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How to protect yourself and your company from “regulatory nightmares.”

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Dr. Richard Roberts

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without further ado tonight's guest richard h roberts md phd's a medical doctor doctor of biophysics and former pharmaceutical industry ceo for nearly a quarter century 25 nearly 25 years at url pharma tonight's show is all about in fact you know what earlier this week the wall street for those watching on youtube the wall street journal had a story in fact on their opinion page here it is biden gives regulators a free and heavy hand an entire column here and we thought of i mean who else than dr roberts who understands this unfortunately all too well he has stories on the front line so tonight's show is all about navigating regulatory issues some of the highlights what you need to know about regulatory nightmares and as dr roberts is going to explain many people out there going to think listen i don't have a company with with with a thousand employees how does it affect me well dr roberts is going to share that how you and your company can be protected and stories from the front lines with that intro a very warm welcome dr rich roberts thank you for joining me here once again on 710 wor thanks for having me back and that wall street journal article is very interesting so this is typical generally characteristic of a of a democratic administration that they're basically going to let the wolf pack out to go bite people so that's what we're going to discuss and how you can try to avoid getting bitten yeah so i our first my opening question is as follows what are regulatory authorities and why should it matter for our listening audience here in mind your business so regulatory authority is any of those government agencies that are going to interact with you if you are building a home it's going to be your local a building inspector your local construction inspector if you are an accountant it could be the irs if you're in a company it could be osha the department of labor and if you're in the pharmaceutical company if you have a pharmaceutical company it also includes the drug enforcement agency dea fda um federal trade commission doj they're all over you so um no matter who you are and at whatever level and whether you're own a business or not especially if you're in management or in a business but even those who work working um in a salary position and we're an hourly position i'm going to tell you how to keep yourself out of trouble now i'm i'm glad you're touching on this but if i may i'm just going to you know hold you to this because um many in the listening audience are probably thinking like i mentioned a few minutes ago i'm not running a major operation and i'm not running a pharmaceutical giant i'm running uh an operation i have 25 employees 50 employees i'm b to b i'm not b to c do do they do people like that also have to be concerned about regulatory authorities absolutely so here's the so these breakthroughs what i tell people is first of all there's no such thing as the government for you the government is the individual who's from the government is interacting with you you might happen to get a nice person who is really not out to get you not have to trick you um and is very reasonable but you might get someone who just wants to write up write up violations and you know so shoot first and yes questions later this is at all levels of any organization um so for example if if if the president of your company or if your manager and your worker tells you to do something that's illegal and they just tell it to you you know verbally you know quietly awaken and nod well if you go do that they can come after you the regulatory agencies law enforcement they can come hold you responsible they'll go after the manager also natural say i never told him to do that so one of the first things i want to tell you is get things in writing and before that i'll even tell you the snip test if something has a whiff of being off maybe not right and you're told to do something be courteous i'll be glad to do it to mr miss manager director vice president whatever just please send me an email not a piece of paper an email because emails are or basically forever you can delete the email off of his computer it's not off your computer you can both delete it it's on the server so make sure they give you an email and also uh if you knowingly do something that's wrong this they can still come after you that's the bad news the good news is um in life people only do what they're incentivized to do right now the incentive so what incentivizes a person in a regulatory department to come after you to write violations to or even worse going for prosecutions and that is what's going to help their career so so when you have a case like this where the president now says you know unleashes the dogs go get them you'll have um now regulatory agencies at all levels coming going to businesses and writing up violations now you have recourse which is i mean at the highest levels it's called the apa the administrative procedures act where you can actually sue the regulatory agency that can be if you think that they're they are citing you is are the words are arbitrary and capricious but by the time you get through the court system you'll probably be out of business or you'll be in jail and and it's too late it re it's not unless you're a huge huge corporation is probably really not going to protect you so um and the other thing you need to know is these regulations