FDA chief Marty Makary says ‘everything should be over-the-counter’ unless drug is unsafe or addictive

FDA chief Marty Makary says ‘everything should be over-the-counter’ unless drug is unsafe or addictive

FDA chief Marty Makary has stated that, in his view, all drugs should be available over-the-counter (OTC) unless they are demonstrably unsafe or addictive. Makary indicated that the FDA is actively reviewing prescription drugs, including specific categories like nausea medications and vaginal estrogen, with the aim of reclassifying some to OTC status within the current year. This statement signals a potential shift in the agency's regulatory approach to drug accessibility.

Context & What Changed

The statement by FDA chief Marty Makary represents a significant potential shift in the regulatory philosophy governing drug accessibility in the United States. Traditionally, the U.S. Food and Drug Administration (FDA) operates on a two-tiered system for drug classification: prescription (Rx) and over-the-counter (OTC). Prescription drugs require a healthcare professional's authorization due to factors such as potential for misuse, complexity of diagnosis, need for professional monitoring, or significant side effects. OTC drugs, conversely, are deemed safe and effective for use by the general public without a prescription, provided they are appropriately labeled and used as directed (source: fda.gov).

This established framework prioritizes patient safety through professional oversight, aiming to prevent misdiagnosis, inappropriate drug use, and adverse drug reactions. The process for switching a drug from prescription to OTC status is rigorous, requiring manufacturers to demonstrate that the drug can be safely and effectively used by consumers without the guidance of a healthcare provider. This involves extensive data on consumer understanding of labeling, self-selection accuracy, and the drug's safety profile in a non-supervised setting (source: fda.gov).

Makary's assertion that 'everything should be over-the-counter' unless proven unsafe or addictive fundamentally challenges this long-standing paradigm. It implies a reversal of the default assumption, shifting the burden of proof from demonstrating OTC safety to demonstrating prescription necessity. This perspective, if adopted as agency policy, would represent a proactive and potentially expansive approach to deregulation within the pharmaceutical sector. The mention of specific drug classes like nausea medications and vaginal estrogen, along with a timeline for potential changes 'this year,' indicates a concrete intent to initiate this shift rather than merely a theoretical discussion (source: cnbc.com).

This proposed change is set against a backdrop of increasing healthcare costs, a desire for greater consumer empowerment, and advancements in digital health literacy. Proponents of greater OTC access often cite potential benefits such as reduced healthcare expenditures, improved access to care, and increased convenience for patients managing common conditions. However, critics and cautious observers highlight the inherent risks associated with reduced professional oversight, including potential for misdiagnosis, delayed treatment for serious conditions, inappropriate drug use, and drug interactions.

Stakeholders

The potential policy shift articulated by FDA chief Makary would have profound and varied impacts across a wide array of stakeholders:

1. U.S. Food and Drug Administration (FDA): The primary regulatory body. A shift would necessitate a re-evaluation of its drug classification processes, potentially requiring new guidelines, increased resources for post-market surveillance of newly OTC drugs, and a significant public education mandate. The agency would face pressure from both industry for faster switches and public health advocates for stringent safety standards.

2. Pharmaceutical Companies:

Innovator Drug Manufacturers: Companies holding patents on prescription drugs would need to assess the strategic implications of potential OTC switches. While an OTC switch can extend a drug's lifecycle and broaden its market, it often comes with lower pricing power and increased competition from generics. R&D pipelines might shift towards developing drugs with OTC potential or focus on more complex, high-value prescription therapies.

Generic Drug Manufacturers: These companies could see new opportunities as more drugs become eligible for generic OTC versions, potentially expanding their market share and product portfolios.

Consumer Healthcare/OTC Divisions: These divisions would likely experience significant growth opportunities, requiring increased investment in marketing, consumer education, and supply chain management.

3. Healthcare Providers:

Physicians and Specialists: May see a reduction in patient visits for minor ailments, allowing them to focus on more complex or chronic conditions. However, they might also face challenges related to patients self-diagnosing or mismanaging conditions with OTC drugs, potentially leading to more advanced or complicated cases.

Pharmacists: Their role would likely expand significantly. As the most accessible healthcare professionals, pharmacists could become crucial gatekeepers and educators for newly OTC drugs, providing guidance on appropriate use, potential interactions, and when to seek physician care. This could necessitate changes in pharmacy scope of practice and reimbursement models.

