Replies to post #135027 on Biotech Values

[DewDiligence]

From the link you posted:

For ANDAs in the year 1 and 2 cohorts, FDA will expedite review of Paragraph IV applications that are submitted on the first day that any valid Paragraph IV application for the drug in question is submitted.

The vagueness of this statement does not instill confidence that P-IV challenges during the year-1 and year-2 cohorts (FY2013 and FY2014) will indeed be reviewed expeditiously. If they are not, then the stated goal for the year-3 cohort (ANDA’s submitted during FY2015) will apply, which is merely that 60% of ANDA’s be reviewed within 15 months.

All told, the stated goals for ANDA reviews in the FDA’s draft document are woefully inadequate, IMO.

[DewDiligence]

New head of FDA’s Office of Generic Drugs (OGD), Gregory Geba, was a mid-level executive at SNY:

http://www.drugstorenews.com/article/fda-appoints-new-generic-drugs-office-head

Odd choice, IMHO.

[DewDiligence]

Good news for generic-drug companies (maybe):

http://www.raps.org/regulatory-focus/news/2014/07/19794/FDA-Announces-New-Leadership-for-OGD-Super-Office/

The US Food and Drug Administration's long-awaited reorganization of its Office of Generic Drugs (OGD) is finally getting underway, the agency said in a statement today.

Since late 2012, FDA has been planning to elevate OGD to a so-called "Super Office"—an office which reports directly to the director of the Center for Drug Evaluation and Research, a position now held by longtime Director Janet Woodcock.

…FDA has announced that it has filled…four [OGD] offices with new leaders:

• Rob Lionberger, now acting deputy director for science, will lead the Office of Research and Standards (ORS), which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling.

• John Peters, now a supervisory medical officer, will lead the Office of Bioequivalence (OB), which includes the three Divisions of Bioequivalence and the Division of Clinical Review.

• Jason Woo, now the implementation manager for the Generic Drug User Fee Act (GDUFA), will lead the Office of Regulatory Operations (ORO), which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems.

• Keith Flanagan, regulatory counsel at OGD, will remain as transition lead for the Office of Generic Drug Policy (OGDP), which includes the Division of Policy Development and the Division of Legal and Regulatory Support.
…In a statement emailed to FDA staff, Woodcock conceded that the OGD reorganization had been a "long and arduous task" thus far, but that the benefits of the reorganization would benefit both FDA and the public in the coming years.

"The new structure will allow the Agency to conduct reviews of generic applications in a much more timely and effective manner while meeting GDUFA goals that become more rigorous and challenging each year," Woodcock wrote.

[DewDiligence]

Outcome metrics on current ANDAs and all ANDAs submitted since 10/1/12 (start of FDA’s FY2013):

http://www.raps.org/Regulatory-Focus/News/2016/05/02/24850/FDA-Slowly-Chips-Away-At-ANDA-Backlog/

Scan to Figure 2.

[DewDiligence]

GDUFA reauthorized for FY2018-FY2022; this is GPhA’s statement:

http://www.gphaonline.org/gpha-media/press/gpha-statement-on-the-generic-drug-user-fee-amendments

“GPhA and its members are pleased to conclude the first reauthorization negotiations to update the Generic Drug User Fee Amendments (GDUFA).

…Key provisions of GDUFA II include:

• GDUFA Backlog ANDA Provisions
• Priority and Standard Review
• Enhanced communication and transparency
• Complex Product Meetings
• Enhancements to the Inactive Ingredient Database (IID)
• Resource Management and Planning and Performance Reporting
• Small Business Relief

GPhA is optimistic that the provisions of this agreement will streamline approvals by assigning goal dates to all ANDAs to assure that no submissions from GDUFA I are left behind. It will also provide the FDA with additional resources, improving transparency and accountability in order to enhance the ability of the FDA to meet GDUFA II goals. Process changes and staff additions have been positive steps thus far, and the addition of enhanced performance reporting sets an even stronger foundation for translating FDA actions on generic applications to approvals.