Long Time Government/FDA Icon Bob West Passes Away

I woke up this morning to some sad news.  Bob West, former Public Health Service officer who spent some 40+ years in government service, passed away yesterday.  For those of you in the drug industry, the name Bob West meant a caring, rational, helpful individual.

Bob came to OGD after a stint with the Public Health Service’s hospitals and clinics and then after a number of years in New Drugs. 

Guidance on TA’ed Applications Deserves TA – Total Attention!

In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note:

“We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  

Big Year for NMEs at FDA

In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products.  All of the NME product approvals can be found here.

It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on the regulatory implications versus the practical implications of how the FDA is classifying this term. 

OGD November 2018 Stats Updated

Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions.

November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA.  The OGD acknowledged ninety ANDAs and of the ninety‑nine approved ANDAs in November,

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.

FDA Collection of Information FR Notice Provides Some Interesting Estimates

The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here).  The notice states that:

Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.  

Image representing statistics

2018 FY OGD Statistics Finalized

Late yesterday, the OGD finalized its 2018 statistical chart in its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance which can be found here.  There are some interesting figures and comparisons to previous years that are discussed below.

Let’s look at refuse-to-receive (RTR) actions to start.  FY 2018 saw the fewest RTRs since the start of GDUFA.

Metal clean shelves in market. 3d rendering

AG Epinephrine Autoinjectors get 2-Month Expiration Extension to Take Pressure off Interim Shortage

The FDA announced extended use dates for 72 lots of epinephrine autoinjectors.  All of the 72 lots can be used for 2 months past the labeled expiration date, according to stability data supplied by the company and reviewed by the Agency.   FDA noted in its announcement (here) that it does not expect or require the product to be relabeled with the revised expiration date,

In an Unusual Move, FDA Reopens Comment Period on BE guidance for Sucralfate Suspension

While the FDA does appear to listen rather intently to comments on its bioequivalence (BE) draft guidances, and will occasionally reopen comment periods, it is still the exception rather than the rule.  Today a Federal Register (FR) notice (here) announced another sixty-day comment period during which such comments will be entertained.

Verification Systems Under DSCSA Draft Guidance Issues

With many of the Drug Supply Chain Security Act (DSCSA) requirements coming upon the industry soon, the FDA’s issuance of the draft guidance document, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, discusses the verification process and expectations of the Agency relative to ensuring that products are legitimate under the DSCSA.

Hamster running on an exercise wheel

Controlled Correspondence Made Easier, But Watch Out

On October 1, 2018, the FDA opened a portal (here) that permits firms to submit Controlled Correspondence (CCs) directly and electronically to the FDA.  The process is further explained here, including how to register for use of the portal.  This could help speed CCs to the Agency, but it is the problem with what happens to some once they reach the Agency that has raised some industry eyebrows,

Female doctor sitting in her office and studying medical records. Medicine professional reading reports in clinic.

FDA Takes Action on Opioids – Approves Final REMS

Yesterday the FDA announced the approval of a final REMS “governing the use of immediate-release opioid analgesic medications.”  And the FDA did it in a big way, approving some 437 supplements for the various immediate-release opioid products.  The FDA stated in its new release (here):

This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals.  

Action shot of a cowboy riding a horse

Changes to Drug Substance Draft Guidance Come to Town!

The GDUFA II reauthorization process involved a lot of agreements from the FDA.  One of those agreements was for the Agency to publish a guidance on changes to drug substances that addressed the type of changes, their categories for submission (PAS, CBE, CBE-30, or annual report) and the necessary documentation that must be submitted to support the proposed changes.