4. Patients and Consumers: Would benefit from increased access, convenience, and potentially lower costs for managing common health issues. However, they would also bear greater responsibility for self-diagnosis, understanding drug labels, and recognizing when professional medical attention is required. This shift could disproportionately affect vulnerable populations with lower health literacy or limited access to reliable health information.

5. Public Health Organizations: Groups focused on public health and safety would likely advocate for robust consumer education campaigns, clear labeling requirements, and continued post-market surveillance to monitor the impact of increased OTC access on population health outcomes.

6. Health Insurance Companies: Could see a reduction in claims for physician visits and prescription drug costs for conditions that can be managed with OTC products. However, they might also need to adapt coverage models for pharmacist consultations or new OTC categories, and potentially manage increased costs from adverse events due if self-medication leads to complications.

7. Government Health Agencies (e.g., CMS, State Health Departments): Would need to monitor the broader public health impact, assess changes in healthcare utilization patterns, and potentially adjust public health campaigns and educational initiatives.

Evidence & Data

The current U.S. pharmaceutical market is substantial, with prescription drugs accounting for the vast majority of spending. In 2022, total U.S. prescription drug spending was estimated at approximately $378 billion (source: cms.gov, author's assumption based on publicly available data). The OTC market, while significant, is considerably smaller, estimated at around $35-40 billion annually (source: chpa.org, author's assumption). This disparity highlights the immense potential for market reallocation if a substantial number of prescription drugs were to switch to OTC status.

Historical data demonstrates a consistent trend of prescription-to-OTC switches over decades. Notable examples include ibuprofen, naproxen, omeprazole, loratadine, and various topical corticosteroids. These switches have generally been successful, expanding patient access and reducing healthcare costs for common conditions without a significant increase in adverse events, largely due to stringent FDA review processes and clear labeling (source: fda.gov).

For instance, the switch of proton pump inhibitors (PPIs) like omeprazole (Prilosec OTC) allowed millions of individuals to self-manage frequent heartburn, reducing the need for doctor visits. Studies on these switches often show that while some consumers may misuse the products or delay seeking professional help, the overall public health benefit in terms of access and convenience often outweighs these risks, provided there is adequate consumer education and clear instructions (source: various medical journals, author's general knowledge).

From a public finance perspective, increased OTC availability could lead to significant cost savings. A 2018 study estimated that OTC medicines save the U.S. healthcare system approximately $102 billion annually through avoided doctor visits and lower drug costs compared to prescription alternatives (source: chpa.org, author's assumption based on industry reports). Expanding the range of OTC options could further amplify these savings, potentially easing the burden on public health budgets and individual out-of-pocket expenses. For example, if a commonly prescribed drug for a chronic but manageable condition (e.g., certain types of hypertension or diabetes medications with low adverse event profiles) were to switch, the cumulative savings from reduced physician visits and potentially lower drug prices (due to increased competition in the OTC market) could be substantial (author's assumption).

However, it is crucial to consider potential counter-evidence. A rapid or broad shift without adequate safeguards could lead to an increase in adverse drug events, hospitalizations due to complications from self-medication, or delayed diagnosis of serious conditions masked by OTC symptom relief. Data on such outcomes for existing OTC drugs is generally positive, but the risk profile could change with more complex drugs (source: various public health reports, author's general knowledge). The cost of managing these adverse events, if they were to increase, could offset some of the initial savings in other areas of the healthcare system.

Scenarios (3) with Probabilities

Given the complexity and potential ramifications of such a policy shift, three primary scenarios emerge, each with varying probabilities and outcomes:

Scenario 1: Gradual, Targeted Deregulation (Probability: 60%)

Description: The FDA, under Makary's leadership, initiates a cautious and incremental approach to reclassification. This scenario involves the agency focusing on specific drug classes that have a well-established safety profile, a clear indication for self-treatment, and a low potential for misuse or masking serious conditions. The drugs mentioned by Makary—nausea medications and vaginal estrogen—fit this profile, representing conditions that are often self-diagnosed and managed, with existing prescription options having a favorable safety track record. The process would still involve rigorous review, but with a more proactive stance from the FDA in identifying candidates and facilitating the switch process. Public education campaigns would be a key component, emphasizing responsible self-care and the importance of consulting pharmacists or physicians when in doubt.

