Shame Letters from FDA- Will They Work?

The new Commissioner of FDA, Scott Gottlieb, M.D., has been moving very quickly since assuming his post. In a recent announcement reported by RAPS in its Regulatory Focus (here), he indicated FDA’s upcoming plans to “begin releasing letters that FDA sends to brand drug companies when generics question the agency on whether they should be able to obtain samples of the brand drugs necessary to produce generic versions.”

Many of these drugs are provided to patients through restricted distribution programs in which the drugs are sent from a specialty pharmacy directly to the patient. 

Will September Bring a Rush of ANDAs?

Remember when GDUFA I first started and there was a huge number of ANDAs submitted prior to the October 1 implementation date to avoid paying the ANDA fee?  Remember when OGD changed its stability requirement in June 2014 and there were 635 ANDAs submitted prior to the implementation of the new stability requirements?  Well, October 1,

Official August ANDA Approvals and Receipts Reported

We were close with our September 6th post (guess) but there were a few more approval actions reported in the official statistics that were released Friday September 8 in the afternoon.  OGD approved 60 ANDAs and tentatively approved 17 ANDAs for a total approvals action of 77.  There was also a spike in Complete Response Letters (CRLS) where OGD reported the issuance of 155 CRLs,

August Unofficial Approval Figures Not What Industry Had Hoped 

 

Looking at the FDA’s “All Approvals” list (here)  and slugging through supplements and originals for both ANDAs and NDAs, it looks like OGD efforts in August will yield about 57 approvals (the 7th lowest so far in the first 11 months of FY 2017). Also, though OGD tentatively approved (what looks to be like) 16 ANDAs for a total approvals action of 73,

OGD Delivers on First of Two Documents – Early!

Friday, September 1, 2017, the FDA issued MaPP 5200.14, a 43-page document that describes the Office of Generic Drugs’ internal policy and procedures for evaluating an ANDA for initial receipt as substantially complete for “receipt” (filing) purposes. We previously posted about this document here.

The MaPP also outlines the Refuse-to-Receive (RTR) limit on the types of deficiencies that will result in an RTR action,

FDA Ducks Question of the Running of 3-Year Exclusivity In Digoxin Petition Response

On August 30, 2017, the FDA responded to three older petitions all submitted by the same law firm relative to Digoxin products.  See FDA’s full response here.  The petitions addressed three basic issues: 1) 3-year Hatch-Waxman exclusivity; 2) bioequivalence requirements for this narrow therapeutic index drug; and 3) dissolution and blend uniformity requirements. 

How Robust are Your Data Review Procedures?

The ISPE has issued a GAMP: Records and Data Integrity guide which provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate and available throughout their lifecycle. A critical component of the data lifecycle is Data Review.

Data review should be based upon a thorough process which is defined within the procedure.

OGD Updates Workload Dashboard

On Friday. the Office of Generic Drugs released an updated version of its workload charts (here). Two of the charts are displayed below with explanation.

Total Original ANDA Workload Activity for Pre-GDUFA Year 3 Application Cohorts Thru 7/1/2017

This chart shows all pre-GDUFA year three applications (those before goal dates were assigned).

Industry Awaits Two Important OGD/OPQ Documents – Keep the Faith?

During the Hatch-Waxman meeting recently held at FDA headquarters, the new Commissioner alluded to two documents that he pledged would be issued hopefully by the end of this year.  One was a Good ANDA Assessment MaPP and the other a Good ANDA review Practices document.  In reviewing the history of the industry complaints regarding inconsistent reviews,

Don’t Guess Any Longer! Read the Guide on Ex-Date for Unit Dose Repackaged Products

For those of us that have been around a while and are well versed in the FDA’s expectations on repackaging of solid oral dosage forms into unit dose (UD) packaging, there is really nothing new in the recently published Guidance for Industry – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.  (see full guidance here). 

Child-Resistant Packaging – FDA Issues Labeling Guidance

The question of where, when, and how to label a product, whether it be a prescription drug, OTC product under an approved application, or an OTC product marketed under the monograph system has always been kind of a guessing game for manufacturers, packagers, and repackagers.  Now, a new Guidance titled “Child-Resistant Packaging Statements in Drug Product Labeling” answers many of those questions and provides guidance as to how to be in compliance with the FDA regulatory scheme.

User Fee Bills Need to be Paid but Reauthorization of User Fees Needs to be Passed – SOON!

FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures.  Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend the new money that comes in for the fees.