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Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications Opinion: Transforming U.S. Drug Policy for Better Drug Safety
With key health agencies under new leadership, there are real, concrete ways to reform drug safety and accountability to protect all Americans.
February 25, 2025
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The Trump administration sparked much speculation about what the nominees to lead the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) would do once confirmed by the Senate.
Now that Robert F Kennedy Jr. has been confirmed to lead HHS, we’re starting to get a better idea of what the next four years might hold, though nothing is certain. While past statements provide some indication of priorities and points of view, one thing is for sure: None of these positions come with a magic wand.
Traditionally, each appointee is faced with the critical task of first ensuring that their respective organizations continue to fulfill their core mandate: protecting and improving public health. Many Americans depend on vital programs like Medicaid and Medicare, and any drastic changes to these programs could lead to significant hardship, widespread concern and potential outrage.
Research, particularly in the medical and pharmaceutical fields, takes years to design, execute, and evaluate. Any termination of well-progressed studies would be a waste of public funds already spent. Furthermore, pharmaceutical companies wield considerable influence in Congress, making it a herculean task to insulate the HHS, CDC, and FDA from their influence—though such an effort is essential.
Some public positions may be easier to implement, allowing nominees to deliver on political expectations. For example, Robert F. Kennedy Jr. might act on his promise to fight fluoride in community drinking water (while I’m not in unequivocal agreement, no scientific question should be held so sacred that it cannot be reviewed in light of new scientific knowledge). Given his involvement in the dietary supplement industry, Mehmet Oz, M.D., might be expected to make it easier for certain distributors to make health claims without substantial scientific backing (which I think is a terrible idea). While these changes would be noteworthy, I am focused on bigger changes.
This Year, Let’s Go Big
I have my mind on more foundational, far-reaching changes and meaningful reforms that would make U.S. drug research, manufacturing and distribution safer, more effective, and more equitable for all Americans. My ideas would require change on a foundational level and would cost money, which the incoming administration has vowed to cut. Are these ideas doable? I have no idea.
What I do know: I’m making wishes.
Here are my top three priorities.
1. Strengthen Drug Manufacturing Safety
More than 16,603 medicines have been recalled since 2012 — that’s more than 3.5 medications each day. Most of the recalls are for manufacturing defects: These defects often include undeclared ingredients (such as an excess of NDMA (Nitrosodimethylamine), which can raise your cancer risk, in certain brands of metformin); issues with pill dissolution, which can cause the drug to enter the system too quickly or unevenly; or contamination (like Delsam Pharma’s eye drops, which were tainted with a drug-resistant strain of pseudomonas aeruginosa bacteria and caused 14 people to lose their vision, and another four to die).
While rigorous testing is meant to prevent these problems, they still occur. Even before mass production, key steps in the generic drug approval process—such as independent lab studies—are supposed to confirm that the generic is equivalent to the brand-name drug in terms of content and dissolution. However, some labs have been caught falsifying this data. A recent case in India saw a lab submitting faulty data for years, affecting about 400 generic drugs and a smaller amount of brand name drugs. Despite this, the FDA has allowed these drugs to remain on the market without informing the public which drugs are unsafe.
This is unacceptable. The FDA’s primary responsibility is to ensure that all drugs are both safe and effective, and any deviation from this must be addressed swiftly.
2. Quickly Remove Drugs That Fail Post-Market Testing
More than half of the new drugs approved in the past few years received a status that allowed them to be approved through an accelerated pathway, which means they have to show results of only one clinical trial instead of two (the second to verify the first); additionally, such trials are often allowed to be shorter and have fewer participants. The FDA allows this when the proposed drug addresses an unmet and urgent need, and shows promise.
These four main pathways are: Fast Track, Priority Review, Breakthrough Therapy, and Accelerated Approval. Drugs approved with these designations have a requirement for follow-up testing to confirm their safety and efficacy.
When a drug fails to meet its required post-market research obligations or demonstrates harm in follow-up studies, the requirement is that it must be removed from the market promptly. But too often, drugs linger in the market even after they have failed these critical tests, putting patients at unnecessary risk. An example of this would be a drug sometimes given to pregnant women called Makena. The makers of Makena were given 10 years by the FDA to prove efficacy in preventing pre-term birth. When a 2019 study by the drug maker did not provide the necessary evidence of efficacy, the FDA asked the pharmaceutical company to withdraw the drug voluntarily. The company refused and it took another four years until the FDA required the company to withdraw Makena.