Rationale: This approach balances the stated goal of increasing OTC access with the FDA's fundamental mandate for public safety. It allows the agency to test the waters, gather data on the impact of initial switches, and refine its processes before considering broader changes. It also mitigates significant political and industry backlash that a more radical approach might provoke.

Impact: Moderate expansion of the OTC market, modest healthcare cost savings, increased role for pharmacists, and generally positive public health outcomes due to improved access for specific conditions.

Scenario 2: Moderate, Broadened Deregulation (Probability: 30%)

Description: Building on the initial successes or driven by stronger political will, the FDA expands its reclassification efforts to include a wider range of drug categories. This could encompass certain medications for mild hypertension, cholesterol management (e.g., low-dose statins for specific populations), or even some maintenance therapies for chronic conditions, provided they have a wide therapeutic window and clear diagnostic criteria that could be managed through digital tools or pharmacist consultation. This scenario might involve the creation of new 'behind-the-counter' or 'pharmacist-only' OTC categories, requiring a brief consultation with a pharmacist before dispensing, thereby adding a layer of professional oversight without requiring a physician's prescription. Investment in digital health platforms for symptom checking and drug interaction warnings would become more prominent.

Rationale: This scenario reflects a more ambitious interpretation of Makary's statement, pushing the boundaries of what is considered safe for self-medication while still acknowledging the need for some level of professional guidance. It would likely involve significant legislative or regulatory changes to empower pharmacists further and integrate technology into the drug dispensing process.

Impact: Substantial growth in the OTC market, significant healthcare cost savings, a transformative shift in the role of pharmacists, and a greater emphasis on consumer health literacy and digital health tools. Higher risks of adverse events if not managed carefully.

Scenario 3: Significant, Rapid Deregulation (Probability: 10%)

Description: This scenario represents a radical overhaul where the default assumption for drug classification truly shifts to OTC, and only drugs with clear and immediate safety concerns or high potential for abuse remain prescription-only. This would lead to a rapid and widespread reclassification of a large number of common prescription drugs, potentially including those for more complex chronic conditions, with minimal additional oversight beyond standard OTC labeling. The emphasis would be almost entirely on consumer responsibility, with limited new mechanisms for professional intervention. This would likely require significant legislative action to bypass existing regulatory hurdles and could face substantial opposition from medical professional organizations and public health advocates.

Rationale: This scenario aligns most directly with the most extreme interpretation of Makary's 'everything should be OTC' statement, suggesting a fundamental philosophical shift in drug regulation. However, the practical and political hurdles to such a rapid and broad change are immense.

Impact: Revolutionary transformation of the pharmaceutical and healthcare industries, potentially massive healthcare cost reductions, but also a significant increase in public health risks related to misdiagnosis, inappropriate use, and adverse drug events. Would likely face intense legal and ethical challenges.

Timelines

Implementing a policy shift of this magnitude would necessarily unfold over several phases:

1. Immediate Term (0-12 months): Initial reviews and reclassifications of specific, low-risk drugs, as indicated by Makary (e.g., nausea medications, vaginal estrogen). This phase would involve internal FDA process adjustments and engagement with manufacturers. Public announcements and initial consumer education efforts would begin. (source: cnbc.com)

2. Short to Medium Term (1-3 years): If initial switches are successful, the FDA would likely expand its list of target drugs. This period would involve developing new guidelines for OTC switches, potentially exploring 'behind-the-counter' categories, and engaging in broader stakeholder consultations. Pharmaceutical companies would begin to adjust R&D and marketing strategies. Pharmacist training and scope-of-practice discussions would intensify.

3. Medium to Long Term (3-7 years): A more comprehensive re-evaluation of the entire drug classification system could occur. This might involve legislative changes to formalize new regulatory pathways or expand the role of pharmacists. The market would fully adapt, with significant shifts in product portfolios, distribution channels, and consumer behavior. Public health outcomes (both positive and negative) would become more evident, informing further policy adjustments.

4. Long Term (7+ years): Full integration of the new philosophy into the healthcare ecosystem. Continued monitoring, refinement of regulations, and ongoing public education would be permanent features. The impact on chronic disease management and public health metrics would be fully realized.

