The FDA Releases Enhanced Regulatory Initiatives for Drug Compounders

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have compounded; (2) publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key regulatory information applicable to outsourcing facilities; and (3) conducting the sixth intergovernmental meeting on drug compounding allowing intergovernmental agencies to coordinate their regulatory efforts for all compounders. These efforts demonstrate that FDA is continuing to actively oversee the regulation of drug compounding and is looking to work closer with state boards of pharmacy to coordinate its various enforcement initiatives. Drug compounders should continue to closely monitor their compliance with all applicable state and federal regulation and guidance.

For more information on this important topic, please read the full client alert here.

Upcoming Free CLE Webinar: “3D Printing: Component Parts/Raw Materials Product Liability & Health Risks”

Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into patient care. Our 3D printing team has authored two white papers (available here and here) on the subject, and we’re now pleased to bring you another complimentary CLE webinar on the issue. Reed Smith associate Michael Mandell, along with colleagues from Exponent, will be hosting this event, “3D Printing: Component Parts/Raw Materials Product Liability & Health Risks,” on October 5, 2017 at 12 p.m. ET.

The webinar will focus on selective laser sintering, which is among the more widely used 3D Printing/Additive Manufacturing technologies for industrial applications. The medical device industry is currently adopting this technology for the manufacture of patient-specific cranial implants, maxillofacial implants, spinal cages, hip-cup implants, surgical tools and guides, and prosthetics, and more. The use of powder introduces a range of damage risks, not to mention health concerns, that warrant attention for the additive manufacturing of parts, including the source supplier, additive manufacturer, trained personnel of the machine, and the end consumer.

The presenters will discusses the potential liability of suppliers of such powders and their available defenses, as well as the various risks, potential consequences, and plausible sequence of events that can result in injury to nearby workers or those implanted with the final product.

This webinar is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy. To register for the free webinar, please click here.

FDA Clarifies Trading Partners Under the DSCSA

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers or 3PLs.

Since November 2013, when the DSCSA became law, many clients have been concerned about whether and the extent to which the DSCSA applies to certain segments of the pharmaceutical supply chain industry. Other clients have been concerned about how to satisfy applicable DSCSA requirements for being considered an “authorized” trading partner, and whether some partners – such as solutions providers and logistics and administrative services contractors – should be considered a DSCSA trading partner at all.

The FDA’s draft guidance helps to address many of these concerns. Among other things, it clarifies the applicability of DSCSA requirements to entities that take part in the distribution of prescription drugs in the United States. It also explains when and whether such entities are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an “authorized” trading partner in the drug supply chain, as defined by the DSCSA. Continue Reading

Germany – A Major Hub for Patent Litigation

With the Unified Patent Court now stalled for at least the near future, U.S. life sciences companies will continue to face the question of where to bring patent infringement cases in Europe. The German courts offer a variety of potential advantages for such companies.

Two-thirds of all patent infringement cases in Europe are brought to Germany, and there are many reasons for this – including that Germany has courts with specialized judges who exclusively practice patent law.  For patent-holders, another key reason is that, under German law, injunctions are granted as of right:  If the court finds in favor of the patentee, it will issue an injunction. There are of course significant other benefits to litigating patent disputes in Germany — including the fact that, as a rule of thumb, first-instance proceedings only take between eight and 24 months.

For more information about patent litigation in Germany, and the benefits it can offer U.S. life sciences companies, please read my recent Reed Smith client alert, “10 Questions You Always Wanted to Ask About Patent Litigation in Germany.”

Reed Smith Partners to Speak at Upcoming “Women Leaders in Life Sciences Law Conference” – July 20-21

Two members of Reed Smith’s Life Sciences Health Industry (LSHI) group will be speaking at the American Conference Institute’s 4th Annual Conference on Women Leaders in Life Sciences Law taking place in Boston on July 20-21, 2017.

On Thursday, July 20, 2017, Reed Smith Partner Katie Pawlitz will be a panelist for the conference’s “Year in Review: 2016-2017 Legal Updates by Practice Area” session, which will review the most important case law updates and enforcement initiatives of the past year that every life sciences professional needs to know.

Later that day, Reed Smith Partner Gail Daubert will discuss reimbursement – including coverage, coding, and payment – in an evolving environment as part of a panel on “Latest Business Initiatives and Their Legal Implications.”