change so congress doesn't write all the detailed regulations congress will say to fda make sure that companies make sure that their products have had the integrity of quality purity and effectiveness but all the thousands of regulations as to how that's achieved are written by fda and they change they change over they could change over time without bettering warning what fda was doing for a long time i'm not running a company anymore so i don't know they're still doing it but what they did was they would do is called podium policy fda would give a speech at some industry conference on their new policy and then they send their inspectors out all over the country inspecting and citing companies for violations not having this new policy that they gave in a speech one example was going back many many years ago um they gave a speech that not only do you have to make your drug according to the the application that fda approved but you also have to check your raw material and control the particle size of particle size of little particles of the powder so they came in and cited us for that we're like what it's not in our fda approval to do this um it's not written anywhere they don't care they cite you for it violation um so so they are so generally regulatory agencies are incentivized to write up violations so at the end of the year they can show their boss or they can show the department they can show congress or they can show the township or the state look we my inspectors each found 2 500 violations they're saving everybody it doesn't matter if men if most of them are bogus that doesn't matter it doesn't matter if both of them are trivial doesn't matter i'll tell you something somebody you know was building building a building and the township um the township environmental inspector came over and cited them that they destroyed the greenery which could cause you know a rain runoff well of course they're constructing a building the grass was destroyed then half an hour later the county environmental protection guy came over and he cited the same violation why because the township guy and the county guy call each other they find something that could be written up see the other guy can come and write it up also the township level on the county level because they can both get it on their records this is how it really goes down so you know if you own a an accounting firm you might have osha come in and if there's a trash can in in you know in a hallway they'll cite you for it other they'll cite you for things that you don't even know existed so um it's a real it's a real danger but the regulations can change by the way like i'm amazed that many times police officers will stop people for speeding and after talking the person don't let them go well that's now a good person that someone's being nice but that's not generally what people in government are incentivized to do they're incentivized to write up violations that come after people so you need to number one make sure if you're told to do something that you think might not be proper if you even have like like an unconscious um you know width or a feeling just ask that the person told you to do it sends it to you by email and you see that first before you do it and you might even ask them my email back is this legal to do so that you're protected tonight's show is about navigating regulatory issues that's in the news these days the wall street journal had a column on it an opinion piece on it earlier this week and tonight's show is discussing a few important highlights what you need to know to avoid regulatory nightmares how to protect yourself and your company from regulatory issues and stories from the front lines we turn to dr roberts thank you again for joining us for joining us here on mind your business dr roberts yep no it's uh you always share so much and i get great feedback you know you help for the ratings i you know when i left 77 wabc my ratings i was up at number three and now i'm at or we got to get the ratings up so i say mikhail we have to get dr roberts on we got to get our ratings back up now now that we're talking about regulations i think it's either been passed you're going to be passed a 15 minimum wage you have to stop paying me six bucks an hour here ah you know last time you complained on the air that your check bounced i mean right did you redeposit it it should go through but yeah yeah mikhail we to give him a raise he did yeah yeah we got to give him raise he deserved the 15. has nothing to do with the federal regulation okay so dr roberts my question now and this is the question on everyone's mind how do i protect myself and or my company from the regulatory authorities okay so first of all there's no such thing as absolute protection because they're basically firing you know shots at you and all that you get to do is to try to duck them so there's there's no such thing as absolute protection as i say in america there's equal justice for all especially if you're wealthy so you know if they if they don't this for anybody if uh if a government decides to come after somebody you know let's say they charge somebody wrongfully with a crime though that person has to ask to sell their home saw everything they had to defend themselves they go on trial and they're found not guilty great they get paid back the money no they're broke they've lost their home lost their car have no money they're penniless so you know people who don't have the money to pay to spend on high-powered attorneys are more exposed than others the good that's the bad news the good news is when it comes to most regulatory authorities