In early 2025, the FDA quietly removed Theresa Michele, the longtime director of its Office of Over-the-Counter Drugs, just one day after her boss Richard Pazdur announced his retirement. This leadership shake-up has raised questions about how over-the-counter medicines will be regulated, what it means for drug makers, and whether consumers should expect changes to the safety and availability of common products like pain relievers, cough medicines, and allergy pills.


If you’ve ever grabbed an allergy pill at a pharmacy, picked up a cold medicine at a grocery store, or relied on a heartburn tablet from your bathroom cabinet, you’ve interacted—indirectly—with the FDA office now in the spotlight. Leadership changes at a regulatory agency can sound distant and political, but they can influence which products stay on shelves, what warnings appear on labels, and how quickly new over‑the‑counter (OTC) options reach the market.


FDA headquarters building in Washington, D.C.
The FDA’s headquarters in Washington, D.C., where key decisions about drug safety and availability are made. (Image credit: AP via STAT)

This overview breaks down what is known about the removal of Theresa Michele, why it matters that her supervisor Richard Pazdur is also stepping down, and how the transition could affect both the pharmaceutical industry and everyday consumers who rely on OTC medications.


What Happened at the FDA’s Over-the-Counter Drug Office?

According to reporting from STAT News, the Food and Drug Administration removed Theresa Michele from her position as director of the Office of Over-the-Counter Drugs on a Wednesday in February 2025. Six agency sources confirmed the move to STAT. The decision came just one day after Richard Pazdur—a highly influential FDA official overseeing cancer drugs and, more recently, other areas including OTC oversight—announced his retirement.


Michele had been a prominent figure in the OTC space for years, helping navigate complex transitions such as:

  • The modernization of the OTC monograph system, which governs thousands of nonprescription drugs.
  • High‑profile reviews of ingredients like decongestants and pain relievers.
  • Industry collaboration as companies sought to switch products from prescription to OTC status.

“Leadership stability at the FDA’s OTC office is especially important right now, given the agency’s ongoing work to modernize how nonprescription drugs are regulated,” said a regulatory affairs consultant familiar with the agency’s OTC reforms.


Why This Leadership Shake-Up Matters

On the surface, a change in who leads a regulatory office might seem like inside‑baseball bureaucracy. But because OTC drugs are used by millions of people daily, any shift in oversight can have ripple effects.


Over-the-counter medications displayed on a pharmacy shelf
Over‑the‑counter pain relievers, cold medicines, and allergy pills are regulated under specialized FDA frameworks.

The timing—coming immediately after Pazdur’s retirement announcement—raises practical questions for the near‑term direction of the OTC office:

  1. Continuity of ongoing projects: Regulatory reforms, ingredient safety reviews, and industry guidance documents may temporarily slow or shift in priority.
  2. Signal to industry: Companies in the OTC space are likely to watch closely for signs of how strict or flexible upcoming oversight might be.
  3. Consumer impact: While sudden changes on store shelves are unlikely, there could be medium‑term changes in what products are available and how they are labeled.


A Quick Primer: How the FDA Regulates Over-the-Counter Drugs

Understanding the significance of this leadership change is easier if you know how OTC drugs are regulated. Unlike dietary supplements, which follow a different legal framework, OTC drugs must generally meet standards of safety, effectiveness, and quality before they can be sold without a prescription.


The FDA uses two main pathways for OTC drugs:

  • OTC monographs: These are “rulebooks” that cover many common ingredients, doses, and indications (for example, certain antihistamines or pain relievers). If a product complies with an existing monograph, it can often be marketed without individual product approval.
  • New Drug Applications (NDAs) and switches: Some products start as prescription drugs and later “switch” to OTC status after additional data show they can be used safely without a prescriber’s supervision.

“The OTC drug monograph reform was one of the most significant updates to nonprescription regulation in decades,” noted an academic expert in pharmaceutical policy. “Strong leadership is key to implementing it effectively.”

Regulatory documents and a laptop on a desk
Regulatory officials rely on scientific data, public comments, and statutory frameworks to oversee OTC drug safety and labeling.

Potential Impact on Drug Manufacturers and Retailers

For companies that make or sell OTC medicines, leadership changes can influence timelines, compliance strategies, and investment decisions. While the full implications of Michele’s removal are not yet public, some foreseeable areas of impact include:


  • Regulatory predictability: Industry often looks for consistent, transparent expectations. A period of transition could mean more uncertainty about how quickly products are reviewed or how strictly certain rules are interpreted.
  • OTC monograph reform rollout: Ongoing implementation details—such as how swiftly the FDA updates monographs based on new evidence—may be revisited or reprioritized under new leadership.
  • Innovation and Rx‑to‑OTC switches: Companies considering switching drugs from prescription to OTC may reassess timelines or strategies while they watch how the new leadership approaches benefit‑risk assessments.
  • Enforcement focus: Shifts in leadership can sometimes be accompanied by changes in enforcement priorities, such as labeling compliance, marketing claims, or manufacturing quality issues.


