Treatment of Active Ingredients for Topical Administration
Section 6506 · Sec. 6506 ·
What this chapter is about
This part deals with drugs put on the skin, such as sunscreen. It tells the agency to accept evidence from real use. It also tells it to look at tests that do not use animals. And it sets terms for the sunscreen order.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6506 in the PDF
What the document says
“utilize standards that allow for the use of real world evidence (as defined in section 505F(b)), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials”
The section adds a new subsection (r) to section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h). The standards still have to let the Secretary weigh whether the benefits of an ingredient outweigh its risks.
What the document actually says
“utilize standards that allow for the use of real world evidence (as defined in section 505F(b)), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials”
That sentence, in plain words
The agency must use standards that let it count evidence from real use. That evidence adds to what trials show.
What this is about
Real world evidence comes from ordinary use, not a study. Many of these ingredients have been on sale for years. That record can now count.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6506 in the PDF
What the document says
“Not later than 1 year after the date of enactment of this subsection, the Secretary shall issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards under this section for drugs intended for topical administration.”
The same paragraph directs the Secretary to consider the kinds of nonclinical tests described in paragraphs (1) through (4) of the first subsection (z) of section 505, or any other alternative to animal testing the Secretary finds appropriate.
What the document actually says
“Not later than 1 year after the date of enactment of this subsection, the Secretary shall issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards under this section for drugs intended for topical administration.”
That sentence, in plain words
Within one year the agency must put out draft advice. The advice covers tests that do not use animals.
What this is about
Safety is often shown by testing on animals. Other methods now exist. This asks the agency to say how firms may use them.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6506 in the PDF
What the document says
“A final administrative order on nonprescription sunscreen active ingredients issued under section 3854 of the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116-136; 21 U.S.C. 360fff-3 note) shall-- (1) account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States;”
The order also has to account for the role of broad spectrum sunscreens with a sun protection factor of 15 or higher in effective skin cancer prevention, and to use the evidence and testing standards added by subsection (a).
What the document actually says
“A final administrative order on nonprescription sunscreen active ingredients issued under section 3854 of the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116-136; 21 U.S.C. 360fff-3 note) shall-- (1) account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States;”
That sentence, in plain words
The final order on sunscreen must look at old safety data. That data is on things already sold here.
What this is about
The agency has been working on a sunscreen rule for years. This sets three things the final rule must weigh.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The three duties the section creates: use of real world evidence, consideration of alternatives to animal testing with guidance within a year, and the terms the sunscreen order has to meet.
The clarification that the new subsection does not change the standards for whether a drug is generally recognized as safe and effective.
The section works by amending the Federal Food, Drug, and Cosmetic Act. That law is not indexed here, so this file does not say what the current evidence standards are.