again what gives what what gets them promotions what gets those inspectors promotions and that's the big fish so they don't they don't get uh a big promotion over putting uh joe's pizza shop out of business but if they can go site you know a big a big pharmaceutical company big evil pharma and cite them with something go after them with a criminal you know charge that gets headlines that's what they like um they're not looking to you know generally not looking to bust the guy who's smoking a joint or or sporting a little cocaine but if they get the 200 million dollar cocaine warehouse bust they're taking pictures in front of the warehouse and they're they're taking pictures stepping one on the pile of money and the drugs so that's really what what they're motivated towards so that's at some degree protection now uh number one protection is do everything honestly don't cheat i'm serious about this be honest in business when you're making a lot of money this is easier to do when you're almost broke or you're in in real danger of a company going out of business that's when that's when the rubber meets the road that's when you get to show if you're really an honest person or not so do not get into that temptation um by the way there are companies that have been heading towards bankruptcy and the ceo the president believes that you know we could just get through this hump we're gonna we're gonna be okay so the money they would they were withholding from employees for the quarterly payments to the irs you know for taxes on wages they then take that money and use it in the business business goes bankrupt and they committed fraud um what you have to draw a line when things are not legal you simply can't do that don't do them whatever the consequences are look people you know accept rare cases or maybe you know someone is a schizophrenic living on the street people in america don't starve anymore uh whatever it is you have to go move in with your parents or a friend don't do something illegal that's number one number two not doing something illegal is not enough to protect yourself it's the unfortunate truth you need to dock if you're innocent and you're honest you need to document that you're innocent and honest and you can't document it when the inspectors come in with or the prosecutors come in you have to document it while it's happening and you documented by the email you can even send an email to yourself or you're sending it to other people not your lawyer it wasn't your lawyer because it's something called attorney-client privilege if you send your lawyer and they release that then they might break your privilege with a lawyer for everything to send someone else your company whatever it is to document that you're being honest um it's not enough to document this illegal thing is going on and i'm i'm not i'm not happy that i'm involved in it no no that's incriminated you but and don't do it don't do something illegal but you're doing things correctly you have to document that you're doing it when challenges come up and there's a temptation to do something the wrong way you have to document that you're doing the right the right way if there is that ever the worst case scenario which is a criminal prosecution all emails will show up every email will show up um everyone every single email okay you deleted it you didn't delete it they will all be they will show up and the opposing attorney the prosecutors they will try to take your words out of context so not only do you need to document you're doing things properly but you better document clearly and unambiguously in a way that people can't you have to think how could someone who wants to get me take these words and construe them a different way you have to always think about this everything will show up it will get everything we'll get every history of every telephone call um i'll tell you something happened in 1990 1992 i used to try to walk around the manufacturing plant and you know just walk into the the tabling department the lending department the pharmacy department with his scoop their own materials and just say to each employee i just try to do it like once a week shake their hand hi how are you as your family i once went into some guys some of the employees um rooms and tablet department and he said fda's in in the facility now what should i tell them if they asked me a question i said well you know tell them the truth but if you don't know the answer don't make something up tell them to speak to your supervisor then he said remember last month when he told me to lie to fda about this and this and this drug and i'm like i'm like what planet are we on so i think i said i don't know what you're talking about right i mean i didn't i got you right right right left field and then he said something something else and it was garbled on the tape and i said i just don't know what you're talking about and i left when i walked out in that room i thought could he be wearing a wire i said why would anybody want to be taping us right in library and why would the person be accusing you libel i mean and i s and i thought you know what maybe he's crazy maybe again i'm a physician maybe he's having a psychotic break or something maybe he's doing drugs i i don't know well don't you know that the department of justice showed up um about a year and a half later in the driveways of members of our management doing an investigation and this guy was wired by the by the fbi and that tape um almost everything else i mean i told everybody tell the truth do everything honestly but that take was what's called exculpatory evidence that means you