Shedding Light on the Risks
& Benefits of Medications
Generic drugs dominate prescriptions in the U.S. But manufacturing shortcuts and overseas oversight gaps may be putting millions at risk.
Experts unpack what patients should know about generic drugs, quality concerns, and FDA oversight.
Eight years ago, Lisa Salberg, now 56, received a heart transplant at Newark Beth Israel Medical Center in New Jersey after living with hypertrophic cardiomyopathy (a heart muscle disorder that reduces blood flow through the ventricles) since childhood. Post-procedure, she was prescribed tacrolimus, the main oral medication responsible for preventing the body from rejecting a new heart.
After her 2017 surgery, she began taking a generic form of tacrolimus manufactured by a company called Accord. But on multiple occasions over the next few years, her pharmacy couldn’t source the Accord product, forcing her to switch to tacrolimus made by other manufacturers.
Hoping to avoid further medication switches, Salberg reviewed the list of tacrolimus manufacturers available through her pharmacy. She then asked the pharmacist to switch her to a version made by Sandoz, a company she recognized as having its U.S. headquarters in her home state of New Jersey.
After she began taking Sandoz’s tacrolimus, Salberg recalls, “I just felt different.” She knew her body, and she didn’t feel healthy.
Knowing the most reliable way to tell if the drug was getting into her system was through a blood test commonly used to measure tacrolimus levels, Salberg went ahead and got one without waiting for her doctor’s input.
The results validated her concern: The level of medication in her body was about half of what it should have been.
Her pharmacist suggested she call the transplant team to raise her dose, but Salberg insisted that taking more of the drug was unreasonable. She was taking the same dose of tacrolimus from Sandoz as she had previously taken from Accord. The drugs should have had the same treatment effect.
After finally being given a drug made by a third manufacturer, her blood levels returned to normal, and she felt better.
(Editor’s note: In 2023, the FDA found that Accord’s tacrolimus may have delivered higher-than-expected drug concentrations compared to the branded version it was meant to replicate, possibly explaining the drop in Salberg’s levels when she switched to Sandoz. It remains unclear how closely the third product matched the brand-name drug or why it ultimately worked for her.)
Salberg’s experience isn’t unique — others have also reported that medications meant to be interchangeable can have noticeably different effects on their health.
People living with ADHD have been one of the most outspoken groups, as recent drug shortages have left many of them taking medications made by different manufacturers every time they refill their prescriptions. Chemical analyses have shown that some of these generic medications dissolve at different rates — providing inconsistent doses — or can contain contaminants that might cause side effects or health risks.
Physicians have also been raising the alarm. Some advocates, such as Harry Lever, M.D., a now-retired cardiologist and former Medical Director of the Hypertrophic Cardiomyopathy Center at the Cleveland Clinic, have been speaking out for decades about the fact that the drug manufacturing industry needs better oversight.
The U.S. government, too, has raised concerns. As early as 1998, the U.S. General Accounting Office, now known as the Government Accountability Office (GAO) warned about the country’s inability to guarantee the quality of medications.
Generic drugs are required by the FDA to be fully interchangeable with their brand-name counterparts. But the more MedShadow investigated, the more it became clear: that’s not always the case. And what makes matters even more complicated: Despite all the aforementioned problems with generic medications, many studies continue to suggest there’s very little difference between brand-name and generic drugs.
Here’s how we got here, and what experts believe we can do to make the U.S. medication supply safer.
Generics are less expensive versions of brand-name drugs that are allowed on the market after the original drug’s period of exclusivity expires. A period of exclusivity is a timeframe set by the FDA to encourage pharmaceutical innovation by temporarily blocking competition.
According to the FDA, nine out of 10 prescriptions filled in the U.S. are for generic drugs.
Brand-name drugs typically require years of testing and substantial financial investment before receiving FDA approval. Once approved and released to market, companies generally set high prices for their medication in order to recoup their investment and make a profit. In 1984, Congress passed the Hatch-Waxman Amendments to promote competition and lower prices by allowing the FDA to approve generics without requiring full-scale clinical trials.
