Prescription Drug Regulation, Cost, and Access: Current Controversies in Context from edX

Prescription drugs are among the most common health care interventions and have turnedsome once-fatal diseases into manageable conditions — but they have also been a growing source of controversy. Patients in the US struggle with increasing costs and express concerns about whymany conditions,such as Alzheimer’s disease, remain without adequate therapeutic options.

At the center of these debates lies the US Food and Drug Administration (FDA), a federal agency responsible for monitoring the prescription drug marketplace and enforcing basic rules and laws that affect how prescription drugs are discovered, developed, and sold.

This course investigates the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You willlearn the rules and regulationsgoverning the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.

What you'll learn

Key controversies over how prescription drugs are developed and marketed, and why those controversies exist
The FDA — its history, public health role, and rules affecting prescription drugs in the US
The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval
The cost of prescription drugs, including the factors affecting a drug’s market exclusivity period and the availability and use of affordable generic drugs
Safety evaluation of prescription drugs using “real world” data
Current topics stirring debate over the scope of FDA regulation, such as dietary supplements, special classes of prescription drugs, and “right to try” lawsthat allow patients to obtain drugs prior to FDA approval
Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients

What's inside

Learning objectives

Key controversies over how prescription drugs are developed and marketed, and why those controversies exist
The fda — its history, public health role, and rules affecting prescription drugs in the us
The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval
The cost of prescription drugs, including the factors affecting a drug’s market exclusivity period and the availability and use of affordable generic drugs

Safety evaluation of prescription drugs using “real world” data
Current topics stirring debate over the scope of fda regulation, such as dietary supplements, special classes of prescription drugs, and “right to try” lawsthat allow patients to obtain drugs prior to fda approval
Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients

Key controversies over how prescription drugs are developed and marketed, and why those controversies exist
The fda — its history, public health role, and rules affecting prescription drugs in the us
The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval
The cost of prescription drugs, including the factors affecting a drug’s market exclusivity period and the availability and use of affordable generic drugs
Safety evaluation of prescription drugs using “real world” data
Current topics stirring debate over the scope of fda regulation, such as dietary supplements, special classes of prescription drugs, and “right to try” lawsthat allow patients to obtain drugs prior to fda approval
Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients

Syllabus

Module 1: Overview and history of the FDA

Module 2: Drug development and approval

Module 3: Drug pricing in the United States

Module 4: Marketing strategies

Traffic lights

Read about what's good

what should give you pause

and possible dealbreakers

Explores the history and role of the US Food and Drug Administration (FDA) in prescription drug regulation

Examines the key controversies surrounding prescription drug development and marketing, providing insights into industry perspectives

Taught by renowned experts in the field, including Jerry Avorn, Aaron Kesselheim, Jonathan Darrow, and Ameet Sarpatwari

Covers emerging topics in drug regulation, such as dietary supplements, special drug classes, and right-to-try laws

Provides a comprehensive overview of the current landscape of prescription drug regulations in the United States

May require prior knowledge in pharmacology for a deeper understanding of some concepts

Reviews summary

Understanding us drug regulation and cost

According to learners, this course provides deep insight into US prescription drug regulation, cost, and access. Students praise the expert instruction and the relevant content covering FDA history and processes, drug development, pricing mechanisms, and current controversies. The course is seen as highly valuable for understanding the complexities of the pharmaceutical market. Some note the challenging pace due to the depth of material and that the focus is primarily US-centric. Overall, it is considered a comprehensive and insightful look at a critical topic.

Addresses current debates in drug policy.

"The course directly tackles current controversial topics around drug cost, access, and 'right to try' laws, which was highly informative."

"It helped me understand the complex factors and historical context behind headlines about drug pricing and availability."

"Discussing drug marketing rules and their impact on physician and patient behavior was very relevant to my work."

Taught by leading experts from Harvard.

"The lectures were delivered by experts who clearly know their subject matter inside and out, offering valuable real-world context."

"I appreciated the insights provided by the Harvard faculty; their knowledge made complex topics easier to grasp."

"Instructors explained difficult concepts related to FDA processes and legal frameworks very clearly and engagingly."

Comprehensive look at US drug regulation

"Provides a comprehensive look at the entire lifecycle of prescription drugs, from discovery to post-market surveillance."

