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,

Global Regulatory Harmonization for Biosimilars

The reinvention of the AAM’s Fall conference from The Fall Technical Conference to the GRx + Biosimilars Conference continues to be a success.  This year’s meeting included a very stimulating and informative agenda pertinent to generic drugs and biosimilar products.

On Monday morning, Suzette Kox, MSc, Pharm. Sec’y. Int’l. Generic and Biosimilar Medicines Association (IGBA) spoke on The Importance of Global Regulatory Harmonization for Biosimilars. 

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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,
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Drug Shortages Report Provides Look Forward

Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem.  Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy.  There has even been one firm created expressly to aid hospitals to avoid or resolve drug shortages.

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. 

Draft DMF Guidance Issued by FDA

A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989.  There have been many changes to the requirements and procedures for DMFs based on new laws, policies, and procedures, as well as procedures associated with GDUFA commitment letters for ANDAs,

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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,

Old Way x New Way Crossroad

Are All Methods Equivalent?

The use of alternate methods, especially for USP methods, some of which are rather old, has long been a question that both the industry and the FDA have contemplated.  Alternate methods can be easier to use and, in some instances, more accurate and reliable.  But how can you demonstrate that an alternate method is indeed equivalent to an existing method?

Just Say No! Not a Good Idea for a Testing Lab

In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory.  The FDA takes refusal of inspection very seriously and the impact on NDA or ANDA sponsors (or,

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New Fees Announced for Use of Priority-Review Vouchers

In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here).  Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for a specific drug or biologic that meets the regulatory and statutory provisions of the relevant acts,

Human resources restructuring process illustrated on blackboard

CDER Office of New Drugs Reorganization and Impact on OPQ and Office of Translational Sciences Announced

CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here).  The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise.  The FDA says, “the changes increase the number of OND offices that oversee our review divisions from six to eight—and increases the number of OND clinical divisions from our current 19 divisions to 27,

Petition Form

Revised 505(q) Petition Guidance Published

This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014.  The guidance document revision is based on comments that were submitted to the Agency after the original draft was introduced in 2018. 

Printout of a DNA sequence chromatogram

Extraneous Chromatographic Peaks – What’s a Lab to Do?

Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i].  This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations. 

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