Open Letter to the FDA: You’re Protecting the Wrong People

opinion

The FDA revealed on June 18, 2024, that an unnamed number of drugs on the market right now were approved based on potentially fraudulent testing and data.¹ This means there’s a risk that these medications may not be safe or effective. 

The name of the testing company that produced falsified data—Synapse Labs Pvt. Ltd. (Synapse) in Pune, India—was divulged by the FDA but not the names of the hundreds of drugs that were tested by them or, more specifically, the drugs for which data was found to be fake. Why? The agency said that information surrounding how, where, and by whom any drugs are tested is “confidential commercial information.” 

Are you shocked? I am. And I think we all should be. 

By withholding drug names, the FDA is saying that a pharmaceutical company’s right to confidentiality is more important than people’s safety. It’s protecting pharmaceutical companies’ trade secrets and reputations, while failing at its core mission: ensuring that all drugs sold in the United States are both safe and effective. As Diana Zuckerman, PhD, President of the National Center for Health Research, succinctly said: “This is an outrageous situation where companies are notified but patients aren’t.”

Not only are these drugs still on the market and able to be prescribed, the FDA is giving all companies who used Synapse Labs a full year to retest elsewhere and resubmit that new data in order to retain their approved status. 

Another disturbing fact: While most of the hundreds of drugs under question are generic versions of existing prescription drugs, some new drug applications incorporated Synapse-prepared (and potentially fraudulent) data. While there are ways for the consumer to check to see if generic drugs have been compromised—we’ll tell you how in the next section—it’s impossible for someone to check if a new drug was passed through based on faulty data. As a member of an FDA Advisory Committee that reviewed selected new drugs before the FDA approved or rejected them, I’m aghast to learn that the studies we were handed to review for new drugs may have been falsified!

Here’s How to Check If Your Drug Is Still Safe and Effective 

Unfortunately, MedShadow doesn’t know of any way to find out if the brand-name drug you are taking is one of the drugs in question. If you are concerned about the safety, efficacy, or side effects of any medication, it’s a good idea to consult your health care professional and your pharmacist. 

However, there are ways to check affected generic drugs. Generic drugs are an important part of the drug market, accounting for nine out of ten prescriptions filled.² Generic alternatives to brand-name drugs ensure competition that can lower the cost of drugs and limit shortages of medicines. 

The FDA reviews and potentially approves generic versions of a brand drug.³ Many drugs have multiple manufacturers–each with a slightly different generic version of the brand name drug–but all are deemed to be equivalent to the original in efficacy and safety. If, for any reason, the FDA no longer considers the data sufficient to determine whether the drug is equivalent to the original, it gives the drug a “BX” designation. You can call your pharmacist or doctor and ask if your generic’s therapeutic equivalent (TE) status has been changed to BX or you can look up your medications yourself here.⁴ To search for your specific drug, you’ll need the “applicant holder” (the manufacturer of your specific drug), which can be found on the bottle or packaging, often in fine print. 

But to be clear, you will not find a neat list that reveals the Synapse-tested drugs that may be falsified. You will find many drugs from years past that retain their generic designation from the FDA and other drugs from which the FDA has withdrawn or downgraded its equivalency designation, including some generic versions of Cialis (tadalafil), Viagra (sildenafil), and Lipitor (atorvastatin). 

The European Union decided to be more transparent than the FDA and published a list of generic drugs in question.^5,6 Anyone in the U.S. is free to explore it, too, of course, and I encourage you to do so. (Note, though, that drugs may have different names in Europe and the database is very difficult to navigate.) Unfortunately, the list is limited to generics.  

Do Generic Drugs Work and Are They Safe? 

According to the FDA website: “FDA’s review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs.”⁷

But this assurance to the American public is useless if doctors and patients can’t be sure these standards are enforced. In the case of generics, which are so prevalent, these must be equivalent to the brand-name drugs in dosage, effectiveness and safety. 

This matters enormously because if the contents of a drug don’t precisely match the listed ingredients, then the person taking that drug is at risk of: 

• Not receiving enough of the drug to be effective
• Taking in the drug at a level that could be toxic or harmful 
• Taking in ingredients not listed, potentially causing an allergic reaction or consuming ingredients that are not approved for human use  
• Taking in substitute ingredients that have a similar effect but are cheaper and potentially not indicated for your condition 

In database research done recently by Bloomberg, the media outlet speculated that generics for Cialis, Viagra, and Lipitor might have been in the fraudulent Synapse group because their therapeutic equivalence rating was changed during the window of time that fit the Synapse alert. 

An Urgent Call to Action for Drug Safety

Here at MedShadow, an independent nonprofit, we work to make sure that Americans are educated about, and can protect themselves from, harmful side effects of prescription drugs. This is hard enough to do when regulatory agencies are doing their jobs well. 

So I want to offer suggestions to help us all be safer while we wait for more meaningful action from the FDA.  Be extra vigilant about noticing any new reactions to any medication (generic or brand-name) you are taking. For example, if you’re on a blood pressure pill, take your pressure at home every few days to compare your readings to the past. High blood pressure can cause headaches and chest pain, while low blood pressure creates a risk of dizziness, falling and fainting. If your usual medication seems to be ineffective or creating bad outcomes, talk to your doctor right away. 

This Synapse fraud is a serious breach of public trust. It’s not just a case of a contractor not doing a good job, say, painting your living room. The FDA has our health in its hands. But now we are asked to accept fraud by a lab that claimed to be testing our medications. We have a right to know what we are putting into our bodies and the effect this may have as far as science knows. And we have a right to know it now. 

The FDA’s mission is simple and clear: all drugs need to be both safe and effective. Withdrawing drugs from the market that do not meet this standard may be difficult, but it must be done. Having served on the FDA Drug Safety and Risk Management Advisory Committee, I know that the FDA exists to protect the public, not the pharmaceutical companies. But now is a moment when the FDA needs to demonstrate that commitment with decisive action. 

 — Suzanne Robotti, Founder and President of MedShadow