Instead of evaluating how well a drug treats an illness over time, generic manufacturers need to demonstrate only that their version of the drug meets specific criteria, such as having a similar dose of the active ingredients and being absorbed into the body at a comparable rate to the brand-name drug.
In some cases, the FDA may approve a generic based on data from as few as 12 test subjects.
This data is called an abbreviated new drug application (ANDA) and is sent by the manufacturer to the FDA.
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One permitted difference in generic drugs is the use of alternative inactive ingredients, as long as they’re deemed safe by federal regulators. Inactive ingredients are any part of a drug that is not expected to have a therapeutic effect. For example, they may be included to help the drug last longer on the shelf, taste different, or appear a certain color.
Once a manufacturer conducts tests to show its drug is similar enough to its target brand-name drug, the FDA will review its ANDA. If the agency believes the data is sufficient, it’ll declare that the drug is “bioequivalent,” meaning that it can be substituted for the original medication and be expected to have the same therapeutic effect.
If the FDA comes to believe a generic drug is no longer equivalent to the brand-name version — which can happen for a variety of reasons such as poor testing results after reports of side effects or because of new findings during an inspection — it can change its bioequivalence status in an online database called the Orange Book.
In this database, a column labeled “TE Code” stands for therapeutic equivalence. The TE code typically consists of two letters. If the first letter is “A,” the drug is considered equivalent to the brand-name version. If it begins with a “B,” it is not. (Additional letters may follow the A or B, but the first letter is the key indicator.)
Because a change of the TE code in the Orange Book is not considered an official FDA action, it does not, on its own, impact a pharmacy’s legal ability to distribute the drug, meaning you could still receive this drug at your pharmacy.
While the FDA has acknowledged specific instances where generic drugs were not the same as their branded counterparts, its official position remains that generic drugs are just as safe and effective overall as brand-name ones.
Still, bioequivalence statuses can change for a variety of reasons. In one recent case, the European Medicines Agency (Europe’s version of the FDA) found fraud in the data prepared by a contract research organization hired by many manufacturing companies to research generic drugs. In other situations, a manufacturer might use one formulation to get a drug approved but then fail to adhere to good manufacturing processes, leading to contamination or ineffective drugs.
In addition to identifying that Accord’s tacrolimus — the drug Salberg had been taking post transplant — was not releasing medication in the body at the same dose as the branded drug, the FDA has also found that some generic versions of extended-release Concerta, used to treat ADHD, were not dissolving at the same rate as the brand-name drug.
One reason it’s so difficult to hold manufacturers accountable for the quality of their drugs is that there can be many different laboratories involved in manufacturing a drug, whether brand-name or generic. The active pharmaceutical ingredient (API) is often produced in one lab, then shipped to another facility to be combined with inactive ingredients. From there, a different lab might apply the coating, and yet another might handle packaging and labeling. Yet only one of these companies will appear on your drug’s label — and in some cases, the seller can choose.
It’s similar to how a car might be assembled in the U.S. from parts manufactured in various countries, and still be labeled “made in the USA.”
Some pharmaceutical companies manufacture drugs — both branded and generic — in their own labs, but many contract with third-party laboratories to make the ingredients, medications, and packages. As of 2024, more than half of these for-hire laboratories are located overseas, primarily in India and China, where the medicines can be cheaply made.
In fact, according to a study from 2023, only 14% of generic active pharmaceutical ingredients (APIs) are manufactured by labs based in the U.S.
It’s important to clarify that the country where a drug is manufactured does not, on its own, determine its quality. Contaminated drugs have come from U.S. labs, and pure, effective drugs have come from labs in emerging economies.
However, drugs produced in emerging economies such as India have been linked in at least one study to higher rates of serious adverse events — including disability, hospitalization, and death — compared to those made in advanced economies like the U.S. The researchers specifically compared generic drugs made in India and the U.S. and found that those produced in India were 54% more likely to be associated with serious adverse events.
Both generic and brand-name drugs can be associated with quality issues that make them unsafe or ineffective.
They could contain the wrong dose of its active ingredient. They could be tainted with contaminants such as bacteria, heavy metals, carcinogens or other drugs. They could release their dose too quickly or too slowly in the body. The packaging may not be sufficient to keep the chemicals in the drug stable during long, hot shipping routes.
