Co-Chairs’ Opening Remarks

Torrey Cope
Partner
Sidley Austin LLP
(Washington, DC)

Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C. (Washington, DC)

Exploring New FDA Initiatives

Torrey Cope
Partner
Sidley Austin LLP
(Washington, DC)

Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C. (Washington, DC)

This panel will discuss recent changes made to the law by the FDA User Fee Reauthorization Act of 2022, and the Food and Drug Omnibus Reform Act of 2022, including with respect to clinical trials and accelerated approval. In addition, the panel will highlight recent litigation against FDA and pending legislation of significance.

THE PRE-APPROVAL AND APPROVAL PROCESS

Navigating the Approval Process for Drugs and Biologics

James William Woodlee
Partner
Kleinfeld, Kaplan & Becker, LLP (Washington, DC)

Innovator Products: New Drug Applications and Biologic License Applications

The Drug Review Process

• Reviewing the fundamentals of applications; from submission, through filing and beyond
• Making sense of PDUFA Goals, fast track, break through status, and other process enhancements
• Use of administrative appeals

Rx Drugs (Small Molecules)

• Understanding the difference between “new drugs” and other drugs
• Examining the research, development, and approval process for new drugs
• Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)

Biological Products (Large Molecules)

• What are biological products in relation to traditional drugs?
• Deciphering the biologics license application (BLA)
• How do the research, development, and approval process for biological products differ from the process for new drugs?
• Exploring key similarities and differences between the drug and biological product schemes

NDAs and BLAs

• Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs
• Identifying applications for fixed-dose combination drugs
• Distinguishing complex molecules regulated through NDAs from from small molecules
• Examining standards for approvals
• REMS

OTC Products

• Understanding the concept of “OTC” (OTC-ness)
• Examining the OTC Review and monographs
• Differences between approved and monographed OTC drug products
• OTC Monograph Drug User Fee Program (OMUFA)
• Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements

Morning Break

Exploring FDA’s Expedited Programs: Applicability and Eligibility

Benjamin Zegarelli
Of Counsel
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
(New York, NY)

Distinguishing among the different FDA programs for expedited review and approval of drug products

• Evaluating the criteria for eligibility, benefits, and limitations of each program
• Understanding accelerated approval, surrogate and intermediate clinical endpoints
• Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs
• Reviewing priority review
• Factoring expedited programs into your drug development strategy
• Discuss recent changes to FDA’s Accelerated Approval program

Expedited Approval Case Study: Chasing the COVID-19 Vaccine

This case study will focus on the expedited approval process and other related health submissions to further access a COVID-10 vaccine for Americans. Experts will also identify any legislation that is being used to support the approval process.

Lunch Break

Appreciating the Nuances of the Approval Process for Controlled Substances

Delia Deschaine
FDA/DEA Regulatory Attorney - Member of the Firm (Partner)
Epstein Becker & Green PC
(Washington, DC)

• Defining the term “controlled substance”
• Reviewing the scheduling process before (and after) FDA-approval by HHS and DEA
• Discussing the proper steps for companies who incorporate substances with abuse potential into their products
• Understanding what clinical (and pre-clinical) evidence is relevant or necessary to present to the proper agencies
• Exploring state regulations that apply when working with controlled substances
• Implementing the manufacturing quotas that exist for these products
• Marijuana and psychedelic medicine considerations

Clarifying the Clinical Trial Process for Drugs and Biologics

Maureen Bennett
Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice
Jones Day LLP (Boston, MA)

• Overview of clinical trials and how they are used (including different phases)
• Identifying the different parties involved (sponsors, investigators, CROs, etc.)
• Understanding human research protection (ICF, IRB)
• Enforcement
• Review of the “Right to Try” laws and their requirements during the clinical trials process

Afternoon Break

IP Overview for Drugs and Biologics

Part 1 – Patents and Related IP Protections and Mechanisms

Alissa Lipton
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Patent Protection for Drugs and Biologics

• Summarizing the patenting process for drugs and biologics
• Strategies for building patent protection for drugs and biologics
• Applying for and achieving extension of patent term for time spent in the drug approval process
• Patent Term Extension (“PTE”)
• Patent Term Adjustment (“PTA”)
• Reviewing the 271(e)(1) “safe harbor” provision
• Distinguishing the patenting process for drugs from that of biologics
• Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products

