The Suit Magazine

McColl is a top-notch lawyer with Hyman, Phelps & McNamara, in Washington, D.C. With her dual expertise in pharmacology and law, she has made an indelible impression on the food and drug sector. The general public can recognize the fruits of her work in the widely used Dermabond brand, a medical product that helps to close wounds or incisions without stitching – a product for which McColl worked to earn regulatory approval. 
  Even as one of seventy attorneys in the firm, her combination of knowledge in the fields of pharmacology and law has set her apart. As an example of the work she does, McColl explained, “Europe is now struggling with how far you can go to describe a medical benefit. Health benefits advertised on food products must be backed by clinical data.” That’s where McColl comes in. “They need to demonstrate health benefits with clinical data. My pharmacy background helped me to understand the science and see how it fits into a legal regulatory framework,” she explained.   

McColl began her career by working in the field of pharmacology, satisfying a keen interest in biology. She had contemplated a hospital pharmacy position, “but it didn’t pay enough, so I worked for K-mart,” she laughs. But that didn’t satisfy her talents or her career goals. Displaying the intense resolve and adaptability that have served her well throughout her life, she made a bold move when she decided to go to the University ofSouthCarolina’sSchool of Law. With no money to pay for it, she simply “walked into the Dean’s office and asked, ‘How much do you want to pay me to go to school?’” she said. Eventually, she negotiated a scholarship and earned her law degree.
Since then, McColl has gained leagues of experience; she has grown adept at navigating within her areas of expertise – her ability to speak the language of scientists, the language of regulatory bureaucrats, and the language of the legal profession. 
At the beginning of her law career, McColl worked for Morlan, Lewin&Bancheu, where she was involved in trade regulation and anti-trust matters.  McColl took a liking to her work on the trade regulation side and decided she wanted “to be a food and drug lawyer.And I wanted to be with the people who knew more than I did, especially people with FDA experience,” she explained. 
McColl set her sights on a position with Hyman, Phelps & McNamara (HPM), but ended up finding a niche for herself at another firm. “Despite my pharmaceutical knowledge, I became involved one step back, working with chemical companies on due-diligence issues and transactional reviews,” McColl said. “I was involved with new drug development, but not on the pharmaceutical side.”
Nine years later, in 1989, McColl received a phone call from HPM.  She was offered a position and has been there ever since. It’s been a perfect match. “[Hyman, Phelps & McNamara] is the longest-standing non-European member of the European Food Law Association,” she told The Suit.
The firm has a vast network of resources at its disposal to supplement its combined knowledge. Working on sometimes complex or novel scientific regulatory issues, McColl and others work collaboratively with physicians and consultants who provide targeted medical or scientific expertise. Their clients may be looking to market their products, source ingredients or materials, or hold clinical trials. To its advantage, HPM has long-standing relationships with regulatory counsels in many foreign jurisdictions, including the European Union, Asia, Canada, Mexico, South America and Australia.    
In the field of food and drug regulation, new challenges are always arising. One of the emerging issues McColl has to grapple with is the increasing problem with “internet chatter about a product, bloggers talking about a product,” she said. In addition, she thinks a major issue facing the U.S. pharmaceutical industry is the concept of exclusivity.“Once a food additive is approved, anyone who meets certain qualifications can sell it,” she explained. “[In the U.S.,] you have exclusivity on the drug side; there is exclusivity before generic use. But you don’t have it on the food side, like in the United Kingdom. Exclusivity is an incentive [for a company] to research and develop a new food additive.”

Diane McColl approaches her work holistically, especially when negotiating tricky food regulatory issues. She envisions “a forum to encourage regulatory decision-making which involves a free exchange of ideas based on sound science.” Elected to the U.S.Pharmacopia’s Food Ingredients Expert Committee, which sets standards for the purity of food ingredients, she now has the opportunity to affect broader public policy and make even more of a difference.
 

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