get enough evidence that proves you're guilty that because i'm innocent right but but you have to be on your guard i mean i wouldn't i like what if you know where have i been reading a newspaper in my office and he came in and said this stuff and i'm saying yeah yeah yeah cause i'm not listening to him and i'm reading hey yeah yeah you go to prison for that you need to be really careful so number one do things honestly number two document that you do things honestly and number three be very very careful what you write and what you say because you never know if someone if someone is is is there as an agent or regulatory agency or they're trying to set you up for a lawsuit trying to claim that you're discriminating against people this way or that or whatever it is um you know as an orthodox jew you know what we believe is that god's always that's right that's right it's not when we're in the synagogue it's 24 24 7. that's right of course that was that was just running through my mind you know we're talking a business but at the end of the day we all answer to a higher authority one day and it's all these actions play out so you should live your life that way yeah but um just know that you need to always be careful you're getting a cup of coffee someone says something to you before you respond you better be not daydreaming because that can put you in a lot of trouble better focus on what they're saying very frightening yeah now if the government is not setting the regular regulators out to go get everybody then it's a more relaxed environment but you know if uh like happening now where the president is saying it's a regulator go get him uh you need to be on your toes for the remainder of the show we're basically going to be talking about or having asking dr roberts to share stories from the front lines and that includes uh converse stories that may have to do with the consumer product safety commission department of labor uh the dea the fda there's a tremendous world out there and like dr roberts shared at the beginning of the show every business there has some relation to some type of regulatory authority person someone out there like an accounting firm can't just say well what does the fda have to do with me there may be some uh outfits out there some companies that would have even a very limited exposure although as dr roberts said no one really is immune because of potentially some of the dealings that they that they're involved with he number one is that he shared always be honest and it may sound simple but of course it's so critical always be honest because you do that you're safe then he also said clearly document everything document everything preferably in an email because then it's there on some server somewhere dr roberts i hand it over to you stories from the front lines okay by the way one critical thing i left out was also if you have a regulatory problem you need to get an attorney or a law firm that specializes in that area of law there are tons of law firms they specialize in labor law or they specialize in fba regulations they specialize in dea and there must be others that specialize in you know in um yeah in construction whatever you're definitely in accounting so make sure you have a law firm that specializes in that area and if things start to get rough you don't blow your nose without checking with the lawyer first you don't write anything or say anything about checking the lawyer first okay uh i told you some stories that i could i could you know tell you from our my experience and what was the first one it was the osha and there was some super product safety commission yeah we we used to um before we began became a major manufacturer of drugs the company when i joined was mostly a distributor meaning we bought from other manufacturers and we put our label on it sold all over the place one of the products we sold was iron tablets people have iron deficiency anemia iron tablets are little red tablets they're sugar coated or sweet and unbeknownst to me there are some cases of children getting their hands on iron tablets young children toddlers and eating them and overdosing so so we got a let i got a letter from the consumer product safety commission stating that we sell iron tablets in bottles of 100 and it doesn't have a safety cap and if i don't put a safety cap on it and even with putting safety cap on i am now subject to a one million dollar fine and one year imprisonment for irons iron tablets like what i think i didn't know unfortunately the company is early on when i was there less sophisticated than we became didn't have much of a regulatory department at that point so it's crazy i mean so i immediately not right away like stop all sales of this should recall it should we not recall it get a lawyer forget what's going on and then and then we got well then until the manufacturer no more you have these safety caps on everything else and we did it after that we got so many heartbreaking letters from elderly people saying doctor says i need iron i have anemia but i have my arthritis my fingers are are you know all are painful and swollen i can't open the bottle so you're between a rock and a hard place yeah please please go back to your body i can't i can't that's your regulations working for you hmm between a rock and a hard place you're stuck you have no choice yeah you have to follow regulations another example before i get into some you know more juicy stuff yeah um when when the 9 11 attacks occurred meaning you know when the world trade centers were knocked down shortly after that there were anthrax attacks around the country right anthrax