The FDA recently came under scrutiny regarding their use of off-label promotions. The FDA can restrict the promotion of off-label products, but there is some questions as to what extent the FDA can do that. Certain scientific freedoms come under question when the FDA tries to restrict products that are not truthful and not misleading.
Key Takeaways:
- The US Food and Drug Administration (FDA) will hold a public hearing to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products.
- FDA has broad authority to proscribe the content of product labeling and impose restrictions on the off-label promotion of drugs, medical devices and other regulated products.
- How the agency should monitor off-label promotions and what actions it should take with respect to those that are false or misleading or otherwise raise public health issues.
“The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label promotions).”
