Carter, Harshbarger call out FDA on DTE

A big APC thanks to Reps. Buddy Carter and Diana Harshbarger — we knew we had their support in the fight to get the FDA to reverse its decision on DTE, and now they’ve shown that support directly. They sent a joint letter to FDA Commissioner Marty Makary not just expressing their concern about the agency’s decision, but clearly explaining why it was wrong both scientifically and in terms of agency precedent: “By FDA’s own long-standing guidance, a drug product that contains a protein only as an inactive ingredient is not considered a ‘biological product’.”

And then they pointed out the practical side — that “This requirement is unworkable and could result in only one manufacturer achieving licensure, creating a monopoly, driving up costs, and jeopardizing supply.”

Combined with our ongoing, multi-pronged campaign to reverse the FDA’s decision (you are helping with that, right?) we’ve got a good feeling that the pressure will build and Makary and the agency will realize their mistake and reverse their decision … sooner rather than later.