21 U.S.C. § 397 — Contracts for expert review
submitted 88 years ago by Pub. L. 105-115 to r/title-21-FOOD-AND-DRUGS · 358 words · no verdicts yet
The FDA can hire outside experts or organizations to review applications for approving or classifying products, including some biological products, to speed up or improve the review — as long as it doesn't hurt quality or unreasonably raise cost. FDA officials must still review the experts' recommendations themselves and make the final decision, within the normal legal deadline.
(a) The Secretary* may contract with an outside organization or individual with relevant expertise (who doesn't work for the Department*) to review part or all of an application asking the FDA to approve or classify a product — including applications under this chapter and biological product applications under the Public Health Service Act. The expert's job is to make recommendations to the Secretary. These contracts must follow the confidentiality rules in section 379 of this title. The Secretary may use this contracting power whenever it will make reviews faster, unless doing so would hurt review quality or unreasonably raise its cost; the Secretary may also use it whenever it will make reviews better, unless doing so would unreasonably raise cost. This can include bringing in extra scientific or technical expertise needed to evaluate new therapies and technologies.
(b) The FDA official responsible for the matter under review must look at the outside expert's recommendations and make the final decision in a timely manner. That final decision must still be made within whatever deadline the law otherwise sets for reviewing that kind of application.
The Secretary* may enter into a contract with any organization or any individual (who is not an employee of the Department*) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 379 of this title relating to the confidentiality of information.
The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.
Subject to paragraph (2), the official of the Food* and Drug* Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter in a timely manner.
A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this chapter or in the Public Health Service Act (42 U.S.C. 201 et seq.).
Source credit: (June 25, 1938, ch. 675, § 1007, formerly § 907, as added Pub. L. 105–115, title IV, § 415, Nov. 21, 1997, 111 Stat. 2377; renumbered § 1007, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)
- 1938Enacted · Pub. L. 105-115 · 111 Stat. 2377
- 2009Amended · Pub. L. 111-31 · 123 Stat. 1784
A history note hasn’t been published yet. The record shows enactment by Pub. L. 105-115 on 1938-06-25.
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