Food and Drug Administration Commissioner Scott Gottlieb, MD, on Wednesday authored a blog post on the agency's website highlighting strategies to promote generic drug competition.
Here are four things to know.
1. In the last ten years, generic competition has saved the U.S. health system about $1.67 trillion, according to Dr. Gottlieb.
"We could see even greater cost savings if we helped more safe and effective generic drugs get to market sooner … by addressing some of the scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs," he wrote in the post.
2. Dr. Gottlieb acknowledged some branded drugmakers are taking advantage of FDA regulations to delay generic drug approvals and prevent competition.
"We are actively looking at ways our rules are being used and, in some cases, misused," he wrote.
3. The FDA will hold a public meeting July 18 to gain insight on which regulations and procedures complicate or delay generic drug approvals, according to Dr. Gottlieb.
4. Dr. Gottlieb said the FDA will consider policy and programmatic changes to boost generic competition independently and in collaboration with other federal agencies.
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