is a um is a uh is a microorganism that affects people and causes death very quickly from uh infecting the lungs and some powder was showing up in envelopes and places country is going wild the government couldn't find who was one or more people were perpetrating it they didn't know it turns out that there's an old antibiotic called doxycycline that treats anthrax and we happen to be one of the few manufacturers of doxycycline so we were able to sell and we're purely generic drug company at that time we made almost very little money almost nothing on some products even lost money believe it or not and we're selling you know most products look like two or three dollars for a bottle of 100 tablets made under under current good manufacturing practice standards all the science the technology behind it so uh so we're going to raise the price to make some profit on it um yeah it doesn't be unreasonable but once you have a chance to make some profit why not we got contacted by the from the fda object the department of human of health and human services as a as a group called the metropolitan rapid deployment force and they wanted to buy doxycycline from us at government prices which are so low there's no profit on it and they want to do it because they want to have hundreds of millions of tablets ready so that if this next anthrax attacks occurs the next anthrax attack occurs they can they can immediately ship this doxycycline into that and protect civilization right yeah so you know so um but we have to sell the government prices so i figured you know what i don't like it but uh but i don't like it because we're really struggling for money at this point but we're going to do our duty we'll give half of our production to them so we sell half of our production we got walgreens rite aid seagus everyone's screaming for doxycycline and was a note giving hamper production to the government wow even though of course with the drug stores with that whole day you could have made a profit decent profit yeah we could raise the price of a lot profit but we did our duty to help the governments we gave it to the government at basically zero problems then i get a letter from the department of labor now that you are a contractor for the government we're going to come out and inspect your affirmative action policy what because we gave up a profit opportunity to help the society and the government now we're gonna have an inspection point on a labor inspection i mean it's like no good deed goes unpunished now we had a perfectly good affirmative action policy and i personally made sure and i felt good about anybody was bringing themselves up from from like you know the lower socioeconomic economic background and their chance of promotion i personally got pleasure out of promoting those people the ones who performed and were good were loyal and capable and hard work but you know it's like this is crazy yeah so we got a lawyer got a law firm involved wrote a harsh-worded letter to the labor department and now the labor department was actually very reasonable this is again one of those rare cases where they're reasonable where where a regulatory agency is reasonable they said we understand the situation just have the just have the affirmative action policy on the desk we'll come in take a quick look and leave they've walked in the door they they opened up the policy bang bang they left no problem so they they they made up for it but it's like there's the regulations um no good deed goes on this is something that we i've seen repeatedly in life wow dr rich roberts medical doctor doctor of biophysics and former pharmaceutical industry ceo for nearly a quarter century he's going to share stories about interactions with the dea and fda dr roberts thank you so much for joining uh for joining me here on mind your business and for sharing of available time on such an important subject regulations on tonight's show thank you okay regarding the dea so we at our height manufactured about 2.4 billion tablets and capsules that's a b billion with a b a billion yeah billion 2.4 billion tables and capitals a year so there's a big operation and a lot of product moving through and and your batches and chemists and operators and machine operators everything's happening so i get a call from the dea drug enforcement agency and some of the products we made were narcotics one of this one in particular is acetaminophen with codeine or it's a tylenol with codeine some people might commonly know it as and it comes with 30 60 or 90 milligrams of codeine protein obviously is a narcotic i get a call from the dea you know dr roberts yes you're the ceo of the company yes you're responsible for those on the operations you know my antenna is going up yeah ultimately yes um we have an agents on the street that have been buying your tylenol for your your tylenol with potential codeine on the street we want you to get it stopped i said uh okay uh i don't i mean can you tell me who from the company is selling it i said we have hundreds of employees we're making billions of tablets a year can you just give me a little like clue no we can't tell you that well so you mean you want me to try to figure it out well how might the product be getting out well i don't know i mean i look you know the the operations are run by machine operators and they report to supervisors a report to managers the report to directors then in the case of operations report to the vice president and reports to me so i i don't know i said but i i don't it's going to be very difficult for us to find out who's doing this if you can't tell me the person's name just