What Does This Mean for Consumers Right Now?

For everyday consumers, the immediate impact of Michele’s removal is likely to be subtle rather than dramatic. You should not expect overnight disappearance of major OTC products from shelves just because of a leadership change. Decisions to remove or restrict specific drugs generally follow evidence‑based safety reviews, advisory committee input, and public announcements.


Person reading a medicine label carefully at home
Reading labels carefully and following dosing instructions remains essential, regardless of who leads the FDA’s OTC office.

In the short term, the safest and most practical steps for consumers remain the same:

  • Read and follow the Drug Facts label on every OTC product.
  • Avoid doubling up on medicines with similar active ingredients (for example, multiple acetaminophen‑containing products).
  • Consult a healthcare professional if you have chronic conditions, take multiple medications, or are unsure what’s appropriate.
  • Monitor FDA safety alerts through FDA Drug Safety and Availability.

“Leadership transitions at FDA should not change the basic precautions consumers need to take with over‑the‑counter medicines,” said a primary care physician. “Dose carefully, read labels, and ask for help when you’re unsure.”

Evidence, Oversight, and Checks on FDA Leadership

Even when leadership changes, the FDA operates within a web of legal, scientific, and public‑accountability structures. This limits the extent to which any single official, whether it’s a director or a retiring supervisor like Pazdur, can unilaterally reshape policy.


Key safeguards include:

  • Statutory requirements: Federal law defines what standards OTC drugs must meet, and these laws do not change simply because personnel do.
  • Advisory committees: Independent expert panels often review evidence on contentious issues like ingredient safety or new OTC switches.
  • Public comment and transparency: Many regulatory changes involve public dockets and opportunities for comment, creating a record that can be scrutinized.
  • Judicial and congressional oversight: Courts, the Government Accountability Office, and Congress can all review or question agency actions.


Leadership transitions often create a sense of uncertainty—whether you’re a policy‑watching citizen, a health professional, or part of the pharmaceutical supply chain. While details about Michele’s removal remain limited, there are concrete, measured steps each group can take.


For consumers

  • Stick to reputable brands and retailers.
  • Check expiration dates and discard outdated products safely.
  • Report any serious side effects to the FDA MedWatch program.

For healthcare professionals

  • Stay updated on FDA safety alerts that might affect commonly recommended OTC products.
  • Educate patients about safe self‑medication and label reading.
  • Encourage patients to disclose all OTC products and supplements they use.

For industry and regulatory teams

  • Review all ongoing submissions and plan for potential timeline variability.
  • Monitor FDA speeches, stakeholder meetings, and updated guidance from CDER.
  • Engage early and often with FDA when seeking complex Rx‑to‑OTC switches or novel indications.

Stakeholders across healthcare and industry often coordinate responses to regulatory changes and leadership transitions.

Looking Ahead: What to Watch After Michele’s Removal and Pazdur’s Retirement

The most important developments are likely to unfold over the coming months as the FDA clarifies who will lead the OTC office on an interim and long‑term basis, and how responsibilities once overseen by Richard Pazdur are redistributed. Watch for:


  • Official FDA announcements about new or acting leadership for the Office of Over-the-Counter Drugs.
  • Changes in the pace of OTC ingredient reviews and new OTC switches.
  • Any high‑profile advisory committee meetings on widely used OTC ingredients.
  • Updated guidance documents that may signal evolving priorities in enforcement or innovation.

Until more details emerge, the best approach is cautious attention rather than alarm. Regulatory systems are designed to outlast any single leader.


Conclusion: Stay Informed, Not Alarmed

The removal of Theresa Michele from her role as director of the FDA’s Office of Over-the-Counter Drugs, coming just after Richard Pazdur’s retirement announcement, marks a notable moment for U.S. drug regulation. Yet for most consumers, the everyday guidance remains unchanged: use OTC medicines thoughtfully, follow labels carefully, and turn to trusted healthcare professionals and official FDA channels when you have questions.


For industry and policy watchers, the coming months will clarify whether this leadership turnover signals a new direction for OTC oversight or a reorganization without major shifts in policy. Paying attention to official FDA announcements, advisory committee meetings, and updates to OTC monographs will provide a clearer, evidence‑based picture than speculation alone.


If you rely on OTC medicines—like most households do—consider this an opportunity to:

  • Re‑read the labels in your medicine cabinet.
  • Discard anything expired or unclear.
  • Bookmark the FDA’s drug safety page for future reference.

Regulatory leadership will continue to change over time, but the core goal of ensuring that widely used medicines are safe, effective, and clearly labeled remains constant. Staying informed, asking questions, and practicing careful self‑care are still the most practical ways to protect yourself and your family.