A burst of new federal rules regulating food manufacturing and medical devices is ushering in new business opportunities for law firms.
Loeb & Loeb, a Los Angeles-based law firm with about 300 attorneys in the United States and Asia, announced last week that it has created a new Food and Drug Administration regulatory group, led by Scott Liebman, a health-care compliance attorney. He will be based in Washington and New York.
It is Loeb & Loeb’s first attempt at formally building and expanding an FDA regulatory practice, an area that has been carved out by many large U.S. law firms, including Hogan Lovells, Covington & Burling and King & Spalding, and boutique law firms Olsson Frank Weeda Terman Matz and Hyman, and Phelps & McNamara.
Loeb & Loeb is not the only firm making moves to bulk up in food and drug law. Venable on Monday announced that it has added Heili Kim, a former regulatory lawyer at the FDA, to its Washington office.
Loeb & Loeb represents companies that are regulated by the FDA — including pharmaceutical, medical-device, and vitamin and supplement makers — as well as banks and private-equity firms that supply capital for them. The firm also represents e-commerce platforms, where the sale and distribution of FDA-regulated products is increasing exponentially.
“As that practice grows and thrives, the regulatory compliance element of the FDA has become more and more prominent in the representation of our clients,” said David Schaefer, deputy chairman of Loeb & Loeb.
The FDA has been tightening up the enforcement of food-safety laws, particularly since the Food Safety Modernization Act was signed into law in 2011, said Ivan Wasserman of Manatt Phelps & Phillips, an FDA attorney for
dietary-supplement makers. The law gives the FDA more authority in ordering product recalls and detaining products that it suspects are unsafe, and imposes stricter registration requirements for facilities that manufacture, process and pack food.
There are also several provisions in the Affordable Care Act that apply to medical-device manufacturers, and many in the technology industry are waiting to see what role the FDA will play in regulating mobile medical apps.
“There’s an enormous amount of new requirements and changes in the way manufacturers, whether they’re pharmaceuticals, medical devices or biotech, are going to conduct business,” Liebman said.
The changes are an opportunity for law firms to cash in on new legal work.
“There’s been a really sea change in how the FDA is going to regulate food manufacturing in the future,” Wasserman said. “As the new rules and regulations are implemented, companies are going to need a lot of regulatory assistance.”
Products regulated by the FDA represent about 25 percent of the U.S. economy, according to the agency’s estimate. Those products tend to be recession-proof — food, drugs and medical devices — and are prone to litigation, a major moneymaker for law firms.
“There’s been an explosion in class-action litigation with respect to food claims,” Wasserman said. “And on the drug side, the competition between generic drugs and innovator drugs on patents and FDA marketing authorities are high-ticket litigation.”