FDA finalizes guidance on voluntary recalls, issues recommendations for industry

The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall.

The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable responsibilities on industry members or FDA staff. Instead, the guidance provides insight into the approach that FDA will take in working with industry to initiate voluntary recalls of products subject to FDA jurisdiction.

The guidance breaks the voluntary recall process into four aspects: 1) how a firm in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall; 2) what a firm should do if it discovers a problem with a distributed product; (3) how a firm should initiate a voluntary recall; and (4) how the FDA will work with a recalling firm to initiate a voluntary recall in a timely fashion.

Firms in the product distribution chain

The FDA guidance tells firms in the product distribution chain that it is critical that they be “recall ready.” That is, firms should prepare for the possibility of a recall before a recall is actually initiated.

To accomplish this, the FDA urges firms to start establishing the framework for their recall team. That involves identifying and training appropriate personnel to be involved in a recall and to establish an internal and external communications plan about the recall, informing the FDA, direct accounts, and the public.

Additionally, firms are encouraged to prepare for the logistics of a recall. That includes identifying any reporting requirements for distributed products, using adequate product coding, and maintaining distribution records to facilitate the location of products being recalled.

Finally, firms in the product distribution chain should create a set of written procedures for a possible recall. This will allow the firm to make a timely recall of all products on the market and limit the amount of time that any violative products remain on the market.

Problems revealed in a distributed product

The FDA guidance has recommendations for what firms should do if there is an indication that a product may be in violation of the Food Drug and Cosmetic Act or any of the other statutes that the FDA administers.

The guidance recommends that the firm take the following steps when problems are revealed with a product:

  • Identify the problem
  • Investigate the problem
  • Make decisions and take action
  • Consult with the FDA

Companies face decisions such as whether to initiate a voluntary recall, the scope and depth of that recall, and the need to discontinue the production/distribution of the product.

FDA in its guidance says it is available for consultation while the product is being investigated, and offers a comprehensive list of FDA recall coordinators on its website.

Initiation of a voluntary recall

In its guidance, the FDA recommends that firms initiate a voluntary recall by promptly notifying each of its affected direct accounts and by making some form of public notice, such as issuing a press release. It is this first communication, either to the public or to the direct accounts that the FDA considers to be the initiation date of the recall, regardless of what time may have elapsed during the investigation of the problem.

The FDA also urges firms not to wait for FDA review of its recall procedures or communications to initiate a recall. This is why the guidance in an earlier part recommends that firms establish recall procedures and strategies in advance to be ready to start the process and remove the violative products from the market.

The guidance also requests that firms immediately notify the FDA of any voluntary recall effort.

FDA interaction on initiation of voluntary recall

The FDA pledged to work cooperatively with firms initiating voluntary recalls. To that end, the agency provides recall coordinators who can help review firm communications and advise on the process of destruction, reconditioning or disposition of the recalled product.

Additionally, the FDA included warnings about how and when the agency might request a firm to initiate a recall and whether the failure of a voluntary recall to sufficiently address the problem with the product could lead to additional actions.

Reed Smith will continue to follow this and other developments. If you have any questions about regulatory issues in general or FDA product recalls specifically, please reach out to the health care lawyers at Reed Smith.

Join Us: Free CLE Webinar on the Best & Worst Drug/Medical Device Decisions of 2021

It’s that time of year again! The Reed Smith bloggers from the Drug and Device Law Blog will be hosting their annual CLE webinar, “The good, the bad, the ugly: the best and worst prescription drug/medical device decisions of 2021” on Friday, January 21, 2022 at 12:30 PM ET. 

Since 2013, Reed Smith’s contributors have hosted this exciting webinar discussing the top 10 best and worst decisions from the prior year. These cases are selected based on their likely precedential value, their importance to drug and device manufacturers, and their inherent (and subjective) merit. Bloggers Jim Beck, Stephen McConnell, Eric Alexander, and Rachel Weil will be presenting this year’s webinar and providing an in-depth analysis into these industry changing decisions. 

This program is presumptively approved for 1.5 CLE credits in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.