Quantified Ranges

While precise figures are difficult to predict without specific policy details, we can project potential quantified ranges based on existing market data and historical trends:

Potential OTC Market Expansion: Under a gradual deregulation scenario, the U.S. OTC market could expand by 10-25% ($3.5 billion to $10 billion) over 3-5 years, driven by new product switches (author's assumption). Under a moderate scenario, this could be 25-50% ($10 billion to $20 billion) over 5-7 years. A significant deregulation scenario could see the OTC market double or triple, reaching $70-100 billion annually within a decade, fundamentally reshaping the pharmaceutical landscape (author's assumption).

Healthcare Cost Savings: If a moderate number of high-volume prescription drugs switch, annual healthcare system savings (from reduced doctor visits and lower drug costs) could range from $20 billion to $50 billion over 5-7 years (author's assumption, building on existing CHPA estimates). This would significantly impact public finance, particularly for government-funded healthcare programs.

Pharmaceutical R&D Reallocation: Pharmaceutical companies might reallocate 5-15% of their R&D budgets towards developing new OTC formulations or conducting switch studies for existing prescription drugs, particularly those nearing patent expiration (author's assumption).

Increase in Self-Medication Incidents: While difficult to quantify precisely, a moderate increase in OTC availability could lead to a 5-10% rise in reported incidents of inappropriate drug use or adverse events related to self-medication, particularly in the initial years (author's assumption). This would necessitate increased investment in public health surveillance and education to mitigate these risks.

Pharmacist Consultation Demand: Demand for pharmacist consultations could increase by 30-60% for newly switched OTC drugs, requiring significant investment in pharmacy staffing and training (author's assumption).

Risks & Mitigations

The proposed shift, while offering benefits, carries substantial risks that must be proactively addressed:

Risks:

1. Misdiagnosis and Delayed Treatment: Consumers may misinterpret symptoms, leading to inappropriate self-treatment and delaying professional medical attention for serious underlying conditions. For example, using an OTC antacid for persistent heartburn could mask gastric cancer (source: medical literature, author's general knowledge).
2. Inappropriate Drug Use/Overdose: Without professional guidance, individuals may use drugs incorrectly (e.g., wrong dosage, duration, or combination with other medications), leading to adverse effects, drug interactions, or overdose. The risk is higher for drugs with narrow therapeutic windows or significant side effects.
3. Lack of Professional Oversight: The absence of a prescribing physician removes a critical layer of patient monitoring, drug interaction checks, and personalized advice, which is particularly important for patients with comorbidities or complex medication regimens.
4. Exacerbation of Health Inequalities: Populations with lower health literacy, limited access to reliable health information, or language barriers may be disproportionately affected, struggling to make informed decisions about self-care.
5. Reduced R&D for Complex Diseases: If pharmaceutical companies shift focus to OTC-friendly drugs, investment in novel prescription therapies for complex, rare, or chronic diseases might diminish, impacting future medical innovation.
6. Increased Manufacturer Liability: Pharmaceutical companies may face increased legal and reputational risks if adverse events linked to newly OTC drugs are attributed to inadequate labeling or consumer education.

Mitigations:

1. Stricter and Enhanced Labeling: Require clear, concise, and easily understandable labeling that includes detailed instructions for use, warnings, potential side effects, drug interactions, and explicit guidance on when to seek professional medical advice. Utilize pictograms and simplified language (source: fda.gov, author's assumption).
2. Mandatory Pharmacist Consultation for Certain OTCs: Implement a 'behind-the-counter' category where certain newly switched OTC drugs require a brief consultation with a pharmacist before dispensing. This provides a crucial point of professional intervention and education (source: various international regulatory models, author's assumption).
3. Robust Public Education Campaigns: Launch comprehensive national campaigns to educate consumers on responsible self-medication, the importance of reading labels, understanding symptoms, and knowing when to consult a doctor or pharmacist. Utilize diverse media channels and target vulnerable populations (source: cdc.gov, author's assumption).
4. Integration of Digital Health Tools: Develop and promote digital platforms (apps, websites) that offer symptom checkers, drug interaction databases, personalized dosage reminders, and direct links to telehealth services or pharmacists. These tools can empower consumers with information and guidance (source: who.int, author's assumption).
5. Enhanced Post-Market Surveillance: Strengthen FDA's post-market surveillance capabilities to rapidly detect and analyze adverse events associated with newly OTC drugs. This would allow for timely interventions, such as label changes or reclassification (source: fda.gov).
6. Tiered OTC Classifications: Consider a more nuanced OTC classification system beyond the current binary, allowing for different levels of accessibility and oversight based on drug risk profiles (e.g., general sale, pharmacy-only, pharmacist-consultation required) (source: various international regulatory models, author's assumption).

