Ricki Chase Publishes Article in MedTech Insight

Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance and enforcement actions.

Get the Government into the Manufacture and Distribution of Generic Drugs – Who Thought This One Up?

It looks like Senator Elizabeth Warren thinks it is a good idea! (see here!)  I think it is poppycock!  Just think of the problems we have now with drug shortages and recalls.  The stringent nature of the cGMPs and pharmaceutical manufacturing, in my opinion, do not lend well to government intervention.  What a conflict of interest the FDA Office of Regulatory Affairs would have in inspecting the government manufacturing operations!

OGD Ties Its 128 Approval Actions Record in November Plus October Stat Update

It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions.  November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively).  The 128 total approval actions obviously ties last month record number of approval actions for a single month.

Of interest,

FDA Publishes a Bonanza of Regulatory Documents on Biotech Products – a Deeper Dive

Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week.  These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft,

FDA Withdraws Proposed Labeling Rule – Finally!

After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs.  The advance publication notice in the Federal Register can be found (here).  The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or warnings. 

Revision to Data Integrity Guidance Issues

Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here).  The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.”

The guidance does have additional examples and clarifying language. 

Q&A Document on the Transition of Certain Protein Products Approved Under Section 505 of the Act to Deemed Approved Licensed Product

Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more about the specific process and for answers to a number of questions.  FDA just issued a second revision of the question and answers document (here). 

FDA Revises 503B cGMP Guidance for Outsourcing Compounders

On Monday, the FDA revised the “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance” (here).  The initial draft guidance issued in 2014.

According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “[t]his revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.” The FR Notice also provides additional background on its thinking in making the revisions to the draft guidance.

November- Another Good Month

Dr. Kathleen (Cook) Uhl said there would be good months and not-so-good months. Well, although the official numbers for November are not yet posted, it looks like OGD will have another good month.  Not a record breaker, but close, unless there are at least 4 more not yet reported approval actions lurking somewhere in the IT reporting system. 

OGD Issues Guidance on Post-Complete Response Letter Meetings

The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings.  As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose questions to clarify identified deficiencies.  

22 New and 41 Revised BE Guidance Documents Posted!  AAM Continues to Voice Same Concerns

While we are thankful for the FDA’s work on issuing bioequivalence guidance documents, we worry about the impact of the constant and sometimes significant revisions to previously issued draft or final bioequivalence guidance recommendations on the review and approval process.  It seems that we are not alone!

In remarks made at the November 27th FDA meeting “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions”,

Did Someone Forget User Fees?

I just read the Association for Accessible Medicines’ (AAM) White Paper entitled “Ensuring the Future of Accessible Medicines in the U.S.,  Avoiding Shortages & Ensuring Competition for America’s Patients” (here) that is being entered into the record at the FDA-sponsored meeting  Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions held on November 27th in Washington DC.

Businessman Standing With A Target On His Back

Do Dietary Supplements Have a Target on Their Backs?

In a statement released by the FDA (here), the Agency cited warning letters to two “companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.”  The Agency noted that the ingredient has been the subject of numerous report of serious adverse drug events.