In April 2025, Salberg traveled to Washington D.C. to deliver a briefing on Capitol Hill highlighting problems with generic drug quality. With her were a group of advocates including David Light, a molecular biologist who co-founded Valisure, a company that chemically analyzes medications for large purchasing groups such as Kaiser Permanente and the Department of Defense (DoD), During the briefing, Light shared data from his team’s testing on tacrolimus, the drug Salberg takes to prevent her body from rejecting her transplanted heart, from 12 different manufacturers. Valisure found wide variability in how quickly the drugs dissolve in the body.
“Some generics were extremely different, dissolving over three times faster than the original brand,” notes Light.
According to his data, only four of the 12 drugs dissolved at the same rate or very close to the same rate as the generic brand.
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Salberg told the audience she wondered if having the drug dumped into her system too quickly meant that the dose didn’t last long enough, meaning she might have spent hours every day at risk of rejection. If the drug had failed, her immune system could have attacked the new heart, causing fatigue, shortness of breath, heart failure, and even death.
This kind of inconsistency isn’t just theoretical — it can have devastating consequences. In May 2024, Glenmark Pharmaceuticals, headquartered in Mumbai, India, recalled nearly 47 million doses of potassium chloride, used to treat low potassium that can be caused by dehydration from vomiting, diarrhea, or taking diuretic medications, because the tablets weren’t dissolving properly.
A federal lawsuit alleges that one woman went into cardiac arrest after unknowingly receiving a dangerously high dose due to the defect, dying shortly thereafter. According to ProPublica, a letter announcing the recall arrived three weeks after her death.
More than a decade ago, Dr. Harry Lever began warning patients and regulators about inconsistent drug quality. Now a member of MedShadow’s Health and Medical Advisory Panel, Dr. Lever says he began noticing that when his patients experienced a sudden decline in health, it often coincided with a switch from one manufacturer’s version of a medication to another’s. Sometimes, he could alleviate a patient’s problems if he could track down the drug made by the first manufacturer and switch the patient back to the one that had been working well for them.
Other doctors have also recognized problems with unreliable drug quality. Darin Okuda, M.D., a professor of neurology at UT Southwestern Medical Center in Dallas, noticed that several of his multiple sclerosis (MS) patients experienced significant flare-ups after switching from a brand-name drug to a generic version.
The FDA approved the first generic versions of Gilenya (fingolimod) in December of 2019, and over the past few years, many patients have been switched to the newer and less expensive generic drugs. Because insurance companies are allowed to decide which version of the drugs they will pay for, they will often refuse to cover the branded drug for most patients.
To investigate whether the change in medication could have caused the disease flares, Dr. Okuda recruited six patients who had made the switch and then had come in for regular follow-up appointments between January and August 2024. He and his team reviewed their records and chemically analyzed their medications.
In November 2024, Dr. Okuda published the results of his investigation. He found that those whose disease had remained stable had taken generic medications that contained 97.4% or 103.3% of the required dose of the active ingredient. Those who had had relapses of disease activity had been given generic pills that contained much less of the active ingredient: only 91.2%, 81.6% and 72.5% of the appropriate dose. [Editor’s note: Dr. Okuda receives research funding and consulting payments from companies that make brand-name MS drugs.]
Studies have also found differences in patient health outcomes from generic epilepsy and hypertension medications made by different manufacturers.
The full scope of the issue surrounding inconsistent dosing, dissolution, and purity of drugs remains unquantified.
The FDA’s job is to ensure that medications on the market are safe, effective, and are what the label says they are. However, the job is more complicated than many people realize.
The FDA aims to conduct routine inspections of drug manufacturing laboratories at least once every five years, where inspectors assess equipment, review protocols and documentation, and speak with staff to ensure compliance with safety and quality standards. In certain instances, an inspector might take samples of a drug for chemical analysis, but this is not part of a routine inspection, explains Patrick Stone, a former FDA lab inspector and current president of TradeStone QA, a company that helps drug companies prepare for inspections.
