3 Ways To Navigate Strict Legal Frameworks in Highly Regulated Industries
To deal with the strict regulations on companies like biopharmaceutical manufacturers, Dr. Sean Hall, MD, CEO of Medlab Clinical LTD offers a few tips
It can be a challenge navigating stringent regulatory environments, whether you're working to bring new pharmaceutical products to market or you operate a food manufacturing business. Generally speaking, highly regulated industries are so tightly controlled for the public good, either to protect consumer health and safety or to reduce the impact of vices on the broader society.
However, businesses working to operate in good faith in these spaces may sometimes feel suffocated by the rules set out by state or federal governments. Although many are devised with the best intentions, the result can be an inefficient, winding path to market — and in the case of publicly traded companies, it could result in wavering share prices and a loss of investor confidence.
To deal with the strict regulations on companies like biopharmaceutical manufacturers, Dr. Sean Hall, MD, CEO of Medlab Clinical LTD offered a few tips his organization has identified in working with regulators and developing a positive relationship.
Partner with the regulatory agencies
One of the most important steps to take when working in a highly regulated industry is to make friends with the regulators and support their mission. Whether you agree with the regulations or not, these agencies are dedicated to enforcing them, so it's best to accept it and establish a mutually beneficial relationship that shows them you're doing your best to play by the rules and be forthcoming.
"Regulatory agencies like the FDA or the TGA here in Australia are there to ensure the work we do is validated by a third party and approved as safe and effective for public consumption," Hall said. "We view it as complementary to our goal, even though it is a barrier that we have to pass through before our product can be sold. At the end of the day, we all want people to benefit from these medicines, and these regulatory approvals are part of how we ensure they will."
Viewing regulatory agencies as allies in getting a top-quality, reliable product to market in a way that protects consumer health and safety – rather than obstacles or enemies – can go a long way to easing tensions. Educating yourself as to their process and proactively meeting the requirements will also help to build regulators' confidence in your company.
Run unbiased tests and document detailed results
Establishing your own testing programs in an objective way and meticulously documenting data to demonstrate to regulators the sort of assurances they want to see can help streamline approval processes. For example, MedLab ran pre-clinical trials that offered clear insight into the consistency and efficacy of its pharmaceutical therapies for pain and stress management.
"We're working on establishing clinical data in patient groups that have been in the program from 2 months to 12 months, and we're one of the few companies out there that are actually collecting long-term data," Hall said, noting the company has 1,000 Australian patients under observation. "Having this data is helpful in convincing regulatory agencies like the FDA that our program is safe and effective, and it improves the odds that we expedite the approval process."
The trick here is to avoid putting your thumb on the scale. Regulators will easily sniff out any attempt to skew your data or bias your testing, and that will only reflect poorly on your company and hinder your chances at ultimately obtaining approval. Instead, set up your testing as you think a regulator would — really scrutinize your product to show them you're doing your due diligence to protect consumer health and safety while adhering to the regulatory framework. Besides, this type of rigorous testing only helps you develop a better product in the end, which will earn customer satisfaction and brand loyalty.
Clearly identify a target market and use cases that benefit society
Regulators want to understand the real-world impact your product is likely to have, so be clear and specific in identifying a target market. For MedLab, this has meant identifying niche use cases for their pharmaceutical products. While they know one of their therapeutics is effective for pain management, the data from their testing told them it was especially effective for bone pain in cancer patients — as a result, they've elected to start there.
"We actually see that our best responding group is cancer patients with bone pain, and this is a group of patients that, when you meet them, you really feel for them," Hall said. "We're also seeing promise in general cancer pain management as well. This would give doctors an opioid alternative to treat pain in these patients, and we might see fewer patients progress to opioids."
That ability to help make a broader impact on society is something regulators are sympathetic to, and if you have the early data to back it up your chance at receiving a fast-track designation increases, Hall said. For MedLab's stress management therapy, the company is similarly targeting a social phenomenon that has been compounded by the COVID-19 pandemic.
"The growth in occupational stress during the COVID-19 pandemic is really scary, and there's no therapeutic option currently," Hall said. "It's a growing concern and COVID-19 really showed how bad the problem is in terms of personal impacts, economic impacts, business impacts, impacts on relationships. There's no approved medicine for it now, but it's something we're working on here."
Know your audience — and work with them
Highly regulated industries such as the biopharmaceutical space are not easy to operate in. They can be costly, time-consuming, and there is no guarantee that the final products pass regulatory muster. Especially for publicly traded companies, this can take a toll on stock price and tank investor confidence.
However, by following the tips above, organizations from pharmaceutical companies to financial businesses can demonstrate to regulators they are making a good faith effort to be responsible stewards of their industries. While that might not always be enough to get every product across the line, it establishes a line of communication between business and regulator that creates room for honest feedback, improvement, and, ultimately, success.
"It doesn't have to be a fight, it can become something like teamwork," Hall said. "Regulations aren't going away and you have to learn to live with them, so make the regulatory agencies see that you want to do things the right way. Be forthcoming and transparent and give them access to all the information and then some that they need to do their jobs. When you do, watch how those doors begin to open."