"I gained a deep understanding of the complex regulatory landscape and current debates surrounding drug access."

"This course is highly relevant to anyone working in or interested in the pharmaceutical industry, public health policy, or healthcare law."

"It covered all the key areas mentioned in the syllabus thoroughly."

Primarily focused on the US system.

"As an international student, I found the heavy focus on the US system limited its direct applicability to my region, though it offered valuable comparative insights."

"While relevant insights were provided, it would have been helpful to include more comparative global perspectives on regulation and pricing."

"Learners outside the US should note this course is primarily centered on FDA regulations and US law regarding prescription drugs."

Material is dense and moves quickly.

"There is a lot of information packed into each module, requiring significant time investment and dedication to keep up."

"I found the pace quite fast at times, especially the sections detailing specific regulatory procedures and legal nuances."

"Be prepared to spend extra time reviewing the material and supplementary readings to fully absorb everything."

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Prescription Drug Regulation, Cost, and Access: Current Controversies in Context with these activities:

Read 'The Emperor of All Maladies' by Siddhartha Mukherjee

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Provides a comprehensive overview of the history, science, and human impact of cancer, enhancing understanding of the complexities of drug development and the challenges of treating diseases.

View The Song of the Cell: An Exploration of... on Amazon

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Read the book and take notes on key concepts and arguments
Summarize the book's main themes and their relevance to the course material

Review the fundamentals of pharmacology

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Refreshes knowledge on the basic principles of pharmacology, ensuring a strong foundation for understanding the course material.

Browse courses on Pharmacokinetics

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Read textbook chapters on pharmacokinetics and pharmacodynamics
Review lecture notes or online resources on drug metabolism and drug interactions

Explore the FDA website

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Provides a hands-on opportunity to navigate the FDA website, fostering familiarity with the agency's structure and resources.

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Visit the FDA website
Explore different sections of the website, such as drug approvals, safety alerts, and consumer information
Read and summarize key information on the FDA's mission and regulatory processes

Four other activities

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Volunteer at a local pharmacy

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Offers practical experience in pharmacy settings, reinforcing knowledge of drug dispensing, patient counseling, and healthcare regulations.

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Contact local pharmacies and inquire about volunteer opportunities
Attend volunteer orientation and training sessions
Assist pharmacists with tasks such as dispensing medications, counseling patients, and maintaining inventory

Analyze drug advertisements

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Strengthens critical thinking skills by examining drug advertisements and evaluating their accuracy and potential biases.

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Collect drug advertisements from various sources
Analyze the advertisements for claims, evidence, and potential conflicts of interest
Write a summary of your findings, discussing the strengths and weaknesses of the advertisements

Debate the ethical implications of drug development

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Encourages critical thinking and ethical reasoning by engaging in discussions on the complex moral dilemmas surrounding drug development.

Browse courses on Drug Development

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Prepare arguments for and against different ethical considerations
Participate in a structured debate, presenting and defending your viewpoints
Reflect on the ethical implications and develop a personal stance on the issues discussed

Write a research proposal on a drug-related topic

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Challenges students to apply their knowledge by designing a research proposal that investigates a specific drug-related question, promoting critical thinking and research skills.

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Identify a research question related to drug development, regulation, or clinical use
Develop a research plan, including hypotheses, methods, and expected outcomes
Write a research proposal outlining the research plan and its significance

Career center

Learners who complete Prescription Drug Regulation, Cost, and Access: Current Controversies in Context will develop knowledge and skills that may be useful to these careers:

Medical Affairs Manager

A Medical Affairs Manager is commonly responsible for driving the commercial strategies of a pharmaceutical product, including development, portfolio management, marketing, and regulatory operations. These Managers are often in charge of data management, which may include analyzing the real-world results of a drug to support or expand marketing claims, perform meta-analyses of clinical data, evaluate the safety of new drug products, and more. Those interested in healthcare management or with a strong interest in business and finance may find this role profitable. Taking this course could help one develop a competitive advantage for such a role by providing working knowledge of the FDA approval process and a deep understanding of the challenges in moving a drug from development to market.