 You can register for the webinar here

Health care workers and private employees could be affected by new CMS interim final rule and OSHA final rule

On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule that requires vaccinations for certain health care workers. The rule is limited to only those entities who are surveyed by CMS and have Conditions of Participation, Conditions for Coverage, or Requirements for Participation in the Medicare and Medicaid programs. Our health care team recently summarized the rule, and is continuing to follow developments in this area.

In addition, our labor and employment team also provided a similar overview of the new Occupational Safety and Health Administration (OSHA) final rule. OSHA has issued its COVID-19 Emergency Temporary Standard (ETS) for private employers, which goes into effect on December 5, 2021, though as of this posting, the U.S. Court of Appeals for the 5th Circuit temporarily blocked the mandate while the court reviews it.

Please Join Us: European Life Sciences Legal Insights Month: 4 – 8, 27 October

Reed Smith will be presenting a virtual webinar series highlighting the numerous regulatory, litigation and transactional changes occurring in the European life sciences industry during the month of October. Our skilled life sciences team – joined by in-house counsel and industry professionals – will share their views on current industry developments.

Sessions include:

  • Multi-jurisdictional investigations in the life sciences sector – key updates from across the globe
  • Helping life sciences companies manage competition trends for post-pandemic success. A topical update on pay-for-delay practices, generics exclusion and price gouging
  • New legislative hurdles and unintended pitfalls: Regulatory considerations and strategies for global pharma and medtech companies
  • Access to data: Is harmonisation across the EEA achievable?
  • Listing on the LSE: experiences of U.S. life sciences companies
  • Doing business with research institutions: whose right is it anyway?
  • Deal making in the Life Sciences sector: how to successfully navigate the convergence of Intellectual Property and Competition Law

For more information or to attend any of these sessions, please click here to visit the registration page!

Here we go again – Unified Patent Court back on track

The German Constitutional Court issued a landmark decision with implications for many companies doing business in Europe on July 9, 2021. For decades, the European Commission and EU member states strived to create a pan-European Unified Patent Court (UPC). After overcoming many hurdles, any sensible commentator will be cautious in making statements about the future of the UPC. That said, for the first time in years it now appears that the pan-European patent litigation system may finally come into being. This is particularly relevant for companies from the life sciences sector that tend to enforce their blockbuster patents in parallel proceedings in the most relevant jurisdictions. The new system and the availability of pan-European injunctions means that claimants will be able to move from five parallel cases to one. However, the new system also comes with disadvantages such as pan-European invalidation proceedings. Nobody can predict the quality of judgments issued by the future court. For owners of European patents who are concerned about losing their IP rights, now is the time to identify the crown jewels and to make an informed decision about opting out.

To read more about the new provisions to PatG please read the client alert written by Dr. Anette Gärtner and Dr. Alexander R. Klett.

German Patents Act (PatG) Receives New Updates

Germany recently passed a reform bill for the Patent Act (PatG) and its new provisions will likely be coming into force sooner rather than later. The reform is particularly relevant for companies from the life sciences sector, which often litigate in this pro-patentee jurisdiction. The modifications to PatG address:

  • Confidentiality concerns. New section 145a PatG states the relevant provisions of the Trade Secrets Act will also now apply in patent infringement cases. In short, Germany extends the confidentiality club to patent proceedings.
  • Codification of the principle of proportionality, which currently leaves significant room for interpretation.
  • Implications. The reference to “third party interests” in the context of proportionality is not a welcome development, because it may limit the availability of preliminary and permanent injunctions. That said, we are yet to see how the courts will interpret the codified principle, and the open wording of the new provisions may enable judges to decide cases in a more flexible manner than is currently possible. The extension of the confidentiality club definitely is a step in the right direction, because it addresses potential concerns of litigants, which otherwise would not be prepared to disclose commercially sensitive information or technical know-how in court.

To read more about the new provisions to PatG please read the client alert written by Dr. Anette Gärtner and Dr. Alexander R. Klett.

