Over the last 50 years, companies have relied heavily on lawyers from big firms to review labels, advise on advertising compliance, interface with the FDA on their behalf, etc. Today, there are FDA regulatory consulting firms, like our firm, who market services that have historically been managed by law firms. So which option is best for your company? That ultimately depends on where you are, where you may end up, your budget, the scope of your project, etc.
Let’s face it – regulations in the US have been well established for over 20 years and the industry has now produced hundreds of professionals (plus former FDA officials) who have developed strong expertise in regulatory and legal matters, but who do not go to law school. The far majority of regulatory matters can easily be handled by an expert in regulations who does not work for a law firm. In some instances, it is more advantageous to utilize an industry professional over a lawyer. For example, you don’t want someone who has never worked in a manufacturing facility writing your standard operating procedures or quality programs. In areas like food safety and quality, industry best practices are as vital as what is written in the laws and regulations. You also don’t learn how to read, interpret and apply most food, beverage, OTC drug, and cosmetic regulations in law school (unless you participate in the Michigan State College of Law Global Food Law Program – shout out to my fellow Spartan graduates). These are all areas where lawyers can assist, but you will get equally valuable and accurate, if not more insightful input from industry professionals.
Now, don’t think I’m against lawyers – I’m definitely not. I have a masters in law and work with many well-respected lawyers on a regular basis. I worked in a law firm for 6 years and met many lawyers who were sharp as a tack when it came to regulatory matters. So where is a lawyer invaluable? If you are getting sued or are likely to be sued, you need a lawyer. I had a client one time who got a letter from the FTC, stating the FTC was investigating them for consumer fraud as part of a larger industry investigation. The client called me and I immediately referred him to a lawyer. Our firm could have helped him with part of the issue, but we knew he needed protection in the form of legal representation that we, at the time, couldn’t afford. I also have been involved in numerous lawsuits as an expert advisor or witness when the client simply needed lawyers to go into court and represent them, or the client was dabbling in an area where their exposure to private party litigation was too high (think proposition 65 violations). Lawyers should always be consulted in these areas.
Fast forward a few years and I’ve now partnered with a couple lawyers so our firm can now offer both industry regulatory expertise as well as formal legal advice/attorney-client privilege when needed. Ultimately, the industry needs both lawyers and industry professionals, but it is no longer necessary for companies to immediately turn to lawyers for many regulatory matters. If you get a warning letter from the FDA, if you need labels reviewed, or you are trying to determine whether your advertising complies with regulations, you can utilize either lawyers or regulatory experts. The options are vast in our current industry.
The most important thing to do is make sure whoever you consult has the expertise and background to best advise you in your area of need. Don’t be afraid to get references and quotes from both lawyers and regulatory consultants for your project. If a company or expert won’t give you a quote, won’t provide references, or insists you need a lawyer or regulatory expert and that the other won’t be able to help, you should probably go a different direction. If the cost seems too extravagant or you feel like you walked onto a used car lot when you speak with the expert, trust your gut. It is true that you will pay more for companies or individuals with proven expertise, so don’t necessarily jump to use the lowest cost option, but make sure you aren’t being overcharged ($1,000 for a typical label review in the US is WAY too much, unless you are hyperactive and demand immediate service, then you may be paying more in expedite fees than the actual label review fee – equally, $60 for a label is going to get you in trouble). Be diligent and get to know your potential advising partners, because that’s what you need – a partner. You wouldn’t trust your taxes to a college student fresh out of accounting 101, and you shouldn’t trust your brand with someone who doesn’t have the years of expertise you are seeking. Ultimately, you should find a partner whose primary goal is protecting your company and brand while helping you succeed.
So who should you use? That’s entirely up to you and your needs. Just realize there are options. Time taken to understand those options is nothing more than an investment in your success.