The FDA must be more proactive in swiftly addressing any drugs that fail post-market evaluations and removing them from circulation.
At the same time, the FDA must hold drug companies accountable for conducting their research on time and on the agreed schedule. NPR conducted a review of all approved drugs requiring post-approval research and found that 42% (a total of 50) of follow-up studies were delayed by more than a year or had not started at all. Among these, 19 studies had not started even three years after approval, and four have yet to begin more than a decade later.
3. Mandate Long-Term Follow-Up Studies for All Approved Drugs and Drug Safety
Currently, most drugs are tested on just a few thousand people before they are approved. This small sample size often misses long-term side effects that may not appear until millions of people take the drug over an extended period. However, reporting adverse events remains voluntary, and the required forms are detailed and may be time-consuming for doctors and patients to complete. As a result, harmful side effects may be under-reported.
To address this, I propose that the FDA mandate long-term follow-up studies for all approved drugs, especially those taken by large populations. Similar to the follow-up systems used during the COVID-19 vaccination campaign, patients could be contacted by email or text and asked to report side effects regularly—initially, soon after taking the drug, then one week, one month, and one year later. Annual reminders could help capture side effects that take years to surface. Such a system would not only improve patient safety, but also provide valuable data for future drug approvals.
Bonus: Redirect NIH Funding Toward Marijuana Research
As marijuana use becomes more widespread, we need to understand its effects better, both for recreational users and those using it for medical purposes. The FDA has approved marijuana-derived compounds for certain uses, but there is only limited research into the long-term effects of its casual use. There are different strains of marijuana, such as sativa, indica, and hybrid strains, and each may have different effects. This is an area that warrants significant investment from the National Institutes of Health (NIH), as they are uniquely positioned to conduct the long-term, comprehensive studies needed. This research could help guide public policy, inform safety standards, and improve the quality of life for users.
Our drug manufacturing and distribution system is vast and complex, but these changes—strengthening manufacturing safety, enforcing rigorous post-market testing, and ensuring long-term monitoring of side effects—are steps that could make a meaningful impact on the health and safety of Americans. By prioritizing these reforms, we can ensure that our healthcare system is not only more effective but also more accountable to the public it serves.
Want to Share Your Story?
If you’ve experienced side effects or medication issues related to this topic, we want to hear from you.
Submit Your Story- FDA dashboards – recalls. (n.d.)
- Adamson, R. H., & Chabner, B. A. (2020). The finding of N-Nitrosodimethylamine in common medicines. The Oncologist, 25(6), 460–462.
- Research, C. F. D. E. A. (2023, January 10). New drug therapy approvals 2022. U.S. Food And Drug Administration.
- Office of the Commissioner. (2024, August 13). Fast track. U.S. Food And Drug Administration.
- Office of the Commissioner. (2018, January 4). Priority review. U.S. Food And Drug Administration.
- Office of the Commissioner. (2018, January 4). Breakthrough Therapy. U.S. Food And Drug Administration.
- Research, C. F. D. E. A. (2024, February 22). Accelerated Approval Program. U.S. Food And Drug Administration.
- Office of the Commissioner. (2023, April 6). FDA Commissioner and Chief scientist announce decision to withdraw approval of Makena. U.S. Food And Drug Administration.
- Lupkin, S. (2022, July 22). Drugmakers are slow to prove medicines that got a fast track to market really work. NPR.
- Office of the Commissioner. (2018, January 4). Step 3: Clinical research. U.S. Food And Drug Administration.
- García-Abeijon, P., Costa, C., Taracido, M., Herdeiro, M. T., Torre, C., & Figueiras, A. (2023). Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update. Drug Safety, 46(7), 625–636.
- Muro, A., Cladellas, R., & Castellà, J. (2021). Cannabis and its different strains. Experimental Psychology (Formerly Zeitschrift Für Experimentelle Psychologie), 68(2), 57–66.