Continue Reading

Upcoming Free CLE Webinar: “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”

The Reed Smith life sciences product liability and 3D printing teams will be hosting an upcoming CLE webinar “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8, 2017 at 12 p.m. ET. Reed Smith presenters Jim Beck and Matt Jacobson will be discussing 3D printing’s potential impact on product liability laws as the technology becomes faster, cheaper, and more widespread.

Webinar attendees will learn about possible alternative theories that plaintiffs may advance when someone is injured as a result of a design or manufacturing defect in a 3D printed product. Particular attention will be given to the impact of 3D printing on FDA-regulated prescription medical products. Finally, attendees will hear an examination of various strategies that companies or potential product liability defendants – traditional and non-traditional – might use, prior to litigation, to minimize their possible exposure and mitigate the risk of liability.

This webinar is also approved for 1 hour of general CLE credit in CA, IL, NJ, PA, TX and WV. To register for the free webinar, please click here.

Lessons from the Competition Appeal Tribunal Hearings in Merricks v. MasterCard and Gibson v. Pride Mobility Scooters

The UK held the first two hearings under its new opt-out class action procedure. The precise rules governing UK class actions will be developed over time from the general guidelines in the statute. There are significant similarities between the U.S. and UK rules on a number of topics related to collective proceedings, and barristers and judges alike cited U.S. law at the recent hearings. The critical questions faced by plaintiffs and their experts at the hearings reflect significant hurdles for the plaintiffs and insights about future claims that might face an easier path to continue as collective proceedings. Additionally, the UK’s current rules allow only competition law claims to proceed as class actions, but class actions may be available for other types of substantive legal claims in the future.

For more information, please read our Reed Smith client alert.

New Regulations Reshape Transparency-Related Obligations in France, Could Impact Life Sciences Companies

In France, transparency requirements are regulated by two main sets of laws: “The French Anti-Gift Law” regulates the provision of gifts, discounts and other incentives to health care providers by life sciences companies, while “the French Sunshine Act” imposes disclosure obligations on companies relating to benefits granted to, and agreements concluded with, health care providers.

While the French Sunshine Act has been frequently amended to reflect subsequent changes brought by implementing decrees, orders, and circulars, the Anti-Gift Law has been less subject to change, at least until now.

The recently-adopted Ordinance No. 2017-49 aims to extend the scope of the Anti-Gift Law, modify transparency procedures, and double fines for non-compliance, all of which could significantly affect life sciences companies,

For a detailed look at these changes and discussion of their impact, please read our client alert, “France: Again the life science industry will have to take a close look at a new set of regulations reshaping transparency-related obligations.”

Final Rule on Amending the Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules on Beneficiary Inducements

On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules prohibiting beneficiary inducements. These changes protect certain practices and arrangements from criminal prosecution or civil sanctions under the AKS and/or the CMP law. The rule finalizes, with certain modifications, all of the AKS safe harbors and beneficiary inducement CMP exceptions noted in a proposed rule published on October 3, 2014.

To learn more about the final rule, read our Reed Smith Client Briefing here.

Unified Patent Court Could be Operational as Early as December 2017

As we discussed in a prior post, the introduction of the Unified Patent Court (UPC) will be a significant change to the European patent landscape and will have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement.

Consequently, life sciences companies should take note that the Unified Patent Court (UPC) Preparatory Committee announced last week that it is now working on “the assumption that the Provisional Application Phase (PAP) will start end of spring 2017, presumably in May, and that the Agreement on the Unified Patent Court (UPCA) can enter into force and the court become operational in December 2017.” (The timetable does come with the “clear disclaimer that there are a number of factors that will dictate whether it is achievable.”)

What does this mean for patent owners? Some practical points include the following:

  • The UPC Preparatory Committee specifically announced that the start of the sunrise-period for opting out European patents from the UPC system will be in early September 2017. This will provide a minimum of three months for patent owners who wish to opt out their patents to do so before the UPC becomes operational in December 2017.
  • This is the first time even an indicative date has been given to the start of the opt-out sunrise period. Patent owners should therefore prioritize their analysis of their portfolios to identify which patents should be opted out, if any.
  • Patent owners should also be reviewing patent licenses and the extent to which licensees can unilaterally litigate in the UPC without needing the patent owner’s permission, as commencing litigation in the UPC will subject the patent to the UPC’s jurisdiction. Any such licenses will need to be amended.

For more information on the Unified Patent Court, its impact for patent owners, and factors that could affect its timeline to being operational, please read my recent Reed Smith client alert, “Provisional start date announced for the Unified Patent Court.”