quiet quietly says okay i'm going to make up a name it's joe smith it's a joe smith are you kidding me he's like my friend out there he's a dallas cowboys fan and i'm a philadelphia eagles fan i go out there i jump with them all the time they say well let's in so give let me get back to you i'm going to look into this right away what's the next call to a law firm because i don't trust a government agency right you think they're working with you the next thing you know they accuse you of being involved in it so i get a law firm involved and a law firm contacted dea and i worked out a plan with a law firm and had a law firm communicate the dea this is our plan we're going to put in remote cameras in in in in the tablet machine area and um we're going to record when this guy is making a batch of that product and we coordinated with the dea so they were not agents there you know to look at the recordings of me as it was happening fine so i the only one i brought in from our company on this i didn't tell the chief financial officer i didn't tell the vp equality i told only the senior vp of operations what's going on and i told him go out and yell at your not yell at me but yeah not you know but it was show emphasis importance that we have customers for our acetaminophen with coding 90 90 milligrams and we have to get it of course we back in the batch records i found out that this guy joe is the one who made the fact who ran the talent machine for the last batch so i said go to your managers and tell them we got to get this done it's high priority and whoever was that ran the tablet machine last time you make sure that he that's the guy who runs the top of the machine this time because we've got to get this product done testing out the door great so then i found out the schedule tell somebody another law firm they told the dea and by the way those days we didn't have there's no wi-fi in those days so on a sunday afternoon i had a guy who did construction projects an external contractor come in and run over the drop ceiling we first we got first i engaged the detective agency which is ex secret service and fbi people and they give us little pinhole cameras and they they are one of my construction guys did was he he he burrowed out a little hole in the in the drop ceiling just a little pinhole little black panels all you could see and they ran the wires multipliers 150 feet from the manufacturing air across the office area to a closet mite in my office and then we had they were actually vhs those days you know tape recorders going and by the way as we did this surveillance trying to see if we could find somebody's feeling where it came to realize is when you do surveillance each machine is creating 24 hours of video a day right you have six machines you're thinking about 150 hours of video a day who's going to look at 150 hours of video right it's ridiculous so people i know concerned about the government watching them or whatever but there's so much data generated that's another story so fine so we got to got it it's happening 8 a.m thursday morning whatever it is so and i said i told the ladies from dea that the representatives should come and they come to the front desk they should sign in as representatives of acme chemical company right right son then i got a call dr roberts uh there's two men here from acme chemical company i said great send them in we have an appointment these guys come come to my front door one guy is like poorly dressed like pushy hair and a thick mustache smile the other guy is like five foot nine about 220 pounds solid bulging muscles he's got he has a a muscle shirt on his hair is shaven with only a little silver dollar sized amount of hair in the back that goes all the way down his back to his waist he walks and he says i know we look like scum but we're not i said oh no sir you look fine to me you look fine to me so close the door open up you know open up the you know the closet right with the monitor yep and now the the operator goes in the in the room he's about to start the batch and they say unit one to unit two we're starting who's unit two they have two agents in the parking lot watching this guy's car so as it starts up when you start manufacturing tablets the machines can run around 80 100 120 000 tablets per hour but until it gets going full speed the initial tablets to come out their weights are not stable right so you throw out spoilage right spoilage yeah yeah right if that's one or two percent of the tablets have to be thrown out every time you shut the machine out start it up again those those go to waste and anybody's wanting don't look in the trash can it goes to a regulated disposable waste okay so it starts up right away he opens up his lab coat and he pulls out this big bottle and he starts stuffing tablets in it and it's all there on video his customers must be back ordered also so then you see him put the bottle in in in in in his in his in his belt close up his thing and walk out of the room and then the one that de-agents gets on the radar he says unit one to unit two slam dunk slam dunk and then they go on to the information back and forth he's got the subjects going to his car open up the back seat remove something from underneath his tote he goes back a few times and then they said take them down i wasn't part of that they went out the manufacturing area but i heard that they they took this guy they slammed him against the wall and they searched him and that was that fine okay wow what a story there's actually only around three minutes left to the show so i'm going to ask perhaps you could even squeeze in one more story