To require an independent assessment of the Food and Drug Administration's review of drug applications.

1. Adds SEC. 7__. INDEPENDENT ASSESSMENT at the end of title VII

   Adds a section

   In S. 3187 · Placed on Calendar Senate

   Nothing in this title (or an amendment made by this title) shall be construed in a manner inconsistent with the obligations of the United States under the Agreement Establishing the World Trade Organization, or any other treaty or international agreement to which the United States is a party.

   Inserted: SEC. 7__. INDEPENDENT ASSESSMENT.

   Inserted: (a) In General.--The Secretary shall contract with a private, independent consulting firm capable of performing the technical analysis, management assessment, and program evaluation tasks required to conduct a comprehensive assessment of the process for the review of drug applications under subsections (b) and (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)) and subsections (a) and (k) of section 351 of the Public Health Service Act (42 U.S.C. 262(a), (k)). The assessment shall address the premarket review process of drugs by the Food and Drug Administration, using an assessment framework that draws from appropriate quality system standards, including management responsibility, documents controls and records management, and corrective and preventive action.

   Inserted: (b) Participation.--Representatives of the Food and Drug Administration and manufacturers of drugs subject to user fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall participate in a comprehensive assessment of the process for the review of drug applications under section 505 of the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act. The assessment shall be conducted in phases.

   Inserted: (c) First Contract.--The Secretary shall award the contract for the first assessment under this section not later than March 31, 2013. Such contractor shall evaluate the implementation of recommendations and publish a written assessment not later than February 1, 2016.

   Inserted: (d) Findings and Recommendations.--

   Inserted: (1) In general.--The Secretary shall publish the findings and recommendations under this section that are likely to have a significant impact on review times not later than 6 months after the contract is awarded. Final comprehensive findings and recommendations shall be published not later than 1 year after the contract is awarded.

   Inserted: (2) Implementation plan.--The Food and Drug Administration shall publish an implementation plan not later than 6 months after the date of receipt of each set of recommendation.

   Inserted: (e) Scope of Assessment.--The assessment under this section shall include the following:

   Inserted: (1) Identification of process improvements and best practices for conducting predictable, efficient, and consistent premarket reviews that meet regulatory review standards.

   Inserted: (2) Analysis of elements of the review process that consume or save time to facilitate a more efficient process. Such analysis shall include--

   Inserted: (A) consideration of root causes for inefficiencies that may affect review performance and total time to decision;

   Inserted: (B) recommended actions to correct any failures to meet user fee program goals; and

   Show 8 more inserted paragraphsShow less

   Inserted: (C) consideration of the impact of combination products on the review process.

   Inserted: (3) Assessment of methods and controls of the Food and Drug Administration for collecting and reporting information on premarket review process resource use and performance.

   Inserted: (4) Assessment of effectiveness of the reviewer training program of the Food and Drug Administration.

   Inserted: (5) Recommendations for ongoing periodic assessments and any additional, more detailed or focused assessments.

   Inserted: (f) Requirements.--The Secretary shall--

   Inserted: (1) analyze the recommendations for improvement opportunities identified in the assessment, develop and implement a corrective action plan, and ensure its effectiveness;

   Inserted: (2) incorporate the findings and recommendations of the contractors, as appropriate, into the management of the premarket review program of the Food and Drug Administration; and

   Inserted: (3) incorporate the results of the assessment in a Good Review Management Practices guidance document, which shall include initial and ongoing training of Food and Drug Administration staff, and periodic audits of compliance with the guidance.

   Original wording

   At the end of title VII, add the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed