judiciary Committee, we are hopeful that the momentum behind it continues. Additionally, HDMA is working to secure the introduction of a Senate companion bill this year.
HDMA also continues to be engaged on prescription drug abuse as part of a stakeholder coalition, The Alliance to Prevent the Abuse of Medicines, to recommend comprehensive solutions to help mitigate this problem. At a policy briefing in April, The Alliance presented nine legislative concepts, ranging from adopting a public health approach to educating the public and promoting a federal take-back program.
Turning to pharmaceutical traceability, HDMA's Traceability Implementation Working Group is working hard to ensure that the historic 2013 traceability law [the Drug Supply Chain Security Act (DSCSA)] is implemented as efficiently as possible. In May, HDMA released an update to the 856 Advance Ship Notice EDI Guidelines for the DSCSA, followed by a webinar co-hosted by HDMA and Axway on June 17. (As part of our Traceability Webinar Series, HDMA held a similar educational webinar with the FDA's Connie Jung in April.) Another update to these guidelines is expected in the next month.
The working group also is creating a transaction scenarios document, presenting HDMA's interpretation of how physical product, product ownership and data move between trading partners under a variety of product transaction scenarios; as well as the requirements for trading partners to pass information under the DSCSA.
Finally, we are once again hosting our popular Traceability Seminar on November 10–12, which will bring you up to speed on the implementation process. More information on this seminar can be found on our website.On the international front, HDMA continues to plan its first-ever International Pharmaceutical Distribution Conference, which we are hosting with our Chinese counterparts, the China Association of Pharmaceutical Commerce, on October 22–23 in Beijing, China.
Hosting this meeting is a natural extension for us as an organization. Much like our Distribution Management Conference, the conference will provide education sessions on a variety of topics, with sessions ranging from "Global Standards in the Pharmaceutical Supply Chain" to "Managing Consolidation" and "Facility and In-Transit Security."
Last, but certainly not least, HDMA hosted its annual Business and Leadership Conference earlier this month in Phoenix, with more than 750 pharmaceutical supply chain executives in attendance — our most attended to date. Former Defense Secretary Dr. Robert Gates and Dr. Eric J. Topol of the Scripps Translational Science Institute provided insightful keynote addresses, and more than 3,100 one-on-one business appointments were held. We also welcomed a new member to the HDMA Board of Directors, Tim Booth of Metro Medical Supply. Michael Conley of Novartis joined as a Board member for our foundation, the Center for Healthcare Supply Chain Research.
One of the meeting highlights was the annual presentation of the Nexus Award for Lifetime Achievement to David Moody of Mutual Drug. A former HDMA Chairman, David has shown true passion to our industry in his roles as a community pharmacist, an industry advocate and educator to dozens of future pharmacists. We are thrilled to recognize him as the 2014 Nexus honoree, and HDMA and the Center congratulate him on this prestigious achievement.
John M. Gray
President and CEO
HDA is the national association representing primary healthcare distributors, the vital link between the nation’s pharmaceutical manufacturers and healthcare providers. Each business day, HDA member companies ensure that over 15 million prescription medicines and healthcare products are delivered safely and efficiently to more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. HDA and its members work daily to provide value and achieve cost savings, an estimated $42 billion each year to our nation’s healthcare system.