IP Overview for Drugs and Biologics

Part 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

Eric T. Romeo
Partner
Goodwin Procter LLP

Drugs

• Overview of Hatch-Waxman and reforms
• 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
• Reviewing fundamentals of applications
• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
• Special considerations: local acting drugs, labeling carve outs and other nuances
• Understanding the role of the Orange Book in the drug approval process
• listings, de-listings and use codes
• Market exclusivities and protection
• Identifying the different types of exclusivities
• Regulatory exclusivity (FDA)/ (data) exclusivity
• NCE (new chemical entity)
• 5 years data exclusivity
• indication (new indication or use)
• 3 years marketing exclusivity
• NDF (new dosage formulation)
• ODE (orphan drug exclusivity)
• PED (pediatric exclusivity)

Biologics

• Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Understanding the rationale for safety and efficacy concerns surrounding second generation biologics
• Exploring the concepts of “biosimilarity” or “interchangeability”
• FDA rule-making and guidance relative to biosimilars
• Other points for consideration: substitution, naming, patents, and additional nuances
• Examining biosimilar exclusivities
• “Shall we dance” — weighing the pros and cons of participating in the patent dance
• Deciding when to provide notice of commercial marketing

Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process

Maya P. Florence
Partner
Skadden, Arps, Alate, Meagher & Flom LLP (Boston, MA)

The labeling of the drug/biologic is the final stage of the approval process. The label controls what you can do post-approval and as such it is the point of transition between the approval process and post-approval world.

• Labeling overview: key regulatory requirements, information, and contents
• Exploring the review process for labeling
• Incorporating clinical trial data on the label
• Appreciating the influence of final labeling on the scope of post-market activities
• Amending labeling post-marketing
• Using labeling as a defense in products liability litigation
• Exploring label carve outs
• Discussing the requirements for skinny and narrow labeling

Conference Adjourns to Day Two

Co-Chairs’ Remarks and Recap of Day One

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process

Seth A. Mailhot
Partner
Husch Blackwell LLP
(Washington, DC)

• Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization
• Factoring cGMPs into the scope of the FDA’s authority
• Exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs
• Conducting laboratory investigations in relation to cGMPs
• Understanding the influence of cGMPs in products liability litigation
• Evaluating the costs and impact of enforcement actions

Advertising, Promotions, and Related First Amendment Concerns:
Part 1 – Drug and Biologics Advertising and Promotion 101

Marc J. Scheineson, Esq.
Partner
Alston & Bird LLP (Washington, D.C.)

• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
• 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA
• Guidance documents
• Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications)
• What duties and responsibilities is DDMAC charged with?
• What are its enforcement capabilities and jurisdiction?
• Identifying the role of the FTC in the advertising and promotion of drugs
• SEC?
• Advertising requirements for prescription v. nonprescription products
• Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
• Overview of the promotional materials submission and review process
• What constitutes a launch?
• What defines an advertisement?
• What information must a drug advertisement include?
• Exploring the role of the label in advertising

Morning Break

Advertising, Promotions, and Related First Amendment Concerns:
Part 2 Exploring the Subtleties and Safe Zones of Off-Label Communications

Joel Kurtzberg
Partner
Cahill Gordon and Reindel LLP (New York, NY)

• Clarifying FDA’s current position on First Amendment and off-label promotion
• The 21st Century Cures Act
• FDAMA 114
• What to expect concerning proposed legislation, rules changes and Citizen Petitions
• Cases and controversies: state AG actions and private tort claims

Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

Beth Weinman
Counsel
Ropes & Gray LLP (Washington, DC)

• What is pharmacovigilance?
• How pharmacovigilance uses adverse event reports
• Direct versus indirect reports
• Causality assessments
• Labeling changes
• Pre-and post-market ADE reporting requirements
• How regulatory agencies use ADE reports
• Exploring protocols for Risk Evaluation and Minimization Strategies (REMS)
• Understanding the role of risk evaluation in the approval process
• Identifying risk minimization tools
• Enforcing ADE reporting and REMS requirements
• Examining the relevance to product liability risks, including innovator and co-promoter liability risks
• What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)?
• Guidance versus regulation
• Voluntary recalls versus mandatory recalls
• Market withdrawals and stock recoveries
• Interaction between recalls and corrective and preventive action

Understanding the Scope of FDA Enforcement Authority and Actions

Hannah Bornstein
Partner
Nixon Peabody LLP

• Enforcement overview—identifying the players and their positions
• Investigations, enforcement, litigation, and defenses
• Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions
• Exploring FDA compliance and enforcement mechanisms
• Inspections
• For cause inspections vs. routine inspections
• Communication with the FDA during inspections
• EIRs
• Form FDA 483 observations
• Untitled and Warning Letters
• Related to inspections
• Resulting from non-inspection data or information
• Examining enforcement actions related to digital advertising and social media

Main Conference Ends