Sector/Region Impacts

Pharmaceutical Sector:

Product Portfolios: A significant shift towards OTC could lead to a rebalancing of product portfolios, with increased investment in consumer health divisions. Companies with strong OTC brands or robust pipelines for switch candidates would gain a competitive advantage.

R&D Reallocation: R&D spending might shift from developing new prescription drugs for common conditions to either developing novel OTC formulations or conducting studies to support Rx-to-OTC switches for existing products. This could also spur innovation in drug delivery systems suitable for self-administration.

Marketing and Distribution: Marketing strategies would pivot from targeting healthcare professionals to direct-to-consumer advertising. Distribution channels might expand beyond pharmacies to include general retail outlets, e-commerce, and potentially new direct-to-consumer models.

Pricing Pressure: Increased competition in the OTC market, particularly from generics, would likely exert downward pressure on drug prices, impacting revenue streams for innovator companies.

Healthcare Providers Sector:

Physicians: Reduced patient load for minor ailments could free up physician time for more complex cases, improving efficiency in specialized care. However, it also necessitates adapting to a new patient dynamic where initial self-treatment is common.

Pharmacists: This group stands to gain significant professional expansion. Pharmacists would become primary points of contact for health advice, drug selection, and patient education regarding OTC products. This could lead to increased demand for pharmacy services, requiring investment in training, staffing, and potentially new reimbursement models for consultations.

Hospitals and Emergency Services: While intended to reduce burden, a poorly managed shift could lead to an increase in emergency room visits for adverse drug reactions or complications from delayed diagnosis, particularly in the initial phases.

Public Finance:

Healthcare Spending: The most direct impact would be on public healthcare budgets. Reduced physician visits and potentially lower drug costs for common conditions could lead to significant savings for government-funded programs (e.g., Medicare, Medicaid) and public health insurance schemes. However, these savings could be offset if adverse events or complications increase due to inadequate oversight.

Tax Revenue: Changes in pharmaceutical sales and pricing could impact corporate tax revenues, though the overall economic activity might remain stable or even grow in the consumer health segment.

Investment in Public Health: Governments might need to reallocate funds towards robust public education campaigns, enhanced post-market surveillance, and potentially expanded roles for public health nurses and community health workers to support consumer health literacy.

Infrastructure Delivery:

Pharmacy Infrastructure: Increased demand for pharmacist consultations and OTC dispensing would necessitate investment in pharmacy staffing, training, and potentially reconfiguring pharmacy layouts to accommodate more private consultation spaces.

Digital Health Infrastructure: The success of broader OTC access would heavily rely on robust digital health platforms for consumer information, symptom checking, and telehealth support. This would drive investment in health tech, data analytics, and secure patient information systems.

Supply Chain and Logistics: A shift to OTC would require pharmaceutical supply chains to adapt to higher volumes, broader distribution networks (e.g., mass retail), and potentially faster inventory turnover for popular OTC products.

Large-Cap Industry Actors:

Pharmaceutical Giants: Companies like Pfizer, Johnson & Johnson, Bayer, and GSK (which often have strong consumer health divisions) are well-positioned to capitalize on this trend. They would likely prioritize Rx-to-OTC switch applications and invest heavily in consumer marketing.

Retailers (Pharmacies, Supermarkets): Large pharmacy chains (e.g., CVS, Walgreens) and mass retailers (e.g., Walmart, Target) would see increased foot traffic and sales in their consumer health aisles. This could lead to expanded pharmacy services and greater integration of health clinics within retail spaces.

Technology Companies: Firms specializing in AI, telehealth, and digital health platforms could see increased demand for their services as the healthcare system seeks to support consumer self-care with digital tools.

Regional Impacts:

Urban vs. Rural: Increased OTC access could disproportionately benefit rural areas with limited access to physicians, improving health equity. However, rural areas might also have fewer pharmacists or less access to reliable internet for digital health tools, requiring targeted interventions.

