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New Government Compliance Requirements Create Outsourcing Opportunity for Pharmaceutical Manufacturers

DSCSA Deadline and Changing Government Pricing Policies Prompt Partnerships To Increase Efficiency

Boca Raton, FL (July 16, 2018) — Conventional pharmaceutical manufacturers are being challenged to increase innovation and reduce costs.  During the past several years, this new financial reality resulted in the development of the virtual manufacturing business model and has increased outsourcing of tasks including government pricing programs traditionally managed internally.

A 2016 study1 about this practice found 80% of biopharma companies reported increased alliance activity with outsourcing partners compared with 2011 levels.

As manufacturers export key business functions to outside resources that generate cost savings, it is important that the partnerships between manufacturers and third parties operate smoothly and create additional efficiencies.

In a recent client survey, WDSrx – Woodfield Distribution, LLC, a Logistics Services Provider specializing in pharmaceuticals, health and wellness products, learned that government pricing and serialization services are immediate priorities earmarked for transition to an external solutions provider.

As a trusted partner with pharmaceutical manufacturers since 2010 managing warehousing, storage, order fulfillment, transportation management, financial services, reverse logistics, packaging and labeling, WDSrx recently introduced upgraded capabilities for government pricing and serialization programs.

CAST YOUR VOTE FOR COMPLIANT MANAGEMENT OF GOVERNMENT PRICING

Government pricing program management covers a wide range of options far beyond monitoring changing regulatory requirements.  WDSrx has instituted new solutions for manufacturers that detail the effect of government programs to their bottom line including reimbursement rates to providers and expected discount levels.

The new suite of WDSrx government program solutions was developed with IntegriChain, the industry leader in government pricing and contract management. IntegriChain simplifies the process of managing government pricing in compliance with current and proposed regulatory changes from the Centers for Medicare and Medicaid Services (CMS). This offering also covers the impact of new policies related to the Affordable Care Act, including the 340B Drug Discount program, Health Insurance Exchanges and Accountable Care Organizations. The IntegriChain program also includes government and commercial rebate processing.

“We are excited to partner with WDSrx on government pricing, contract management, and rebate processing,” said David Weiss, Executive Director of Industry Solutions for IntegriChain. “This offering addresses bio/pharma manufacturers’ government pricing challenges—including complex calculations, data management, and large investments in systems and processes—as well as its risks—including compliance risk, financial risk, and the risk of managing regulatory change.”

“Manufacturers want a simple solution to handle complex government pricing requirements,” according to WDSrx Business Development Manager Sam Seelenfreund.  “They are receptive to the WDSrx practice that provides a single point of contact for robust government pricing compliance and logistics services with proactive business analysis.”

LAST-MINUTE DSCSA COMPLIANCE SOLUTIONS

The Drug Supply Chain Security Act (DSCSA), passed into Federal law in 2013 and being implemented over a ten-year period ending 2023, mandates a system to improve current means of tracking prescription drugs within the pharmaceutical supply chain to increase product security for patients.  The legislation reaches a milestone on November 27, 2018, the deadline for manufacturers to switch to new labeling protocols, hardware and software requirements or risk penalties from the Food and Drug Administration (FDA) for non-compliance.

Manufacturers that choose to outsource their DSCSA compliance program work with WDSrx for a comprehensive solution that minimizes time and resources for the manufacturer at a favorable rate compared with the capital investment required for in-house DSCSA compliance. WDSrx partners with TraceLink, a global leader of serialization solutions through its information sharing network platform, to provide a more economical and turn-key solution combining value with established industry leadership.

“Manufacturers that delayed their serialization programs must find a reliable partner to meet compliance prior the deadline,” states WDSrx President Adam Runsdorf.  “As an early adapter that completed upgrades in equipment, software and training for serialization, we are helping many manufacturers by providing the solution they need with the confidence we instill as a reputable pharmaceutical Logistics Services Provider.”

OUTSOURCING AND COST CONTROL

Government programs and serialization services are cost centers with potential volatile impact to the bottom line of pharmaceutical manufacturers.  The WDSrx business model is built to provide flexibility for manufacturers to scale resources and capabilities according to need, from a single logistics service to multiple healthcare supply chain solutions.

For further information contact Larry Hotz, Marketing Director, lhotz@wdsrx.com or 561.998-3885 x304.

1. Buvailo, Andrii. “Pharma R&D Outsourcing Is On The Rise.” The Rise of R&D Outsourcing in Pharmaceutical Industry | BioPharmaTrend, 10 Mar. 2017, www.biopharmatrend.com/post/30-pharma-rd-outsourcing-is-on-the-rise/.

 

About Integrichain

IntegriChain is a leading healthcare technology company for bio/pharma manufacturers, uniquely employing world-class data science that integrates all core elements of access data to deliver analytics and managed services that help patients start and stay on therapy. Today IntegriChain is the trusted partner for all Top-10, 16 of the Top-20, and more than 80 other bio/pharma manufacturers.

About Tracelink

From some of the largest pharmaceutical brands in the world—to those still seeking approval for their first commercial products, drug manufacturers of all types have embraced the TraceLink network as the platform for transforming their supply chains into digital networked ecosystems that accelerate the production of serialized products.

Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at jsolomon@wdsrx.com or (561) 998-3885 x316.