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,

BE Guidances Flying Off the Shelf – The Revisions Can Hit the Floor the Hardest!

Today, the FDA issued twenty-two new bioequivalence recommendations, some of which were for some fairly old products, including a couple of DESI drugs.  There were no surprises in the newly issued listings; however, as we have gone on about previously, the FDA has also issued fifty-two – yes, fifty-two – revisions to previously issued guidances. 

FDA Issues Guidance Document on CGT

Today, the FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” which describes the new statutory requirements under section 506H of the FDA Reauthorization Act of 2017 (FDARA).  CGT was enacted to promote and incentivize the development, expedite the review (and thus approval) of certain previously approved drugs with little or no competition.  In addition,

New OGD Director Named!

Today, the FDA announced the appointment of Sally Choe, PhD to succeed Kathleen (Cook) Uhl, M.D. as Director of the Office of Generic Drugs (Cook’s last day at OGD will be March 2).  Dr. Choe currently serves as Deputy Office Director, Office of Study Integrity and Surveillance within Office of Medical Products and Tobacco, Center for Drug Evaluation and Research,

OGD Has Another Banner Month on the Approvals Front – But Still No Word on Receipts!

OGD just released its official January approval figures and we nailed it in our previous post here, where it was reported that OGD would have 102 approval actions in January, despite the shutdown.  Well, we actually hit the nail on the head, as OGD did indeed break the 100-approval action mark by fully approving eighty-one ANDAs and tentatively approving twenty-one ANDAs.

Gottlieb Opens the Toolbox for Dietary Supplements – Beware the Hammer!

In our blog, over the years, we have addressed the issue of dietary supplements and some actions of bad actors relative to the chase for the almighty dollar.  Today, Commissioner Gottlieb announced the “agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight” (here) .

The Dietary Supplement Health and Education Act (DSHEA) was passed some 25 years ago and,

FDA 10th Annual Report on 505(q) Petitions and Stay of Action Petitions Released

Required by Section 914 of the Food and Drug Administration Amendments Act of 2007, the annual report of the impact of 505(q) petitions and petitions for stay of action issued this last Thursday.  This report discussed the number of such petition and describes any delays in approval that such petitions may have caused. The report covers FY 2017.

December OGD Stats Updated, but Still No ANDA Submission Data

As we previously reported here and here, December receipts are missing from the update, even though the rest of the December metrics have been updated (see below).  Well, they are not really missing (other than in the report), they just have not been figured out by FDA, due to the issues associated with the shutdown and the inability of FDA to collect user fees during the shutdown period. 

Piggy bank on money concept for business finance, investment and saving

AAM Annual Report on Generic Drug Savings Hits the Street

Each year, the Association for Accessible Medicines (AAM) publishes its report on generic drug savings (here).  The data is based on the independent IQVIA organization’s findings.  Some interesting findings in the forty-page report are outlined below:

  • 93% of generic prescriptions are filled at $20 or less.
  • The average co-pay of for a generic product covered by insurance is $6.06 compared to an average brand co-pay of $40.30.

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”,