Ensuring Completion of Pediatric Study Requirements
Section 6602 · Sec. 6602 ·
What this chapter is about
This part opens up enforcement where a maker fails to do a required study in children. Action is now allowed, but only where the maker did not act with due diligence. Steps must be followed first, and a drug no longer sold is left alone.
The document says “is amended”Who acts: CongressHow: statuteSec. 6602 in the PDF
What the document says
“by striking ``(except that the drug or biological product shall not be subject to action under section 303)'' and inserting ``(except that the drug or biological product shall be subject to action under section 303 only if such person demonstrated a lack of due diligence in satisfying the applicable requirement)''; and”
Subsection (a) of section 6602 amends section 505B(d)(2) of the Federal Food, Drug, and Cosmetic Act. Where the old words shut off action under section 303 entirely, the new words allow it, but only where the person showed a lack of due diligence in meeting the requirement.
What the document actually says
“by striking ``(except that the drug or biological product shall not be subject to action under section 303)'' and inserting ``(except that the drug or biological product shall be subject to action under section 303 only if such person demonstrated a lack of due diligence in satisfying the applicable requirement)''; and”
That sentence, in plain words
Cross out the words that ruled out any action. Write in words that allow it, but only if the maker did not try hard enough.
What this is about
A maker can be told to test a drug in children. Before, missing that carried no penalty of this kind. Now it can, if the maker did not really try.
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 not”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6602 in the PDF
What the document says
“The Secretary shall not issue enforcement actions under section 303 for failures under this subsection in the case of a drug or biological product that is no longer marketed.''.”
Section 6602 adds a new paragraph (3) barring the Secretary from bringing enforcement actions under section 303 for these failures where the drug or biological product is no longer marketed.
What the document actually says
“The Secretary shall not issue enforcement actions under section 303 for failures under this subsection in the case of a drug or biological product that is no longer marketed.''.”
That sentence, in plain words
The health chief may not bring an action here if the drug is no longer sold.
What this is about
The point of the study is to guide use of a drug. If the drug is off the market, the study would guide nothing.
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. 6602 in the PDF
What the document says
“``(B) provide such person with a 45-day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph; and”
Subsection (b) of section 6602 adds a new paragraph (4). Before concluding that a person failed to meet a requirement, the Secretary must issue a noncompliance letter, give the person 45 days from receipt to respond in writing, and after reviewing the response decide whether the person showed a lack of due diligence.
What the document actually says
“``(B) provide such person with a 45-day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph; and”
That sentence, in plain words
The maker gets 45 days to answer in writing. The clock starts when the letter arrives.
What this is about
The health chief must send a letter first. Then comes the answer. Only after reading it can the chief find a failure.
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 “can”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6602 in the PDF
What the document says
“The Secretary of Health and Human Services may take enforcement action under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) only for failures described in section 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after the date that is 180 days after the date of enactment of this Act.”
Subsection (d) of section 6602 provides that the Secretary may take enforcement action only for failures occurring on or after 180 days from enactment. Subsection (c) makes a conforming amendment to section 303(f)(4)(A) of that Act, adding a reference to section 505B.
What the document actually says
“The Secretary of Health and Human Services may take enforcement action under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) only for failures described in section 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after the date that is 180 days after the date of enactment of this Act.”
That sentence, in plain words
The health chief may act on some failures only. They must happen 180 days after the day this law passed, or later.
What this is about
A new penalty should not reach back over old conduct. The 180 days give makers notice. After that the rule bites.
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 four things the section does: change the enforcement carve-out to a due diligence test, bar enforcement where the product is no longer marketed, set the steps the Secretary must take before finding a failure, and set a transition rule.
The mechanical amendments adding headings to two paragraphs and the conforming cross reference change in section 303(f)(4)(A).
The section amends the Federal Food, Drug, and Cosmetic Act, which is not indexed here, so what section 505B otherwise requires is not recorded on this site.