See salaries and explore the career path for Medical Affairs Manager

Clinical Research Scientist

A Clinical Research Scientist, also known as a Clinical Research Associate, is an individual who works on collecting, analyzing, and overseeing clinical data. These scientists often specialize in a therapeutic area, such as oncology or cardiovascular medicine, with an ultimate career goal as a physician, or a translational science role downstream in drug development. This course is relevant to the role as it covers the entire spectrum of drug development and approval, including working with real-world data. This knowledge would aid in making research methodologies more effective, improve data interpretation, and elevate a Clinical Research Scientist's awareness of regulatory compliance and drug safety.

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Pharmacist

Pharmacists provide life-saving medications in a healthcare setting. They also advise medical doctors on the correct prescription of medications, drug dosages, and interactions, which gives them insight into the real-world effects of different drugs, especially in chronic conditions. This course would help a Pharmacist broaden their understanding of the drug approval process, the complexities of the pharmaceutical market, and the future of healthcare. By understanding the upstream decisions that impact their downstream work, a Pharmacist could improve patient care at a retail pharmacy or as a clinical pharmacist in a hospital setting.

See salaries and explore the career path for Pharmacist

Healthcare Consultant

A Healthcare Consultant is often a life science professional with an interest in strategy and finance. They may provide advice to pharmaceutical companies or medical device manufacturers on a variety of topics, including product development, marketing, sales, and operations. They also analyze market trends and provide recommendations to clients on how to improve their performance. This course may be helpful for those interested in entering healthcare consulting, as it provides a comprehensive overview of the pharmaceutical industry. It covers the regulatory environment, drug development, pricing, and marketing, which are all key areas of interest for healthcare consulting professionals.

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Toxicologist

Toxicologists evaluate the safety of chemical substances, which may include pharmaceuticals. They design and conduct studies to assess the potential risks of these substances to human health and the environment. This course would provide a comprehensive understanding of the drug approval process and the factors that are considered when evaluating the safety of a new drug.

See salaries and explore the career path for Toxicologist

Patent Attorney

A patent attorney is an expert in the field of intellectual property law. They advise clients on how to protect their inventions, including obtaining patents, trademarks, and copyrights. Patent attorneys who specialize in the pharmaceutical industry must have a strong understanding of the drug development process and the regulatory environment. Understanding the criteria for drug approval and the various strategies companies use to avoid or invalidate patents could be very beneficial.

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Biostatistician

A Biostatistician works with the design of clinical trials, collection and analysis of clinical data, and interpretation of clinical trial results. They sometimes work with the FDA to ensure that the safety and efficacy data of new drugs or medical devices is valid and supportable by the data. The course would provide valuable knowledge on regulatory processes and would also be especially helpful in learning to interpret clinical trial data, which is a key component of a Biostatistician's work.

See salaries and explore the career path for Biostatistician

Epidemiologist

An Epidemiologist is a scientist who studies the distribution and patterns of health events and diseases in a population. They use this information to identify risk factors and develop strategies for preventing and controlling diseases. Taking this course would help an aspiring or practicing Epidemiologist advance their understanding of drug-related health problems and provide more opportunities to make significant contributions to this field of research.

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Science Writer

A Science Writer is responsible for communicating complex scientific information to a lay audience. This may include writing articles, press releases, and other materials for a variety of media outlets. Taking this course would help an aspiring Science Writer gain a deeper understanding of the drug approval process and the challenges facing the pharmaceutical industry.

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Health Policy Analyst

A Health Policy Analyst researches, develops, and evaluates policies that affect the health of a population. They may work for government agencies, non-profit organizations, or private companies.

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Regulatory Affairs Manager

A Regulatory Affairs Manager ensures that their pharmaceutical company is in compliance with all applicable laws and regulations. They work closely with the FDA and other regulatory agencies to ensure that products are safe and effective.

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Medical Device Sales Representative

A Medical Device Sales Representative sells medical devices to hospitals, clinics, and other healthcare providers. They may also provide training on how to use the devices.

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Pharmaceutical Sales Representative

A Pharmaceutical Sales Representative sells prescription drugs to doctors and other healthcare providers.

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Quality Assurance Manager

A Quality Assurance Manager ensures that a pharmaceutical company's products are manufactured in accordance with good manufacturing practices (GMPs).

See salaries and explore the career path for Quality Assurance Manager

Clinical Data Manager

A Clinical Data Manager manages clinical data for clinical trials. They ensure that data is accurate, complete, and compliant with regulatory requirements.

See salaries and explore the career path for Clinical Data Manager