Tag: FDA

Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

The FDA Backdoor to MDMA Rescheduling

Vincent Joralemon Leave a comment

By Vincent Joralemon

MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long.

A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward.

Read More

Doctor working with modern computer interface.

Thank Ketamine for the Telehealth Extension

Vincent Joralemon Leave a comment

By Vincent Joralemon

In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.

One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.

Read More

Washington, D.C. skyline with highways and monuments.

Psychedelic Lobbying and Regulatory Capture

Vincent Joralemon Leave a comment

By Vincent Joralemon

Psychedelic companies and advocacy groups are spending substantial resources to influence regulatory policy, shaping what the blossoming field will ultimately cohere into.

Although regulations are designed to protect the public interest, the rulemaking process is often dominated by lobbying from those with special interests in the fields meant to be regulated. When that leads to undue influence, the result is known as “regulatory capture.”

Yet, not all lobbying campaigns are necessarily problematic — the goal instead should be for regulators to leverage industry insights while maintaining independence in their ultimate decision-making.

Read More

Operating room Doctor or Surgeon anatomy on Advanced robotic surgery machine.

Protecting Consumer Privacy in DTC Tissue Testing

Adithi Iyer Leave a comment

By Adithi Iyer

In my last piece, I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. Now, as promised, a closer look at the “who” and “how” of protecting the consumer at the heart of direct-to-consumer precision medicine. While several potential consumer interests are at stake with these services, at top of mind is data privacy — especially when the data is medically relevant and incredibly difficult to truly de-anonymize.

As we’ve established, the data collected by a tissue-based service will be vaster and more varied than we’ve seen before, magnifying existing issues with traditional data privacy. Consumer protections for this type of information are, in a word, complicated. A singular “authority” for data privacy does not exist in the United States, instead being spread among individual state data privacy statutes and regulatory backstops (with overlapping sections of some federal statutes in the background). In the context of health, let alone highly sophisticated cell signaling and microenvironment data, the web gets even more tangled.

Read More

sample tube in female hands with pipette.

Why We Should Care About the Move from Saliva to Living Cells in Precision Medicine

Adithi Iyer Leave a comment

By Adithi Iyer

The cultural, informational, and medical phenomenon that is 23andMe has placed a spotlight on precision medicine, which seeks to personalize medical care to each patient’s unique makeup. Thus far, advances in direct-to-consumer genetic testing have made saliva-sample sequencing services all the rage in this space, but regenerative medicine, which relies on cells and tissues, rather than saliva, now brings us to a new, increasingly complex inflection point.

While collecting and isolating DNA samples from saliva may offer a wealth of information regarding heredity, disease risk, and other outflows of the “instruction manual” for patients, analyzing cells captures the minutiae of patients that goes “beyond the book” and most closely informs pathology. Disease isn’t always “written in the stars” for patients. Epigenetic changes from environmental exposures, cell-to-cell signaling behaviors, and the mutations present in diseased cells all profoundly inform how cells behave in whether and how they code the instructions that DNA offers. These factors are critical to understanding how disease materializes, progresses, and ultimately responds to treatment. This information is highly personal to each patient, and reflects behavioral factors as well as genetics.

Regenerative medical technologies use cell- and tissue-based methods to recapitulate, bioengineer, and reprogram human tissue, making a whole suite of sci-fi-sounding technologies an ever-closer reality. With cell-based and other regenerative therapies entering the market (making up an entire FDA subgroup), it well worth considering how cell-based medicine can advance the world of personalized consumer testing. In other words, could a corporate, direct-to-consumer cell-based testing service be the next 23andMe? And what would that mean for patients?

Read More

Three blister packs of birth control pills on a pink background.

Opill’s FDA Approval: Implications for Pharmaceutical Regulation and Access to Care

James Jolin 1 Comment

By James René Jolin and Susannah Baruch

On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. While the timeline for availability and price of Opill will ultimately be set by its manufacturer, Perrigo, this recent move represents a significant step forward in improving access to contraceptive health care. Indeed, shortly after Opill’s approval, the American College of Obstetricians and Gynecologists described the FDA’s decision as “a critically important advancement in the accessibility of reproductive health care.”

In response to this development, Petrie-Flom Center intern James René Jolin and Executive Director Susannah Baruch sat down to discuss its legal, regulatory, and public health implications. This interview has been edited for brevity and clarity.

Read More

Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

FDA Solicits Feedback on the Use of AI and Machine Learning in Drug Development

Matthew Chun Leave a comment

By Matthew Chun

The U.S. Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. On May 10, FDA published a discussion paper on this topic and requested feedback “to enhance mutual learning and to establish a dialogue with FDA stakeholders” and to “help inform the regulatory landscape in this area.” In this blog post, I will summarize the main themes of the discussion paper, highlighting areas where FDA seems particularly concerned, and detailing how interested parties can engage with the agency on these issues.

Read More

AI-generated image of robot doctor with surgical mask on.

Who’s Liable for Bad Medical Advice in the Age of ChatGPT?

Matthew Chun Leave a comment

By Matthew Chun

By now, everyone’s heard of ChatGPT — an artificial intelligence (AI) system by OpenAI that has captivated the world with its ability to process and generate humanlike text in various domains. In the field of medicine, ChatGPT already has been reported to ace the U.S. medical licensing exam, diagnose illnesses, and even outshine human doctors on measures of perceived empathy, raising many questions about how AI will reshape health care as we know it.

But what happens when AI gets things wrong? What are the risks of using generative AI systems like ChatGPT in medical practice, and who is ultimately held responsible for patient harm? This blog post will examine the liability risks for health care providers and AI providers alike as ChatGPT and similar AI models increasingly are used for medical applications.

Read More

Supreme Court of the United States.

The Federal Judiciary Is Broken — But Not for the Reason You Think

Jennifer S. Bard Leave a comment

By Jennifer Bard

Recent events, including the discovery that Justice Thomas has been accepting luxury vacations from and selling real estate to a billionaire, and the Fifth Circuit’s finding in Alliance for Hippocratic Medicine v. FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. But they’re not. Both involve a threat to our constitutional government and both highlight the need to shield all federal decision makers from entities with billions at stake and a fiduciary interest in increasing the value of their company for the benefit of shareholders. And while issues of influence affecting Supreme Court Justices attract the most attention, the factors that make Justices targets extend across the entire federal judiciary.

Read More