The inspector then writes up a report and makes suggestions for voluntary actions the laboratory might take to improve. If violations are particularly egregious, the FDA can issue a Warning Letter and put drugs on “import alert,” meaning that shipments from those companies would be stopped before they entered the U.S. market. You can find records of those inspections on the FDA’s data dashboard.
Documents from some of these inspections have revealed frightening scenes. In 2024, a Chinese company refused to share records with FDA inspectors. In 2022, when an inspector arrived at Intas Pharmaceuticals, a company that manufactures a variety of medications in Gujarat, India, an employee was found pouring acid into a trash can full of documents related to testing and quality control. In many more cases, inspectors have found poor recordkeeping practices, untrained employees, and equipment in need of maintenance and cleaning.
At a lab in Iowa that manufactures an over-the-counter drug, an inspector “observed a layer of dirt and a dead insect on the lid of [the] mixing tank that was only partially covered by a plastic sheet,” according to a Warning Letter issued in February 2025.
The FDA also monitors reports of side effects on its MedWatch database. Doctors, patients and family members can all report symptoms they suspect were caused by medications. If the FDA notices a cluster of problems coming from a particular drug, it’ll investigate. In some cases, the FDA will conduct chemical analysis of certain medications on the shelves, which can identify contaminants such as bacteria or other problems, and trigger recalls.
While the FDA is required to inspect drug manufacturing labs regularly, it currently lacks enough inspectors to adequately carry out that oversight. Although the agency has been focused on hiring more inspectors, a November 2024 report from the GAO points out that the agency continues to lose experienced inspectors to industry jobs with less travel and higher salaries faster than it can replace them.
“They’re losing inspectors, good inspectors,” says Stone. “So we’re going to see a lot less work getting done going forward, not more. That’s for sure. It takes a lot of training to get an inspector.”
Thousands of facilities have not been inspected in five years or longer, a span of time well beyond the FDA’s own benchmark for ensuring drug quality. As a result, the FDA has had to prioritize lab inspections that it deems high-risk and rely on partnerships with foreign health agencies to help uphold safety standards.
Moreover, because so many of these labs are overseas, inspections aren’t always as reliable as the agency would like. The inspector often gives the company up to 12 weeks of notice so that it can help facilitate the inspector’s international travel. This gives the company time to prepare and potentially hide evidence of poor practices.
“You have to schedule this three months in advance, so you’re going to clean up house if you know they’re coming,” says Salberg. “You know what happens when your in-laws come over for the holidays? You’ve got to clean everything, right? Same concept.”
Additionally, once he or she arrives, an inspector may need to work with a translator hired by the manufacturer to speak with employees, introducing the possibility that the translator could choose not to translate certain comments accurately to protect the company.
Advocates spoke to MedShadow about their ideas for improving medication safety in the U.S. The solutions are not exclusive to generic medications; they could apply to all drugs sold in the U.S.
Clearly, in order to be more proactive when it comes to medication safety, the FDA could recruit and hire more inspectors, pay more competitive rates (if the agency budget allows) to reduce the backlog of inspections, and do more to ensure laboratories manufacturing medications are using current good manufacturing practices (CGMP), requirements set by the FDA for laboratory cleanliness, recordkeeping, and the like.
However, at least one expert points out that catching up with the existing backlog would be a Herculean task. According to an AP investigation, the FDA is already behind by thousands of inspections.
“Because of the massive backlog that they’re facing, it would be very difficult to catch up,” says Eunjoo Pacifici, PharmD, Ph.D., an associate professor of regulatory and quality sciences at the University of Southern California. “It’s like a moving train. We can’t pause and catch up.”
The likelihood of catching up may get even slimmer as the current administration has cut 3,500 FDA staffers as of April 1, 2025. Senior FDA officials told CBS News that 170 of the laid-off individuals worked in the Office of Inspections and Investigations, and the agency has reportedly hired contractors to take over some of their work.
There are important steps you can take to protect yourself and your family.
Check your drug’s bioequivalence status regularly. If you’re taking a generic medication, you can periodically check its therapeutic equivalence status in the Orange Book. You may be able to find the drug’s manufacturer on the FDA dashboard, where you cansee when its facilities were last inspected and what the inspection results were.