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Article HTML
<!-- wp:paragraph -->
<p>The Trump administration sparked much speculation about what the nominees to lead the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) would do once confirmed by the Senate.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Now that Robert F Kennedy Jr. has been confirmed to lead HHS, we’re starting to get a better idea of what the next four years might hold, though nothing is certain. While past statements provide some indication of priorities and points of view, one thing is for sure: None of these positions come with a magic wand.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Traditionally, each appointee is faced with the critical task of first ensuring that their respective organizations continue to fulfill their core mandate: protecting and improving public health. Many Americans depend on vital programs like Medicaid and Medicare, and any drastic changes to these programs could lead to significant hardship, widespread concern and potential outrage.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Research, particularly in the medical and pharmaceutical fields, takes years to design, execute, and evaluate. Any termination of well-progressed studies would be a waste of public funds already spent. Furthermore, pharmaceutical companies wield considerable influence in Congress, making it a herculean task to insulate the HHS, CDC, and FDA from their influence—though such an effort is essential.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Some public positions may be easier to implement, allowing nominees to deliver on political expectations. For example, Robert F. Kennedy Jr. might act on his promise to fight fluoride in community drinking water (while I’m not in unequivocal agreement, no scientific question should be held so sacred that it cannot be reviewed in light of new scientific knowledge). Given his involvement in the dietary supplement industry, Mehmet Oz, M.D., might be expected to make it easier for certain distributors to make health claims without substantial scientific backing (which I think is a terrible idea). While these changes would be noteworthy, I am focused on bigger changes.</p>
<!-- /wp:paragraph --><!-- wp:heading -->
<h2 class="wp-block-heading" id="h.nlsyqdrbjank">This Year, Let’s Go Big</h2>
<!-- /wp:heading --><!-- wp:paragraph -->
<p>I have my mind on more foundational, far-reaching changes and meaningful reforms that would make U.S. drug research, manufacturing and distribution safer, more effective, and more equitable for all Americans. My ideas would require change on a foundational level and would cost money, which the incoming administration has vowed to cut. Are these ideas doable? I have no idea.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>What I do know: I’m making wishes.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Here are my top three priorities.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h.pdkl04mx9epn">1. Strengthen Drug Manufacturing Safety</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p>More than <a href="https://datadashboard.fda.gov/ora/cd/recalls.htm" target="_blank" rel="noreferrer noopener">16,603 medicines have been recalled</a> since 2012 — that’s more than 3.5 medications each day. Most of the recalls are for manufacturing defects: These defects often include undeclared ingredients (such as an excess of NDMA (Nitrosodimethylamine), which can <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC7288647/" target="_blank" rel="noreferrer noopener">raise your cancer </a><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC7288647/" target="_blank" rel="noreferrer noopener">risk</a>, in certain brands of metformin); issues with pill dissolution, which can cause the drug to enter the system too quickly or unevenly; or contamination (like <a href="https://medshadow.org/drug-recalls/" target="_blank" rel="noreferrer noopener">Delsam Pharma’s eye drops</a>, which were tainted with a drug-resistant strain of pseudomonas aeruginosa bacteria and caused 14 people to lose their vision, and another four to die).</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>While rigorous testing is meant to prevent these problems, they still occur. Even before mass production, key steps in the generic drug approval process—such as independent lab studies—are supposed to confirm that the generic is equivalent to the brand-name drug in terms of content and dissolution. However, some labs have been caught falsifying this data. A recent case in <a href="https://medshadow.org/hundreds-of-drugs-remain-on-the-market-after-fraudulent-trials/" target="_blank" rel="noreferrer noopener">India saw a lab submitting faulty data for </a><a href="https://medshadow.org/hundreds-of-drugs-remain-on-the-market-after-fraudulent-trials/" target="_blank" rel="noreferrer noopener">years</a>, affecting about 400 generic drugs and a smaller amount of brand name drugs. Despite this, the FDA has allowed these drugs to remain on the market without informing the public which drugs are unsafe.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><a href="https://medshadow.org/open-letter-to-the-fda-youre-protecting-the-wrong-people/" target="_blank" rel="noreferrer noopener">This is unacceptable</a>. The FDA’s primary responsibility is to ensure that all drugs are both safe and effective, and any deviation from this must be addressed swiftly.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h.qb87xr6m6qbx">2. Quickly Remove Drugs That Fail Post-Market Testing</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><a href="https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022" target="_blank" rel="noreferrer noopener">More than half</a><a href="https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022" target="_blank" rel="noreferrer noopener"> of the new drugs approved i</a>n the past few years received a status that allowed them to be approved through an accelerated pathway, which means they have to show results of only one clinical trial instead of two (the second to verify the first); additionally, such trials are often allowed to be shorter and have fewer participants. <a href="https://medshadow.org/about-fda-drug-development-process-risk-of-side-effects/" target="_blank" rel="noreferrer noopener">The FDA allows this</a> when the proposed drug addresses an unmet and urgent need, and shows promise.