and then we're going to get to our new feature that we have and that is to share a business tip based on one of your initials or all of your initials it'll be up to you but we have around three minutes left doctor all right just briefly that story so this employee now we want to terminate his employment right right we germinate his employment and um and then he files for unemployment so i tell dea we want to deny unemployment because it's what's stealing drugs please give us a copy of our tape dee says we can't do that until we go through the whole prosecution process so here we are you're stuck you've got it right okay how do i get involved in politics i'm going to give a long story short and leave out a whole lot of things things i think are maybe interesting and entertaining but basically fda did inspections on us every six months for a year and a half to two years wrote up observations never called them violations never gave us drug approvals it was clear that these inspectors were trying to put us out of business so i figured we're here fda is here there's nothing we can do they wouldn't even return our calls we'd give them corrective action plans they wouldn't respond and just kept us with no approvals our profits are going down we're going to go out of business who's on top of fda and that's congress so i went to senator arlen specter who was chairman of the pennsylvania company who's chairman of the of the um the the committee in the senate that determines fda's budget and with the congressman jim greenwood who was chair who was also in our area chairman of the committee that deter in congress that determines fda's budget they both they write a letter to fda and say look we don't know quality or regulations but they're not even getting back to this company sounds like something's foul here right fba then came out and with a vicious inspection like we're gonna get them we'll show we'll show this company and it showed criminal violations for example well it showed that when you when you met when you manufactured pharmaceuticals your your air systems have to be pure hepa filters and you get work done in your ear system your quality department has to check the air systems before you manufacture drugs again so it said that we had our our hbac system worked on we then manufactured drugs and never checked the hvac system after his work done and we released millions of tablets to the public that's a criminal violation so i'm freaking out long story short we go through the documentation yes the hvac company came out that day but they fixed the refrigerator it's crazy and it was placed in the case of the case of that so i after working 16 hours a day for two weeks with the staff i contacted the the director of local fda and i told him i was freaking out but i'm seeing now what he's written here is false dr roberts he said it's a good thing he called me now and not three days from now that means that he they're going to have federal marshals come in and shut down the company and arrest people and so we we've been i would love to give the details we're out of time so sending that half two more weeks of work 16 hours a day for me six days a week just not the sabbath the stamp documents hundreds of pages and and i said you have ten days to get back to us before i'm going to show it to sender and congressman six days later hear nothing my director my vice president regular regulatory affairs calls the district office manager and she says fda's top priority is to give your company drug approvals wow then we've got trickle for everything to that what happened to the lead inspector who was fortunately trying to put us out of business she was promoted and shipped out tonight's show i can't we can't thank dr roberts enough uh you know when when when we saw the news coming out about regulatory issues we were scrambling okay who could we interview and and sure enough as anyone who um uh who was who was with us for the last hour understands clearly why we fought hard to get dr roberts on the show dr roberts before i let you go we have a new feature now that we're on 710 wor and that is that the guest shares in under 60 seconds a business tip based on any of their initials so you have rhr so um cue share a tip with the listeners of mind your business okay alright regulations hurt regular people at the end um you need to know so the the um the government's not going to go after the oil companies right since the new presence is in guess what's going to happen to your gasoline prices um the government's going to go if you're going to stop in the keystone pipeline so now the oil that the oil have to be shipped in by trucks polluting the air every i'm not saying all regulations are bad but but most economists many times say one of the key things to the booming economy that occurred under the trump administration that lifted everyone i mean black unemployment was the lowest it's ever been black employment was the highest it's ever been it lifted everybody and a major part of that was that that trump said okay if something's really a danger regulatory agencies go after him but no unleash the wolf pack so regular people get ready to pay higher prices for unnecessary regulations that's a sad truth thanks for watching if there are any other videos or topics you'd like me to address whether it's in medicine or science or business or other areas of life please just leave it in the comments i read every comment i try to reply to everyone and i really appreciate you watching please hit the subscribe button and please come back again i try to make videos once or twice a week all the best to you bye-bye