Header graphic for print

Focus on Regulation

FDA guidance may ease path to biosimilar interchangeability

On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product.  Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of obtaining a determination of interchangeability.  The guidance summarizes the important scientific considerations for demonstrating interchangeability, including: Continue Reading

FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for Continued Marketing

On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including sunscreens.  As FDA has previously explained, the guidance states that MUsT studies can identify the potential for the systemic exposure for a topically-applied active ingredient.  FDA believes that this information is necessary to determine whether additional safety studies are needed to support a finding that the ingredient is generally recognized as safe and effective (GRASE) for its intended use.

FDA’s reliance on MUsT studies has been a subject of controversy with the sunscreens industry.  Industry has argued that MUsT studies are unreasonably expensive and sunscreen products have been marketed in the U.S. and around the world for decades without adverse events or data identifying safety concerns related to absorption.  To support an OTC drug monograph, FDA has said that a MUsT study should evaluate the ingredient in a range of formulations, which further adds to the cost and time needed for such a study.

FDA: Absorption Is Not Just a Theoretical Concern

However, just a few days before the issuance of the MUsT guidance, on May 6, 2019, FDA released a statement reaffirming the agency’s reliance on MUsT studies for evaluating sunscreens.  The FDA statement highlights an FDA-funded study published on the same day in the Journal of the American Medical Association (JAMA), evaluating the absorption of four sunscreen ingredients Continue Reading

New Ethics Guidelines for Trustworthy Artificial Intelligence

On 8 April 2019, the European Commission’s High-Level Expert Group on AI (“HLEG AI“) published its ethics guidelines for trustworthy artificial intelligence (the “Guidelines“). The Guidelines follow an earlier first draft in December 2018 and implement more than 500 comments received through an open consultation. The Guidelines aim to provide a framework for achieving “Trustworthy AI”: artificial intelligence that is (i) lawful, (ii) ethical, and (iii) robust. In particular, the Guidelines focus on offering guidance on fostering and securing ethical and robust AI. Continue Reading

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance.  The final guidance contains no significant substantive changes to the draft version, but here are a few interesting tidbits:

  • FDA will respond to comments seeking clarification on the process for obtaining therapeutic equivalence evaluations in a forthcoming guidance document.
  • FDA clarified that petitioned ANDAs are expected to have the same therapeutic effect as the reference listed drug.
  • Revisions to the discussion about what kind of information may be submitted in an ANDA seem to emphasize FDA’s “significant flexibility” on this issue.

As always, the devil is in the details.  Much policy will be developed in the context of individual applications.  For more information on how to strategically approach drug approval pathways (yours or a competitor’s), please contact any of the authors of this alert or the Hogan Lovells lawyer with whom you regularly work.

Individuals as Whistleblowers

Cartels are by their nature hard to uncover and regulators rely – to a large part – on appealing to companies’ wallets. Immunity and leniency policies, by which regulators offer to whistleblowing companies full immunity or discounts from fines, have been around for a long time. An increasing number of regulators have now added another instrument to their cartel enforcement toolkit: the offering of financial incentives to lure individual employees to come forward and whistleblow against their employers or former employers. By way of example, the Hungarian Competition Council provides a reward calculated as a percentage of the cartel fine imposed, with a maximum limit of HUF 50,000,000 (approximately EUR 155,000 or USD 175,000). Similarly, the Taiwan Fair Trade Commission also offers a financial reward of potentially up to 20% of the amount of fines that it recovers. The Korean Fair Trade Commission is reported to generously offer up to KRW 3 billion (approximately EUR 2.2 million or USD 2.5 million).

Financial rewards, however, can only go so far in encouraging individuals to come forward and some regulators have recognised the importance of countering the strong disincentives of whistleblowing on the individual, including distress and loss of career prospects, by offering other means of support, such as the promise of anonymity. Continue Reading

NIST Seeking Input on AI Technical Standards by May 31, 2019

On May 1, 2019, the National institute of Standards and Technology (NIST) announced a Request for Information (RFI) in the Federal Register regarding ongoing efforts to develop technical standards for artificial intelligence (AI) technologies and the identification of priority areas for federal involvement in AI standards-related activities. Responses to the RFI are due by May 31, 2019.

The RFI comes in response to President Trump’s Executive Order to Maintain American Leadership in Artificial Intelligence, which among other actions directs NIST to develop a plan to guide the federal government’s engagement with initiatives to develop technical standards for AI technology. This RFI, along with others released by this Administration, reflect a desire to promote AI technologies that enhance America’s interests and strengthen the public’s trust and confidence in AI. Continue Reading

The Canadian Ombudsperson for Responsible Enterprise – Lingering Questions on the Role’s Mandate and Powers

Earlier this month, the Canadian government announced the appointment of Sheri Meyerhoffer as the first Canadian Ombudsperson for Responsible Enterprise (“CORE”). The position has been lauded as being the first of its kind in the world. This blog post considers a number of the key issues which are still to be ironed out before Ombudsperson Meyerhoffer begins her work in earnest. Continue Reading

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary recall.  Overall, FDA emphasizes the importance of pharmaceutical, biotechnology, medical device, food, tobacco, and animal products firms having made plans in advance of a recall so that they are prepared, should one become necessary.

How to be “Recall Ready”

In order to facilitate timely initiation of a voluntary recall, the draft guidance recommends firms make the following preparations: Continue Reading

Equator Principles – Sustainable Infrastructure Projects for Future Generations

The construction and further development of infrastructure is of crucial importance for society and a healthy economy. But protecting the environment and human rights has also come to the forefront of the global agenda. At times these two goals have been cast as mutually exclusive, but the financing community has recognized the imperative to harmonize developing modern infrastructure with preserving our natural habitat and upholding social standards.

The majority of financing banks have for some time attempted to ensure the sustainability of infrastructure projects by following the Equator Principles (EPs), which establish certain environmental and social standards.

In order to extend the scope of the EPs, set higher environmental and social standards and to align the EPs with other international guiding principles such as the United Nations Guiding Principles on Business and Human Rights (UNGPs), the EPs are continuously evolving. Since the release of the fourth version of the EPs (EP IV) is approaching, this article will not only present the current status, but also give a preview of expected developments in light of criticism levied at the current version of the EPs. Continue Reading

Vedanta: UK Supreme Court takes the “straitjacket” off claims against parent companies in the English Courts

On 10 April 2019, the UK Supreme Court handed down its judgment in Vedanta Resources PLC and anor. v Lungowe and others [2019] UKSC 20; a long awaited decision on parent company liability and the jurisdiction of English courts over transnational torts. This blog sets out the key findings and practical implications of the judgment, with a particular focus on what it means for human rights related claims against multinationals and the policies and procedures which they adopt to address the risk of adverse human rights impacts associated with their overseas subsidiaries and supply chains. Continue Reading