Increasing Transparency in Generic Drug Applications
Section 6703 · Sec. 6703 ·
What this chapter is about
This part says the drug agency must tell a generic maker whether its drug matches the brand drug on inactive ingredients. If it does not match, the agency must say which ingredient is off and by how much. A match may not be taken back later, except in two cases. Guidance is due within one year.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6703 in the PDF
What the document says
“the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary's own initiative during the review of an abbreviated application under this subsection for such drug.”
Section 6703 adds a new subparagraph (H) to section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act. On request by a person who has submitted or intends to submit an abbreviated application for a drug required to have the same inactive ingredients in the same concentrations as the listed drug, or where the Secretary finds scientific justification for an in vitro approach to bioequivalence for such a drug, the Secretary must say whether the drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also volunteer that during review.
What the document actually says
“the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary's own initiative during the review of an abbreviated application under this subsection for such drug.”
That sentence, in plain words
The health chief must tell the maker whether its drug is the same as the brand drug. Same means the same parts in the same amounts.
What this is about
A generic must match the brand drug in its inactive parts. Those are the parts that carry the drug but do not treat. A maker cannot see the brand's recipe.
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. 6703 in the PDF
What the document says
“``(I) the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug; and
``(II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.”
Where the Secretary determines the drug is not qualitatively or quantitatively the same, the Secretary must identify and disclose to the person the ingredient or ingredients that make it different and, for any ingredient with a quantitative deviation, the amount of that deviation. This applies notwithstanding section 301(j) of that Act.
What the document actually says
“``(I) the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug; and
``(II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.”
That sentence, in plain words
Say which part or parts make the drug different. For any part off by an amount, say how far off it is.
What this is about
A plain no leaves the maker guessing. Naming the part and the gap lets it fix the recipe. It is told only what it needs.
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. 6703 in the PDF
What the document says
“the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless--”
Where the Secretary determines the drug is the same, that determination may not be changed or withdrawn after the abbreviated application is submitted, unless the listed drug's formulation has changed and the Secretary has found the prior formulation was withdrawn for reasons of safety or effectiveness, or the Secretary makes a written determination that an error has been identified. Where the second applies, the Secretary must give notice and a copy of the written determination to the requester.
What the document actually says
“the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless--”
That sentence, in plain words
Once the health chief says the drug is the same, that answer stands. It may be taken back only in the cases named next.
What this is about
A maker builds its plans on that answer. Pulling it back later would waste years of work. Two narrow exceptions remain.
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 “may not be construed”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6703 in the PDF
What the document says
“The disclosures authorized under clauses (i) and (ii) are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code.”
The new subparagraph states that the disclosures it authorizes are authorized by law, including for the trade secrets provision of title 18. It also states that the subparagraph is not otherwise to be read as authorizing disclosure of nonpublic information about a listed drug's ingredients, or as affecting the status of such information as a trade secret or confidential commercial information under section 301(j) of that Act, section 552 of title 5 or section 1905 of title 18.
What the document actually says
“The disclosures authorized under clauses (i) and (ii) are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code.”
That sentence, in plain words
What the health chief tells a maker under this part is allowed by law. That holds under the rule against giving away trade secrets.
What this is about
A brand recipe is a trade secret. Telling it out would normally be a crime. This carves out the narrow answers named above and nothing more.
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. 6703 in the PDF
What the document says
“Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.”
Subsection (b) of section 6703 requires the Secretary to issue or update draft guidance within one year of enactment on how the sameness determination will be made, including how pH adjusters are assessed, to allow at least 60 days for comment, and to publish final guidance within one year of the comment period closing. Subsection (c) provides that the new rule applies from enactment, whether or not the guidance is final.
What the document actually says
“Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.”
That sentence, in plain words
The new rule starts on the day this law passed. It does not wait for the guidance to be finished.
What this is about
Draft guidance is due within a year, with 60 days for comment. The final version comes a year after that. The rule runs the whole time.
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 main things the section does: require the Secretary to tell a requester whether the drug is qualitatively and quantitatively the same, require identification of the ingredients and deviations where it is not, bar changing a determination except in two cases and require notice where it is changed, state that the disclosures are authorized by law and what the subparagraph does not authorize, require draft and final guidance with a comment period, and set applicability at enactment.
Nothing else in the section.
The section amends the Federal Food, Drug, and Cosmetic Act, which is not indexed here, so what an abbreviated application involves is not recorded on this site.
