New sample reporting requirements will be a focus of this year's meeting
The PDMA Sharing Conference, organized by the PDMA Alliance and now in its 22nd year, will be held in National Harbor, MD, on Sept. 19—21. While every year’s meeting brings out new technologies, new service capabilities and new regulatory practices, this year’s meeting is especially timely due to the schedule for compliance with the Physician’s Sunshine Act, a part of the Affordable Care Act of 2010. While that act, now written into law as Public Law 111-148, was focused primarily on patient insurance and Medicare/Medicaid provisions, it also included the so-called “aggregate spend” rules that will require reporting of “transfers of value” from pharma manufacturers to healthcare providers and GPOs. And part of those aggregate spending rules are now codified as Sec. 6004, the “prescription drug transparency” clause, requiring a report of sample distribution, by quantity and by healthcare provider, to FDA. Under the Prescription Drug Marketing Act, manufacturers have been required for years to account for how much sampling they do; now they are required to report precise amounts by physician.
Manufacturers, and the service providers who design and fulfill sampling programs for them, were scrambling to meet an Apr. 1 deadline for beginning to report these data, but on Mar. 28, FDA postponed the deadline until Oct. 1. “FDA does not intend to object until at least October 1, 2012, if manufacturers and ADRs [authorized distributors of record] do not submit information under Section 6004, and we intend to provide notice before revising our exercise of discretion with respect to compliance.” PDMA compliance managers are not off the hook; but the additional time will enable them to better organize their reporting functions.
That Oct. 1 deadline comes just after this year’s Sharing Conference—the timing could not be better for PDMA managers making their final reporting preparations. Based on its preliminary program, PDMA Alliance is scheduling a session on sample transparency specifically, along with its customary “PDMA 101” training sessions. A Town Hall Forum, a usual part of the Sharing Conference agenda, will also be held with top administrators from FDA’s Office of Compliance.
But the sample-management business has many other drivers: new technology in the form of alternative sampling (online and elsewhere); how sample accountability fits into an overall aggregate spend compliance function; and broader issues of supply chain security, dealing with drug shortages, and state-level regulatory requirements. The advances in customer-relationship-management software both create opportunities and challenges for sample accountability programs; in particular, how sample distribution can fit into an overall multi-channel marketing program.
Both for compliance purposes and to meet business goals, the management of customer master data is well presented at the PDMA Sharing Conference. Service providers in this area continue to advance their data-scrubbing and analytical capabilities, and have moved aggressively into managing email programs for communicating with healthcare providers.
A welcoming reception will be held the evening of Sept. 19, at the Gaylord Hotel and Conference Center; and provision is being made for attendees to come earlier or stay later at the hotel for travel in the Washington, D.C., area.
A list of early signups for exhibitors follows. More information is available at pdmaalliance.org.
PDMA Sharing Conference Exhibitors
(as of June 1)
Advantage Management Solutions, Inc.
Customer data management services and regulatory compliance; proactive compliance support.
Cegedim Relationship Management
Customer relationship management solutions; sample accountability; practitioner master data.
Compliance Implementation Services
Regulatory compliance strategies for global clinical R&D, manufacturing, commercial compliance and government programs.
Database marketing services; planning and creative marketing services.
Extra Space Storage
National network of self-storage facilities.
G&M Health, LLC
Compliance management; IT validation; training and support.
Sample packaging, warehousing and fulfillment services.
Regulatory compliance services and training.
Healthcare Data Solutions
Master practitioner data lists; continuous data validation.
Howell Marketing Services
VAWD-accredited drug fulfillment and distribution; literature fulfillment; kitting and assembly; direct mail.
J. Knipper and Co., Inc.
Sample management and accountability systems; multi-channel marketing; AMA database services.
MedPro Systems LLC
Healthcare licensing data services; IT-based licensing data management.
Alternative sampling; e-sampling; sample fulfillment; direct-to-consumer and patient assistance programs.
Priority Solutions International
Sample fulfillment and distribution; inventory management.
Inventory management services; sample accountability and audits; fleet inspections.
Sample fulfillment services; global logistics management.
Customer relationship management (CRM) tools.
Consulting and advisory services on commercial operations.