Socioeconomic Disparities: While potentially lowering costs, the shift places a greater burden on individuals to manage their health. Regions with higher socioeconomic disparities might require more robust public health support and education to prevent negative outcomes.

Recommendations & Outlook

For governments, infrastructure developers, public finance entities, and large-cap industry actors, the potential shift in FDA policy demands proactive strategic engagement. The outlook suggests a likely, albeit gradual, movement towards greater over-the-counter availability for a broader range of medications, driven by a confluence of factors including cost containment, consumer empowerment, and technological advancements. However, this will be tempered by an unwavering commitment to public safety and the need for robust regulatory frameworks.

Recommendations for Governments and Public Finance Entities:

1. Monitor FDA Guidance Closely: Actively track FDA announcements, proposed rule changes, and specific drug reclassifications. This will inform future healthcare spending projections and policy adjustments.
2. Invest in Public Health Education: Proactively fund and develop comprehensive, multi-lingual public education campaigns on responsible self-medication, drug literacy, and the importance of professional consultation. This is a critical mitigation strategy for public safety (scenario-based assumption).
3. Support Pharmacist Scope Expansion: Explore legislative and regulatory changes to expand the scope of practice for pharmacists, including reimbursement for consultations and minor prescribing authority, to leverage their accessibility as frontline healthcare providers (scenario-based assumption).
4. Evaluate Healthcare Cost Models: Begin modeling the potential long-term impacts on public healthcare spending, considering both savings from reduced physician visits and potential costs from adverse events, to inform future budget allocations (scenario-based assumption).

Recommendations for Infrastructure Delivery:

1. Assess Pharmacy Infrastructure Needs: Conduct assessments of existing pharmacy infrastructure to identify gaps in staffing, training, and physical space required to support an expanded pharmacist role and increased OTC demand (scenario-based assumption).
2. Invest in Digital Health Integration: Prioritize investment in secure, interoperable digital health platforms that can provide reliable consumer information, support telehealth consultations, and facilitate communication between patients, pharmacists, and physicians (scenario-based assumption).
3. Supply Chain Resilience: Evaluate and strengthen pharmaceutical supply chains to handle potentially higher volumes and broader distribution requirements for OTC products, ensuring equitable access across all regions (scenario-based assumption).

Recommendations for Large-Cap Industry Actors (Pharmaceuticals, Retail, Health Tech):

1. Strategic Portfolio Review: Pharmaceutical companies should conduct a thorough review of their prescription drug portfolios to identify potential Rx-to-OTC switch candidates, particularly those nearing patent expiration or with favorable safety profiles. Invest in the necessary clinical trials and consumer studies to support switch applications (scenario-based assumption).
2. R&D Reallocation: Reallocate R&D resources to focus on developing new OTC formulations, innovative drug delivery systems suitable for self-administration, and robust consumer education materials (scenario-based assumption).
3. Enhance Consumer Engagement: Invest heavily in direct-to-consumer marketing, digital health tools, and educational content to empower consumers and ensure safe and effective use of OTC products. Collaborate with public health organizations on education initiatives (scenario-based assumption).
4. Strengthen Pharmacy Partnerships: Retailers and pharmaceutical companies should deepen partnerships with pharmacists, recognizing their evolving role as key advisors and educators in a more OTC-centric healthcare landscape. This may include joint training programs and technology integration (scenario-based assumption).
5. Data and Analytics: Leverage data analytics to monitor market trends, consumer behavior, and post-market safety data for newly switched OTC products. This will inform product development, marketing, and risk mitigation strategies (scenario-based assumption).

Outlook:

The most probable outlook is a gradual but significant transformation of the pharmaceutical and healthcare landscape. The FDA, under current leadership, appears poised to facilitate more Rx-to-OTC switches, starting with low-risk, high-volume medications. This will likely lead to increased consumer access, convenience, and potentially substantial healthcare cost savings. However, the pace and breadth of this shift will be heavily influenced by the successful implementation of initial switches, the ability to mitigate public health risks through robust education and oversight, and the evolving political and regulatory environment. The role of pharmacists is set to expand dramatically, becoming central to guiding consumers through an increasingly complex self-care environment. While a radical, rapid deregulation is less likely due to inherent safety concerns and institutional inertia, the direction of travel points towards a future where more common ailments are managed outside the traditional physician's office, placing greater responsibility and empowerment in the hands of the consumer (scenario-based assumptions).