FDA: Helping small businesses get big results

Small business has played a key role for growth and innovation in drug development, write Brenda Stodart, PharmD, Captain, U.S.

Small business has played a key role for growth and innovation in drug development, write Brenda Stodart, PharmD, Captain, U.S. Public Health Service, a program director at FDA's CDER Small Business and Industry Assistance Program, Division of Drug Information, and Renu Lal, PharmD, a pharmacist in FDA's Division of Drug Information, CDER Small Business and Industry Assistance Program. FDA data show that among the more than 2,100 new and generic drug applications submitted to the agency in 2014–15, at least 29% were submitted by small businesses, defined as those with fewer than 500 employees. According to Stodart and Lal, small companies "can be nimble with decision-making and can quickly progress with new ideas," and "a smaller drug development pipeline allows them to focus on a single or few products." They note, however, that "a small workforce tends to require employees to wear multiple hats, as opposed to their larger counterparts who typically employ teams of specialists. And because many small companies are focused on developing one drug at a time, they often operate on a 'high reward-high risk' model." To help level the playing field, FDA has been working to help small pharmaceutical firms maximize their opportunities for success. For example, FDA's Center for Drug Evaluation and Research Small Business and Industry Assistance holds several meetings a year as part of its Regulatory Education for Industry series of conferences. The meetings have significant international participation, either in-person or online, which is important, as about 80% of active pharmaceutical ingredients used in U.S.-manufactured drugs come from more than 150 countries. "At a time when quality manufacturing and the safety and effectiveness of drugs in development is as important as ever, CDER understands that providing support to small businesses through education and resources is vital to advancing innovation and protecting public health," Stodart and Lal conclude.