Notice if the actual pills look different. If you go to pick up your prescription and the pills in the bottle look different, pay close attention to how you feel in the first few days of taking them. You should also check the manufacturer name on the label and see if it is different from your previous prescription. If you feel different, call your doctor or pharmacist to report your concerns..
Notice if the packaging has changed. If you go to pick up your prescription and your prescription packaging seems different, pay close attention to how you feel in the first few days. If you feel different, call your doctor or pharmacist.
Consider always keeping a journal of your symptoms and any side effects each day, including what medications you’re taking and who manufactures them (or if you don’t know who makes them, include details about what the medicine looks like.)
Report any new side effects or indications that your medicine isn’t working as it usually does to the FDA Adverse Event Reporting System (FAERS). The FDA monitors this database to identify new side effects or clusters of adverse effects linked to specific drugs.
Contact your local representatives, and tell them that transparency around generic manufacturing, ingredients, and potency are issues that matter to you.
Whether or not it was responding directly to the issue of the inspection backlog, on May 6, 2025, the FDA announced that it would conduct more unannounced inspections of overseas labs. “These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process,” notes the press release, providing little additional information on how the additional inspections will be achieved.
Stone has a measured response to the news. “This will help, but how many of them will they conduct?” he asks. “They conduct so few international inspections it will take years to catch up. Also, if we lose seasoned inspectors, it will take years for young auditors to be ready,”
Mariana Socal, M.D., PHD, associate professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, points out that the FDA is inspecting the same labs as foreign regulators, and notes that collaborating and sharing inspection results could lighten the load for everyone. A study she published in 2023 shows that while 86% of APIs were being manufactured overseas, the facilities that make them were often inspected by two global regulators. She explains that the U.S. has an agreement with the European Medicines Agency (EMA) to conduct inspections in Europe and share the results, but no such agreements exist with other countries.
Light and Randy Hatton, PharmD, a clinical professor of pharmaceutical outcomes and policy at the University of Florida, suggest that inspections are unlikely to ever be sufficient to maintain drug safety in the U.S. Instead, they suggest different ways of overhauling oversight.
Several groups are working to bring more drug manufacturing back to the U.S. In addition to simplifying lab inspections, doing so would better insulate the supply chain from geopolitical dynamics.
Early in 2025, Both Eli Lilly and Novartis announced plans to invest in domestic manufacturing. Several other drug companies also promised to invest in U.S. manufacturing to avoid tariffs. In a May 2025 executive order, President Trump directed the FDA and the Environmental Protection Agency (EPA) to review regulations and smooth the pathway for domestic manufacturing plants, which were previously estimated to take five to10 years to build.
Other companies are developing advanced manufacturing technologies that they say they’ll use to manufacture and test drugs for pharmaceutical companies in the U.S. MedShadow reached out to two such companies: Phlow and API Innovation Center, but has not yet received responses.
Drug packages are required to include the name and address of their manufacturer, packer, or distributor.
Since the label requires only one of these addresses and not all three, it can be difficult to get much information from them. If the package lists the manufacturer, you can look it up in the FDA’s database to see its inspection records, but if it lists the distributor, you’re out of luck. Even if a manufacturer is listed, you may not know if there were multiple factories in the supply chain.
During the April Capitol Hill Briefing, Salberg held up one of her bottles of medication. On a large screen, she zoomed in on the part of the label that denoted the drug’s manufacturer, Cipla USA. Then, she pointed out that despite the company’s name including “USA,” the drug was manufactured in India, a fact she’d discovered only after four hours of research and phone calls.
Dr. Hatton suggests that drug labels should include the name and geographic location of each facility in the process. He calls the approach “relatively painless,” and suggests that if people report adverse effects, problems could be traced back more quickly to specific manufacturing facilities where contamination or other issues may have occurred.
“There is no mandate that you would know where the active pharmaceutical ingredient, [or] where the actual finished dosage form [is] made,” says Dr. Hatton, adding, “if a patient were to experience an adverse drug event, it would be certainly helpful, from a transparency perspective, to be able to follow that product all the way back.”
