GLP-1 Law & Policy

The GLP-1 boom has led to rapid re-evaluation by the federal and state governments. Market pressures, industry particularities, and the unique nature of GLP1s are impacting the legislative tilt, but the dust has yet to settle. Identifying the contours of regulation are fundamental to ensuring long-term success and security.

Topics of discussion will include

• Analyzing pending state and federal legislation regarding GLP-1 marketing, manufacturing, and more
  • Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025/2026 (H.R. 6509/S. 3794)
  • GAP Supply Act (H.R. 7528)
  • Drug Shortage Compounding Patient Access Act of 2025 (H.R.5316)
  • Most-Favored-Nation Prescription Drug Pricing Executive Order
• Responding to regulatory enforcement efforts from FDA
• Detangling competing pressures and their sway on governmental regulators
• Breaking down the potential consequences of pending legislation before it passes
• Assessing the implications of shifting Medicare timelines, state AG activity, and the FDA posture following their February 6 letter
• Surveying IRA/CMS Medicare negotiation mechanics and contracting implications
• Preparing for pending and potential legislation before the ball drops

The GLP-1 market is on track to hit $33.26 billion by 2030, and innovators and compounders alike have taken notice. Post-shortage, some GLP-1 providers are searching for new ways to meet this demand. But the cutting edge comes with uncertainty, questions, and potential pitfalls.

Topics of discussion include:

• Surveying post-shortage 503A/503B ingredient sourcing and enforcement
• Understanding national and global guidelines for the research and development of new peptides
• Assessing restrictions on the who, what, when, where, and why of peptide development
• Analyzing state-by-state regulation of peptides
• Determining how “wellness” and MedSpas are interacting with the existing GLP-1 market

Intellectual property sits at the core of investment in the research and development of novel drugs. Though patents are central to IP protection, until recently copyright and trademark disputes have dominated the GLP-1 litigation landscape. As patent litigation kicks off, and semaglutide nears the end of its patent exclusivity term, understanding the baseline of GLP-1 IP protections and threats is critical to ensuring a competitive edge in the market.

Topics of discussion include:

• Examining the current swath of existing patents in the GLP-1 space
• Assessing the rush for new patent filings over the last year
• Identifying the copyright, trademark, and unfair competition assertions brought to trial
• Predicting the impact of generics on GLP-1 market activity
• Understanding IP from the perspective of market control

The future of the GLP-1 landscape is still in question, but one thing is clear: demand will not slow down. This session will bring together participants from all sides of the industry, from innovators to compounders to market players, to discuss how to facilitate and prioritize strategic, mutually beneficial partnerships and ensure long-term success.

GLP-1s are everywhere, and everyone wants a piece. As a result, patient protection varies widely from prescriber to prescriber, and manufacturer to manufacturer. Add on the competitive drive to corner the market, and it’s important to ask, “when does market protection run in opposition to the best interest of the patient?” This session will break down the ways to protect your product while ensuring patient safety and satisfaction across GLP-1 applications.

Market Health

• Understanding the tension between investment, access, and market demand
  • Venture capital trends
• Investigating development and manufacturing supply chains
• Interacting with regulatory bodies from legislators to state licensing boards

Patient Safety

• Discussing the different sources of GLP1s and their implications on consumer choice, market health, and patient safety
  • Traditional prescriptions
  • Telehealth providers
  • Peptide sellers
  • Other gray market sources
• Describing the different online consumer marketing and prescribing workflows with Telehealth providers and what factors relate to patient safety concerns
• Assessing current guidelines for patient follow-up and prescription timelines
  • Telehealth vs. in-office doctors’ visits
  • Self-diagnosis
  • Self-administration
• Considering where compounded drugs should fit into the patient access conversation
• Discerning between clinical and cosmetic applications of GLP-1s
  • Efficacy
  • Impact
  • Demand
  • Side effects
• Responding to patient advocacy
  • Policy development
• Distinguishing between actions taken to protect the patient vs. actions taken to protect the market
• Pondering whose responsibility it is to ensure patient protection
  • Drug safety and efficacy
  • Informed consent
  • Yet-to-be-seen side effects

Despite rapid growth and fervent demand for GLP-1s, long-term effects of the drugs remain to be seen. Moreover, compounded drugs are not subject to the same rigorous clinical testing as their FDA-approved counterparts. Taking proactive steps now to prepare for future litigation, mass torts, and potential class action threats is necessary to protect your company and clients in the long-run.

Topics of discussion will include:

• Monitoring, assessing, and ensuring adequate pharmacovigilance across GLP-1 drugs and manufacturing
• Flagging and remedying serious adverse effects associated with GLP-1s before facing suit
• Anticipating and preparing for MDLs and class actions
• Preempting issues caused by GLP-1 usage

From television to TikTok, from busses to subways, from podcasts to newspapers, it is impossible to escape GLP-1 advertisements in 2026. Increased focus on advertising claims, spokesperson scrutiny, and bad press, however, mean rigorous control over GLP-1 advertising is more critical than ever.

Expanding on and going beyond the discussion of copyright, trademark, and unfair competition, topics of discussion for this session will include:

• Identifying advertising threats and potential PR pitfalls
  • How does “going viral” impact the market?
  • Is there such a thing as bad press?
• Considering the role of spokespeople, influencers, and partnerships
• Assessing the divide between marketers’ ad claims and ad law principles for health claims
• Reacting to the FDA’s Feb. 6 letter addressing the mass-marketing of non-FDA approved drugs
• Breaking down how EU advertising limitation differ from those in the US, and what that means for patient knowledge, access, and demand
• Understanding the impact of weight loss advertisements on children and young adults
  • Access to the drug
  • Prescriber limitations

GLP-1 demand continues to increase as new delivery methods, access pathways, and weight-loss products emerge. With the blockbuster drug on pace to make tens of billions, we’re still only at the beginning. This session will consider the market as it exists today, and ponder what to expect for GLP-1 legislation, regulation, and litigation over the next 6 months, one year, five years, and beyond.