FDA Spotlights Drugmakers Who May Be Blocking Access to Generics

The Food and Drug Administration today announced new efforts to spotlight situations where drugmakers may be pursuing “gaming tactics” to delay generic competition. “Today, we’re making public a list of companies that have potentially been blocking access to the samples of their branded products,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval.” The information on the webpage includes, among other things, the brand drug company, the drug product and the number of inquiries FDA has received. “We’ll continue to look at more ways we can expand upon today’s action and call public attention to situations where the careful balance that Congress sought between product innovation and access may be being disrupted,” Gottlieb said.