FDA Guidance and Opioid Cessation Unapproved Drugs

This week Hyman, Phelps, McNamara PC, in their FDA Law Blog, summarizes two recent FDA events, and provides some insights into their impact. I’ll provide a top line summary.  But you should read the the full articles if you want to understand the background.

Guidance on Guidance

• Essentially the FDA has issued guidance documents.

• Guidance is supposed to be just that guidance and not legally binding.

• However guidance has been cited as a reason in FDA Warning Letters, which makes guidance, tacitly, an enforceable regulation.

• Now theres some push back, the DOJ announced that it will prohibit DOJ from using its civil enforcement authority to convert other agency guidance documents into binding rules.

• That’s huge!!!   In short this suggests, that an agency can’t use a guidance document to create a new enforceable regulation!

Joint Action by FDA and FTC Against Companies Marketing Unapproved Opioid Cessation Products

• The FDA and the Federal Trade Commission (FTC)  jointly posted warning letters to 11 marketers and distributors of opioid cessation products.

• Releasing double-digit letters together emphasizes their seriousness of the issue.

• The FDA rules are clear, dietary supplements and homeopathic remedies, cannot make drug claims.

• A drug claim treats a disease. Per 21 CFR 109.93(g) a “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.”

• Opioid addiction is a  disease; and prevents the body from functioning properly (i.e. addiction is not normal)

• As such the 11 companies, are selling unapproved drugs. They have 15 days to respond.

As always please consult your attorney; this information is not intended as legal advice. Knowledge Bank is not a law firm nor do we provide legal advice.

Picture – Justice Department