A Look Ahead In Life Sciences: What We Are Tracking In Q1 2023 And Beyond – Life Sciences, Biotechnology & Nanotechnology

As the life sciences industry continues to expand and grow
increasingly complex, so does its legal regulatory, and compliance
landscape. To help companies and investors navigate the many
evolving and emerging laws and regulations across pharmaceuticals,
biologics, drug development, medical devices and technology, and
diagnostics, our Life Sciences Regulatory team has provided a
comprehensive list of developments. We will update this list on an
ongoing basis throughout the year.

WHAT WE ARE TRACKING

Preclinical & Clinical Research

How companies develop their products:

FDA Approval

Deciding whether a company can market or sell a specific
product:

Pharmaceuticals/Biologics

• We will continue to see the use of real-world evidence
  in submissions, including likely continued guidance from FDA.
  Section 3629 of the [omnibus law] requires FDA to issue and/or
  update its guidance within one year. (US)

Medical Device/Medtech

In Vitro Diagnostic/Laboratory Testing

• We expect forthcoming guidance
  from FDA on medical devices that fall within enforcement policies
  and Emergency Use Authorizations (EUAs) issued during the COVID-19
  Public Health Emergency. (US)




• Note: The Omnibus Spending Law did not include
  the VALID Act, covering FDA regulation of laboratory developed
  tests (LDTs). (US)

Notable Regulatory Approval Updates Outside the United
States

• We highlight the January 2023 formal proposed
  regulation issued by the European Parliament and Council
  extending the Medical Device Regulation implementation period,
  slated for acceptance in early 2023. (EU)




• We expect to see and plan to follow an early 2023 EU pilot program
  implementation for expert panel assistance to orphan and
  breakthrough device manufacturers. (EU)

Commercial FDA Requirements

How companies manufacture, promote, and monitor their
approved products:

• FDA’s quality
  management system regulations with ISO 13485. (US)




• We will see FDA implement its newly expanded authority
  under section 2511 of the Omnibus Spending Law for registration of
  foreign manufacturers contributing to products, such as those
  performing processing steps, producing ingredients or components,
  to register with the FDA. (US)




• Section 3611 of the Omnibus Spending Law expands FDA’s
  authority over medical device inspections to allow the FDA to
  collect “records or other information” from facilities
  “in advance of, or in lieu of” inspections of
  manufacturing establishments. We will be monitoring for FDA’s
  guidance on this new authority. (US)

Coverage & Reimbursement

Whether Medicare/Medicaid or commercial payors are
willing to pay for a product, how much, and under what
circumstances:

• Section 3630 of the
  Omnibus Spending Law codifies FDA’s previous guidance that
  permits pre-approval communication to payors and formulary
  committees about healthcare economics information related to
  unapproved products or unapproved uses of products. (US)

Pharmaceuticals/Biologics

• We continue to follow how the Inflation Reduction
  Act of 2022 will impact reimbursement for pharma & biologic
  products (price caps, required discount program for all drugs,
  mandatory rebates if a drug’s price increases at a rate that
  outpaces inflation, and a redesign of the Medicare Part D benefit).
  We anticipate program instructions from CMS with respect to price
  caps for expensive single-source drugs and biologics in 2023. Some
  companies (for example, Eli Lilly) have already announced making
  pipeline changes based on the IRA’s effects. (US)




• HHS has issued a new proposed rule
  that would modify the current alternative dispute resolution
  process under the 340B drug discount program, which has been the
  subject of much scrutiny and disagreement among pharmaceutical
  manufacturers (who are obligated to cap prices significantly for
  patients of qualified covered 340B public health entities) and the
  public health entities whose patients benefit from reduced 340B
  pricing. The proposed rule (which is open for comments until Jan.
  30, 2023) would simplify and expedite the process by which covered
  entities and drug manufacturers resolve disputes about
  overcharging, duplicate discounts, or drug diversion. (US)

Medical Device/Medtech

Compliance, Fraud & Abuse, Transparency

Companies’ interactions with their customers and
other stakeholders:

• Shifts in DOJ Compliance
  Guidance and priorities – Compensation, Mobile Devices,
  Role of the Chief Compliance Officer – continue to be front
  of mind for our chief compliance officer clients. (US)




• We are seeing continued increase in DOJ enforcement of the
  False Claims Act and Anti-Kickback Statute in laboratory,
  diagnostic testing, and telehealth spaces. (US)

Patient Privacy

Companies’ interactions with sensitive patient
data:

*On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the
“Omnibus Spending Law”). We have highlighted below
several notable provisions from the Omnibus Spending Law, including
provisions derived from the Food & Drug Omnibus Reform Act
(FDORA) and the Pre-Approval Information Exchange Act (PIE)
Act.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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