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So your probably staring at this massive document demand from the FDA and your hands are literaly shaking. Maybe your drug manufacturing facility just got inspected and they found “issues.” Maybe someone reported adverse events from your dietary supplement. Or maybe your medical device has been linked to patient injuries and now there coming after you. Look, we get it. Your TERRIFIED. And honestly? You should be! Because FDA violations can mean criminal prosecution with up to 10 years in prison and fines reaching MILLIONS!
Let me tell you exactly what your facing when the FDA targets your business with a Civil Investigative Demand. The FDA has incredibly broad powers under the Federal Food, Drug, and Cosmetic Act to demand documents, inspect facilities, and gather evidence of violations – all without needing court approval first.
When FDA issues a CID, there not just looking at one issue. There gonna dig through everything: your manufacturing processes, quality control records, clinical trial data, adverse event reports, marketing materials, communications with healthcare providers, financial relationships with doctors, import/export documentation. Its a complete colonoscopy of your entire operation!
The really scary part? FDA investigations often run parallel with criminal investigations by there Office of Criminal Investigations (OCI). So while your responding to what seems like a “civil” investigation, your actualy providing evidence that could be used to prosecute you criminaly. We’ve seen executives go from thinking they were dealing with regulatory issues to being arrested by federal agents. Its absolutely INSANE how quickly things escalate!
Want to know the nightmare your facing? Let us break down the numbers that’ll make your stomach drop. Civil monetary penalties start at $10,000 to $20,000 per violation, but FDA routinely pursues multiple violations simultaneously. We’ve seen single warning letters cite 50+ violations – do the math!
But wait, it gets worse. If someone dies from your product? Criminal fines jump to $500,000 for corporations and $250,000 for individuals, plus up to 10 years in federal prison. And here’s what’s especialy terrifying – FDA uses the “responsible corporate officer doctrine” meaning executives can be held personaly liable even if they didn’t know about the violations!
Consent decrees are another nightmare. These court-enforced agreements can shut down your operations until you fix everything to FDA’s satisfaction. We had a client whose facility was shut down for 18 months under a consent decree – they lost $50 million in revenue and never recovered. The company that employed 200 people doesn’t exist anymore.
Your probably wondering “Why did FDA target me?” Let us tell you the most common triggers that put companies in FDA’s crosshairs.
Adverse event reports are huge – even a handful of serious adverse events can trigger a full investigation. And here’s the dirty secret: competitors often encourage patients to file adverse event reports about your products to trigger investigations. We’ve seen it happen dozens of times. Whistleblower complaints from employees are massive triggers, especialy since they can get rewards for reporting violations.
Failed inspections obviously trigger deeper investigations. But here’s what’s unfair – even if you pass an inspection, if the inspector doesn’t like something, they can still refer you for investigation. Import alerts for foreign manufacturers often lead to CIDs. Off-label promotion allegations are FDA’s favorite – they love going after companies for truthful speech about there own products!
Technically yes, but there’s some room to negotiate if you know what your doing. FDA’s CID probably demands an impossibly broad scope of documents going back years. While you can’t just refuse, we can strategicaly push back on certain requests.
The key is showing good faith cooperation while protecting your interests. We can argue that certain requests are overbroad, vague, or unduly burdensome. We can propose reasonable date limitations and phased productions. But you have to be careful – push too hard and FDA will think your hiding something terrible.
What really pisses us off is FDA often demands “all documents relating to” incredibly vague topics. How do you produce “all documents relating to quality”? Its designed to be impossible so they can claim you withheld documents later. We know how to handle these trap requests without falling into there games.
YES! Absolutley! FDA has multiple ways to effectively destroy your business, and they don’t hesitate to use them. Warning letters alone can devastate your reputation – they’re published online for everyone to see, including competitors, customers, and investors.
Import alerts can block all your products from entering the US market. For foreign manufacturers, this is basicaly a death sentence. Product seizures involve US Marshals physicaly taking your inventory – we’ve seen entire warehouses emptied. Injunctions can shut down production indefinitely until FDA is satisfied you’ve fixed everything.
The worst is when FDA refers your case for criminal prosecution. Nothing destroys a pharmaceutical or medical device company faster than executives being arrested. Stock prices crash, customers flee, employees quit. We’ve watched billion-dollar companies collapse within months of criminal charges.
This confuses alot of people, so let me explain the critical difference. A Warning Letter is FDA telling you they found violations and giving you a chance to fix them. Its public, embarassing, but not immediately catastrophic.
A Civil Investigative Demand is completely different – its FDA gathering evidence to build a case against you. Warning letters list known violations; CIDs are fishing expeditions to find violations. Warning letters give you time to respond; CIDs have strict deadlines with severe consequences for non-compliance.
