Fuerst Ittleman

Upcoming Compliance Deadline: FDA’s Electronic Requirements for Medical Device Reports

The U.S. Food and Drug Administration’s (FDA’s) deadline to comply with the new medical device reports (MDRs) rule is fast approaching. By August 14, 2015, mandatory reporters, which are primarily medical device manufacturers and medical device importers, must comply with the FDA’s new electronic submission rules.
The FDA utilizes several postmarket surveillance mechanisms to monitor the safety and performance of the medical device industry. Medical device reporting is one of these mechanisms. Pursuant to 21 C.F.R. part 803, required reporters, including manufacturers and importers, must submit reports to the FDA when certain adverse events and device problems occur. For instance, device manufacturers have a reporting duty when they discover that a device they have manufactured may have caused or contributed to a serious injury or death. Likewise, if a manufacturer learns that its device would be likely to cause a death or serious injury due to malfunction, the manufacturer is required to submit a report to the FDA.
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In The Headlines

The Trans-Pacific Partnership Provides Opportunities for Expansion in the Asia Pacific Region

With several new trade agreements aimed to expand and simplify the trade process, there is an unprecedented opportunity for North American pharmaceutical companies to expand their business into emerging markets.

One of the most significant of these opportunities is the Trans-Pacific Partnership (TPP), which if passed, is expected to bring several economic benefits to small and large U.S. businesses and open the door to trade in the Asia Pacific region.

Under negotiation since 2008, the TPP is a free trade agreement involving 12 countries that represent $28.1 trillion or almost 40% of global GDP. The TPP includes; Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.

The agreement aims to:

  • Lower or eliminate tariffs and non-tariff barriers on a variety of products to help large and small businesses sell and export to overseas companies.
  • Provide an investor-state dispute settlement process.
  • Protect intellectual property rights.
  • Synchronize e-commerce including data flows and electronic transaction authentication, as well as intellectual property protections.
  • Streamline supply chain and customs procedures.
  • Create a “living” agreement, which will allow for updates as new trade issues emerge and will enable other countries to be part of TPP.

Businesses with global sourcing can take advantage of liberalized trade to actually benefit on both ends. For example, US manufacturers that depend on TPP sourcing can get the components needed to produce final products at an economical price from TPP countries and then export the goods back to TPP customers.

How will the TPP affect pharmaceutical companies?

The negotiating TPP texts have not been made public and there is wide speculation on what will be included, especially when it comes to the pharmaceutical industry.

While there is much we don’t know about the TPP, reports from the office of the United States trade representative state that the pharmaceutical intellectual property provisions seek to promote innovation and the development of new, lifesaving medicines; create opportunities for generic drug competition and ensure the affordable access to medicines.

The World Trade Organization (WTO) oversees the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an agreement where all participating nations, including the U.S., agree to honor 20-year drug patents. Under TRIPS, countries that can’t afford to manufacture drugs they need are able to acquire a compulsory license, allowing them to bypass another country’s patent and import patented, brand-name drugs at generic drug prices. This means developing countries have access to these medications now.

However, there is speculation that pharmaceutical patents under the TPP could have much stronger protections for drug companies than what is currently in TRIPS. For example, patents could be extended beyond 20 years, essentially delaying when generic drugs go to market.

Although negotiations and speculation of what will be included in the final TPP continue, there are steps pharmaceutical companies can take now to prepare for the TPP and other pending trade pacts.

How to Prepare Now for the TPP

With the unprecedented number of trade pacts and continued globalization of the supply chain, it is vital that businesses seeking to trade remain agile. To do this, businesses need to stay up to date on trade news and understand the opportunities and risks they present to their business.

In advance of TPP passage, businesses seeking to trade with these 12 countries will need to ensure that the trading partners are part of their strategic plans, both for their manufacturing location and component sourcing strategies.

Taking advantage of a trade program means companies must analyze their manufacturing locations and supply chains to those sites.  This analysis requires reliable data, including bills of material, costs and supplier information, as well as subject matter experts who can apply this information to the TPP rules of origin when they are finalized.

Businesses should begin thinking about how to quickly amend their supplier contract terms and conditions to include language regarding participating in and compliance with TPP.

While keeping up to date with these regulations and new agreements can seem daunting, a global trade management business partner can be a company’s trusted advisor and help navigate the trade landscape. It is important to work with foreign suppliers, brokers, and customs experts in advance of making trade preference claims, especially under a new program. A global trade management company will do the data analysis for a company and simplify the trade process.

Topic of Discussion


Increasing ROI for Digital Tactics from the Inside Out

Measuring the ROI of approved digital tools once they are in the marketplace is a hot topic.
The quest to generate a high ROI is an ongoing one and metrics to measure success in digital are often debated. What should not be debated, however, is the value of increasing a company’s ‘internal ROI’ when readying digital tools for promotional review. ‘Internal ROI’ reflects the efficient use of time and money spent internally getting digital promotion approved for use in the marketplace.

This is only possible when Marketing and review team members collaborate upstream before a digital tool is even submitted for approval. Perhaps if we spent more time collaborating earlier in the process, we would deliver a higher ROI from the inside out.

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