Compounder of Sterile Products Hit with Consent Decree

A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas.  According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products.  “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.  

Young african american man sitting on couch in modern apartment with mouth open, holding utility bill with high rates, raised eyeglasses in wow or surprise gesture

Commissioner Gottlieb Resigns – A Blow to the FDA and the Health of the Nation

In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation.  Dr. Gottlieb will stay in his position for about a month.  There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his taxing weekly commute to Bethesda/D.C.

Capsules in mortar

Final Guidance on Bulk Drugs that Can Be Used for Compounding for 503B Outsourcing Facilities

The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here).  After the posting of the draft guidance, the FDA says that it received approximately sixty comments from stakeholders and,

Continuous Manufacturing Guidance Issued by FDA – Can Generics Successfully Implement this Strategy?

Today, the FDA issued a guidance titled Quality Considerations for Continuous Manufacturing (here).  Talk about a controversial proposition!  The generic industry has long held that implementation of continuous manufacturing might not be appropriate for their business.  Why?  I am not always clear on the answer to that question, but change is always difficult,

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

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.

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.

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.

Annual Report on Postmarketing Requirements and Commitments Shows Continued Progress

Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications.  In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law.