Here’s the really scary part: getting a warning letter doesn’t mean you won’t also get a CID. In fact, if your response to a warning letter isn’t perfect, it often triggers a deeper investigation with a CID. We’ve seen companies think they resolved things with there warning letter response, only to get hit with a massive CID six months later.
Buckle up because your looking at months or years, not weeks. A typical FDA investigation timeline looks like this: Initial CID response (30-60 days), FDA review and follow-up requests (3-6 months), additional document demands (ongoing), witness interviews and depositions (6-12 months), FDA’s decision on enforcement action (12-18 months minimum).
During this entire time, your business is in limbo. You can’t get new product approvals. Investors won’t touch you. Partners distance themselves. Employees leave for more stable companies. Its death by a thousand cuts, and FDA knows it. They use the timeline pressure to force settlements on there terms.
The really frustrating part? FDA has no deadline to complete there investigation. We’ve seen investigations drag on for 3-4 years with periodic document requests keeping the pressure on. Meanwhile, your burning through hundreds of thousands in legal fees just to stay compliant with there demands.
Look, we’re not gonna sugarcoat this – trying to negotiate with FDA yourself is like performing surgery on yourself. You might think your being helpful and cooperative, but your probably making things worse.
FDA investigators are trained to extract information and admissions. Every conversation, every document you provide, every explanation you offer becomes potential evidence. We’ve seen well-meaning executives try to “explain” there way out of trouble, only to provide FDA with exactly what they needed for criminal referral.
The biggest mistake? Thinking you can charm or reason with FDA. These investigators have seen it all. Your not gonna convince them your violations weren’t serious. Your not gonna talk them out of enforcement action. What you will do is give them more ammunition to use against you.
This is FDA’s favorite weapon, and its absolutely RIDICULOUS. Off-label promotion investigations are where FDA goes after companies for telling the truth about there own products.
Here’s the insanity: doctors can prescribe drugs off-label all day long. Medical journals can discuss off-label uses. But if you, the manufacturer, share that same truthful information? That’s a federal crime! We’ve seen companies hit with billion-dollar penalties for sales reps mentioning published studies about off-label uses.
FDA’s interpretation keeps expanding too. Social media posts, scientific exchanges, even responding to unsolicited questions can be considered illegal promotion. They’ve even gone after companies for “liking” or retweeting third-party content about off-label uses. Its a complete violation of free speech, but FDA doesn’t care.
YES! And it happens way more often than you think. FDA’s Office of Criminal Investigations works hand-in-hand with the civil side. What starts as a regulatory issue can quickly become a criminal case.
The Park Doctrine is especialy terrifying – it holds corporate executives criminaly liable for violations they didn’t even know about! If your the CEO and someone in your company violated FDA regulations, YOU can go to prison. We’ve defended executives who hadn’t even been to the facility where violations occurred but still faced criminal charges.
Criminal penalties are severe: up to 1 year for misdemeanors, up to 3 years for felonies, up to 10 years if there’s intent to defraud, up to 20 years if someone’s injured, and life in prison if someone dies. Plus massive fines and permanent exclusion from the healthcare industry.
We’re not your typical regulatory lawyers who just shuffle papers and bill hours. We’re criminal defense attorneys who specialize in keeping executives out of federal prison when FDA investigations turn criminal. And trust us, they turn criminal more often than you’d think.
We know FDA’s playbook inside out. We know which violations they prosecute criminaly and which stay civil. We know how to respond to CIDs without providing ammunition for criminal charges. We know when cooperation helps and when it hurts. Most importantly, we know how to fight back when FDA overreaches – and they overreach ALOT.
Other firms will tell you to just cooperate fully and hope for the best. That’s exactly what FDA wants – an easy target who hands them everything they need. We take a different approach. We protect you from day one, challenge FDA’s authority when appropriate, and make them prove every allegation.
Call us RIGHT NOW at 212-300-5196
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Don’t make the mistake of thinking you can handle this yourself or that it’ll just go away. FDA investigations only get worse with time. Every day you delay is another day there building there case. The sooner we get involved, the better we can protect you.
Remember – FDA has unlimited resources and the full power of the federal government. There investigators, there lawyers, there scientists all working to build a case against you. You need someone equally aggressive and knowledgeable fighting for you. Call us NOW before this civil investigation becomes criminal charges!
Very diligent, organized associates; got my case dismissed. Hard working attorneys who can put up with your anxiousness. I was accused of robbing a gemstone dealer. Definitely A law group that lays out all possible options and best alternative routes. Recommended for sure.
- ROBIN, GUN CHARGES ROBIN
NJ CRIMINAL DEFENSE ATTORNEYS