In fact, John David Dingell Jr. (D-MI), Bart Stupak (D-MI), and Frank Pallone Jr.(D-NJ) proposed in the Food and Drug Administration Globalization Act of 2009 that drug manufacturers list the countries of origin of each ingredient in a drug on their website and be prepared to produce documents detailing the location of each step of the manufacturing process upon request, but the act was never passed.
As of 2025, a few other bills remain in the works, including the End Drug Shortages Act, proposed by Abigail Spanberger (D-VA), Adrian Smith (R-NE), Tim Kaine (D-VA) and Tom Cotton (R-AR), which would require drug manufacturers to notify the Secretary of Health and Human Services (HHS) of any impending drug shortage caused not only by an interruption in manufacturing but also by a surge in demand. The original law only required the companies to notify the secretary of an interruption or discontinuation in the drug’s manufacturing.
“Drug shortages can have tragic consequences for patients and force providers to ration life-saving medications,” notes Senator Kaine in a press release. “We must do more to ensure that Americans have access to the treatment they need.”
The bill was introduced in the House and referred to the Committee on Energy and Commerce in November of 2024 and simultaneously introduced in the Senate, where it was read twice, and referred to the committee on Health, Education, Labor, and Pensions. It has not made any further progress in either chamber.
Additionally, Section 744 of the National Defense Authorization Act (NDAA) for Fiscal Year 2025 asks the Secretary of Defense to develop a plan to strengthen domestic drug manufacturing and improve transparency around the production process — including where each step occurs and where potential risks lie.
Additionally, Senators Marco Rubio (R-FL) and Elizabeth Warren (D-MA) introduced an amendment in July 2024 requiring the Department of Defense to prioritize purchasing certain medications whose active pharmaceutical ingredients (APIs) are made either in the U.S. or in countries covered under the Trade Agreements Act, when available, but the amendment was not included in the final NDAA when it passed in December. (However, the bill could be reintroduced as a standalone bill in the future.)
Rubio, who has since been appointed Secretary of State, has declined to comment on the legislation. MedShadow also reached out to Warren and has not yet received a response.
According to David Light, the actions he’s taking with his company, Valisure, are a direct way to incentivize a complete market overhaul. Generic drugs exist to drive down the prices of medications. Because the FDA claims that generics are bioequivalent to brand-name medicines and we have limited information about the quality of the generics, companies are competing exclusively on price. That can lead to some manufacturers cutting corners to keep costs down, Light explains.
Light co-founded his company with his Yale University friend, Adam Clark-Joseph, who had long relied on anticonvulsant medication. Every so often, Clark-Joseph would experience sudden side effects and even seizures — episodes that typically persisted until his next refill. Puzzled, he asked his doctors why the medication seemed to work inconsistently. Their answer was unsettling: sometimes manufacturers produce “bad batches,” and there’s little doctors or pharmacists can do about it.
As the two dug deeper, they were stunned to learn just how little oversight exists. “No one is really checking the actual quality of the drugs,” Light told MedShadow. “The FDA checks paperwork and inspects facilities, but almost no one is chemically testing the pills themselves before they reach patients.”
From that conversation, the two launched Valisure, a company that set out to do exactly that: “The whole idea of Valisure was that we should check the chemistry of the drugs,” says Light.
Today, Valisure partners with Kaiser Permanente, the largest nonprofit, integrated healthcare provider in the US, which serves over 12 million patients and fills over 90 million prescriptions annually. For select medications, Kaiser now requires manufacturers to submit a sample from each batch for Valisure to test before finalizing the purchase. If a batch fails to meet Valisure’s quality standards, Kaiser rejects it and either requests a replacement or sources the drug from a different manufacturer. Tainted or ineffective medications are less likely to ever reach patients, and manufacturers may choose to improve their processes to maintain business from Kaiser.
Because Kaiser is such a large purchaser, the manufacturers are motivated to send their drugs for testing. “That’s an example of a solution that’s been hugely powerful,” says Light.
At first, Valisure tested only a small handful of the medications that Kaiser purchased, but over time, Light says they’ve started testing more and more drugs.
“I think what David is doing is brilliant. Absolutely brilliant. You test every batch,” says Salberg.
