Breakthrough medicines that could save lives may not reach patients as fast as possible, in part because FDA funding has been cut by $209 million — or more than 5 percent. That figure includes $85 million in user fees already paid by industry, but frozen by Congress.
Those affected are people who have run out of options for other treatments. There is a process to expedite FDA approval for breakthrough drugs. But because of sequester cuts, the FDA won’t have the staff resources to get the lifesaving drugs to patients.
This is government malpractice — every bit as deadly as the medical kind. Here’s why.
Last year, Congress passed a law creating a new FDA designation for “breakthrough” drugs to treat life-threatening diseases where “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.”