A multi-agency pharmaceutical task force looks to review antitrust issues that arise during mergers and acquisitions

A task force, composed of key antitrust enforcement agencies including the Federal Trade Commission (FTC), and the Canadian Competition Bureau, is seeking information from the public regarding the effects of pharmaceutical mergers. This information will be used to update the practices for future pharmaceutical mergers by the task force’s constituent agencies. 

Following concerns within the agencies that their current practice of reviewing pharmaceutical mergers ignores the competitive landscape in the sector, the new information collected from the public will better address all anticompetitive effects from pharmaceutical mergers and acquisitions. The task force will use these new ideas to understand when concerns are likely to arise and when to challenge and oppose problematic mergers. 

For further information, please see this recent client alert by Reed Smith partners Ross Mackenzie, Michelle A. Mantine, and Isabelle Rahman

Join Us: Virtual Life Sciences CLE Week for In-House Counsel: November 9-13

Reed Smith is pleased to present a virtual life sciences CLE week from November 9 – 13, covering hot litigation and regulatory topics of interest to our pharmaceutical, biotech, and medical device clients. Sessions include:

  • The ABCs of an MDL: Lessons learned through the lens of a case
  • The benefits of arbitration for life sciences and health care industry disputes
  • Albrecht and implied preemption – Is there any clear evidence where we go from here?
  • Best practices and war stories from remote litigation and arbitration
  • Pharma’s evolving relationship with telehealth
  • Current trends in False Claims Act and antitrust enforcement

Each webinar in this series is presumptively approved for CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. For more detailed information on the credit offered for each session, please visit the registration page and click on the session of interest.

To register, please click here.

Join Us for a CLE Webinar on Strategies for Addressing Common, but Seldom Discussed, Mass Tort Litigation Irritants

As part of the Greater Philadelphia chapter of the Association of Corporate Counsel’s Litigation Law CLE Week, I am pleased to be joining my Reed Smith colleague Jim Beck and Endo Pharmaceuticals’ Vice President and Assistant General Counsel – Litigation and Risk Jobina Jones-McDonnell to present a 12 p.m. ET webinar tomorrow on “Out of the Shadows: Strategies for Addressing Common, But Seldom Discussed, Mass Tort Litigation Irritants.”

Discovery abuse abounds in mass tort litigation. We will be discussing aspects that often fly under the radar, including:

  • Expert depositions. These are routine in high-stakes litigation, but the process is disrupted by exorbitant fee demands by opposing experts, often exceeding $1,000 per hour. We will discuss how to resist and overcome such demands.
  • Third parties being targets of discovery abuse in complex litigation and receiving extravagant document subpoenas, compliance with which would disrupt their document retention policies. We will address how non-parties can quash or narrow such fishing expeditions.
  • Third Party Payor litigation, which also follows mass tort litigation as night follows day. We will discuss recent trends and developments.

CLE credit can be earned for PA, NJ and DE. The webinar is free for chapter members, is $25 for in-house counsel non-members, and is $225 for outside counsel non-members. To register, please visit this link, click the “register now” button, and select the “2020 Virtual Litigation Week” program.

Please join us for an upcoming CLE webinar, “Preparing for the inevitable: FCA investigations in a post-COVID world”

The CARES Act funding was a lifeline for many health care organizations and life sciences companies, but came with significant attached strings. Related fraud charges are already making headlines and bring with them the serious risk of False Claims Act litigation, which can have bet-the-company implications for companies.

Please join us this Wednesday, August 5 at 2 p.m. ET for a CLE webinar on “Preparing for the inevitable: FCA investigations in a post-COVID world” presented by our Life Sciences Health Industry Group partners Rick Robinson and Sarah Cummings.

This webinar will help companies understand the False Claims Act enforcement risks stemming from CARES Act funds, along with other enforcement risks stemming from COVID-related developments. Rick and Sarah will also provide an overview of recent key False Claims Act enforcement developments pre-COVID to set the stage for the discussion.

For more information, or to register, please click here.

This program is presumptively approved for 1.0 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia.  Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed.

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