Not everyone has always been on board with what Valisure is aiming to do. The FDA has butted heads with the company on a few occasions, and in 2022, sent an untitled letter (a letter that describes potential regulatory violations but does not threaten any enforcement action) detailing the laboratory’s shortcomings, such as the fact that several employees logged into the company’s software using the same generic username, suggesting that there were no controls in place to prevent someone from deleting data.
Valisure responded to the letter, agreeing that the results of their tests cannot be used for regulatory purposes. Since then, Light says, “I think we’ve made progress in creating a more collaborative relationship with FDA.” In June 2024, Valisure met with senior leaders at the FDA to discuss analytical testing approaches and future work. In its 2025 analysis of ADHD medications, Valisure used the FDA’s suggested protocol for testing the drug’s dissolution rates.
Another example of chemical analysis in action is the University of Kentucky Drug Quality Study, which uses advanced scanning techniques to evaluate the contents of injectible drugs. It shares its findings with the FDA through the MedWatch reporting system. The program’s leaders described the work as, “putting puzzle pieces together and sharing the unfinished work with the FDA for their final determination given they have the remaining pieces from the original New Drug Application or Abbreviated New Drug Application (ANDA) files.” The screening results are also shared with the public through scientific publications.
In August of 2023, Valisure added the Department of Defense (DoD) to its list of high profile partners. The two entities are developing a scoring system for manufacturers of approximately 40 essential medications. The goal is to give purchasers a way to compare not just price, but also the likely quality of each drug when making buying decisions.
By testing samples from each manufacturer, Valisure assesses factors such as the dosage of active ingredients, how quickly the drug dissolves, and the presence of any contaminants.
Each manufacturer is then assigned a risk score, categorized into a simple three-color system: green for low risk, yellow for moderate risk, and red for high risk. This rating system gives the DoD a clearer way to compare drug quality, allowing it to weigh both safety and cost in its purchasing decisions. However, it doesn’t necessarily require Valisure to test every single batch of drugs delivered. As Light notes, price and quality often don’t align; in many cases, the cheapest drugs are among the highest in quality.
As an example, Light points to preliminary data on tests of metoprolol, a drug that lowers blood pressure and heart rate, made by 17 different manufacturers. His team scored two of the drugs “red” for high risk, seven “yellow” for moderate risk, and eight “green,” for low risk. In particular, his team highlighted the fact that much like tacrolimus, many of the drugs seemed to dissolve in the body much faster or slower than they were supposed to.
At the Capitol Hill Briefing, Light shared the results of tests his company had run on 99 manufacturers of six different drugs and said, “the good news is that two-thirds are green after a battery of tests.” But 11.6% of the six drugs tested for the DoD were given red ratings.
“There’s definitely interest in publishing and perhaps creating databases that these kinds of purchasers can interact with and having it all attached to the National Drug Code directory,” Light tells MedShadow.
Since pharmacies typically decide which medications to purchase and dispense, individuals have limited power to choose which drugs they pick up at their pharmacy. However, if consumers have a list of drug manufacturer choices, they could bring it to the pharmacy and ask if the pharmacy has a green one in stock. The pharmacy may tell them they’ll need to go elsewhere, but over time, if patients show pharmacists the ratings, they may be able to pressure them to purchase from higher-quality suppliers.
Light points out that the large purchasers, such as Kaiser and the DoD, are stakeholders who can “really help move the market” toward a model that encourages higher quality rather than just low prices.
The DoD has been funding its data collection project, but in the case of many pharmacies, Light says, the drug manufacturer would pay for the testing. He estimated that it could add about one to three percent to the overall cost of a drug.
“There’s been a lot of writing and a lot of discussion, but very little action. And it really takes congressional action for something, something to truly happen, in my opinion,” says Dr. Hatton. “There needs to be enough people drawing attention to this with their representatives, for representatives to want to do something about it right now.”
During closing speeches at the April 8 briefing at Capitol Hill, Salberg said, “I’m going to do something I don’t normally do. I will look right into the camera, and I am going to say to the leaders of this country, patients need you. We need access to care. We need safe drugs. We need you to focus on the needs of the citizens, and we need to make sure we’re not getting sicker from things that we’re paying money for.”
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Experts unpack what patients should know about generic drugs, quality concerns, and FDA oversight.
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