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>These four main pathways are: <a href="https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track" target="_blank" rel="noreferrer noopener">Fast Track</a>, <a href="https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review" target="_blank" rel="noreferrer noopener">Priority Review</a>, <a href="https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy" target="_blank" rel="noreferrer noopener">Breakthrough Therapy</a>, and <a href="https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program" target="_blank" rel="noreferrer noopener">Accelerated Approval</a>. Drugs approved with these designations have a requirement for follow-up testing to confirm their safety and efficacy.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>When a drug fails to meet its required post-market research obligations or demonstrates harm in follow-up studies, the requirement is that it must be removed from the market promptly. But too often, drugs linger in the market even after they have failed these critical tests, putting patients at unnecessary risk. An example of this would be a drug sometimes given to pregnant women called <a href="https://medshadow.org/makena-off-the-market/" target="_blank" rel="noreferrer noopener">Makena</a><a href="https://medshadow.org/makena-off-the-market/" target="_blank" rel="noreferrer noopener">. </a>The makers of Makena were given 10 years by the FDA to prove efficacy in preventing pre-term birth. When a 2019 study by the drug maker <a href="https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena?" target="_blank" rel="noreferrer noopener">did not provide the necessary evidence of efficacy</a>, the FDA asked the pharmaceutical company to withdraw the drug voluntarily. The company refused and it took another four years until the FDA required the company to withdraw Makena.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>The FDA must be more proactive in swiftly addressing any drugs that fail post-market evaluations and removing them from circulation.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>At the same time, the FDA must hold drug companies accountable for conducting their research on time and on the agreed schedule. <a href="https://www.npr.org/sections/health-shots/2022/07/22/1110830985/drugmakers-are-slow-to-prove-medicines-that-got-a-fast-track-to-market-really-wo" target="_blank" rel="noreferrer noopener">NPR conducted a review</a> of all approved drugs requiring post-approval research and found that 42% (a total of 50) of follow-up studies were delayed by more than a year or had not started at all. Among these, 19 studies had not started even three years after approval, and four have yet to begin more than a decade later.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h.bcv11v7jjsqn"> 3. Mandate Long-Term Follow-Up Studies for All Approved Drugs and Drug Safety</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p>Currently, most drugs are tested on <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research" target="_blank" rel="noreferrer noopener">just a few thousand people</a> before they are approved. This small sample size often misses long-term side effects that may not appear until millions of people take the drug over an extended period. However, reporting adverse events remains voluntary, and the required forms are detailed and may be time-consuming for doctors and patients to complete. As a result, harmful side effects <a href="https://link.springer.com/article/10.1007/s40264-023-01302-7?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">may be under-reported</a>.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>To address this, I propose that the FDA mandate long-term follow-up studies for all approved drugs, especially those taken by large populations. Similar to the follow-up systems used during the COVID-19 vaccination campaign, patients could be contacted by email or text and asked to report side effects regularly—initially, soon after taking the drug, then one week, one month, and one year later. Annual reminders could help capture side effects that take years to surface. Such a system would not only improve patient safety, but also provide valuable data for future drug approvals.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h.2rp4w9sl8y7o">Bonus: Redirect NIH Funding Toward Marijuana Research</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p>As marijuana use becomes more widespread, we need to understand its effects better, both for recreational users and those using it for medical purposes. The FDA has approved marijuana-derived compounds for certain uses, but there is only limited research into the long-term effects of its casual use. There are different strains of marijuana, such as sativa, indica, and hybrid strains, and <a href="https://www.researchgate.net/publication/352663634_Cannabis_and_Its_Different_Strains_Do_They_Have_Differential_Effects_on_Time_Perception" target="_blank" rel="noreferrer noopener">each may have different effects</a>. This is an area that warrants significant investment from the National Institutes of Health (NIH), as they are uniquely positioned to conduct the long-term, comprehensive studies needed. This research could help guide public policy, inform safety standards, and improve the quality of life for users.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Our drug manufacturing and distribution system is vast and complex, but these changes—strengthening manufacturing safety, enforcing rigorous post-market testing, and ensuring long-term monitoring of side effects—are steps that could make a meaningful impact on the health and safety of Americans. By prioritizing these reforms, we can ensure that our healthcare system is not only more effective but also more accountable to the public it serves.</p>
<!-- /wp:paragraph -->