Gottlieb Tells Attendees at GRx-Biosims Conference About His Term as Commissioner

Dr. Scott Gottlieb is back in the private sector and took the time to give the attendees at the AAM conference a brief overview of his experience as Commissioner.  Dr. Gottlieb spoke about the creation of the Competition Action Plan which addressed action on the following issues:

  • Gaming the system through REMS and restricted distribution systems and patent issues
  • Devising a path forward for faster approval of complex generic drug products
  • Anticompetitive tactics

He also spoke about what,

Office of Compliance Reports Country Warning Letter Winner for 2019 Flip

Donald Ashley, JD, Director of the Office of Compliance at CDER reported a rather surprising statistic relative to the country that received the most warning letters in FY 2019!  And the winner is – the United States!  Domestic firms received 54 warning letters, followed by India with 17 and China with 14.  Previous years had India or China with the dubious distinction of being issued the most warning letters.

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AAM GRx-Biosims Meeting Day One Morning Highlights

The GRx-Biosims 2019 meeting started off with a meditation and stretching exercise; after that, we had to put our minds to work and begin exercising out neurons.  Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, provided an update on generic drug activity, action plans, and biosimilars.  Key points and highlights were:

  • Record breaking number of ANDA approvals in FY 2019 (935)
  • 125 first-time generic approvals
  • 138 approvals for complex generics
  • 205 product-specific guidances
  • The use of the Mutual Recognition Agreement with the EU on inspections designed to keep regulatory authorities from duplicating inspectional efforts
  • FDA has approved twenty-three biosimilars
  • However,

Revision to the Guidance “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017”

Today, the FDA issued Revision 1 to the above-referenced guidance.  According to the Federal Register notice announcing the availability of the revision, “[T]he draft guidance announced in this notice revises and replaces the draft guidance for industry on ‘Assessing User Fees under the Generic Drug User Fee Amendments of 2017.’  This draft guidance addresses changes in user fee assessments from GDUFA I,

Notice of Opportunity for Hearing Proposal to Withdraw Two ANDAs Implicates Cetero BE studies

In two separate Federal Register (FR) Notices on the FR prepublication page (here and here), the FDA proposed to withdraw approval of two ANDAs based on lack of confidence in the bioequivalence data contained in the applications.  The concern relates to a problem at a bioequivalence testing laboratory.  The Notices state:

“In May 2010 and December 2010,

Homeopathic Drugs Moving Closer to the Front Burner

The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products.  This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017.

Have Postmarketing Study Requirements? You May Want to Read This!

FDA published a revised draft guidance titled Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.  If you have any post approval study requirements for any of your products, you should pay close attention to this document.

In describing the document, the Agency says:

“This guidance describes FDA’s statutory authority to require certain postmarketing studies and clinical trials under section 505(o)(3) of the FD&C Act (i.e.,

Q&A Document Issued for Manufacturing Facility Information

The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc.

The document provides specific guidance on what, where, and how to list such information in the 356h and in the relevant modules of the application. 

First Official Metrics Out for September & OGD Smashes FY ANDA Approval Record – Could It Have Been Better?

For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in FY 2018. 

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New FDA Guidance on PDUFA Fee Waiver, Reductions, and Exemptions Issues

It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program.  The Federal Register Notice (here) announcing the availability of the guidance states:

“This guidance describes the types of waivers,

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California Governor Got it Wrong on Pay-for-Delay!

While California is usually a very progressive state, I believe that Governor Newsom did not quite understand the implications of the bill he signed into law banning pay-for delay patent settlements.  I believe he failed to see that not all pay-for-delay cases are anticompetitive.  According to the Association of Accessible Medicines (AAM) statement about the bill:

“As the Federal Trade Commission has found,

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OGD Updates August 2019 Metrics

August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications.  Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review applications submitted each month.