FDA Annual Report Reviews Delays and Activity for 505(q) Petitions

The FDA has released its 2013 report to Congress regarding delays caused by 505(q) petitions. As most of you know, a 505(q) petition was created by Food and Drug Administration Amendments Act (FDAAA) of 2007 to require certain response times to petitions submitted to the FDA that would potentially delay the approval of a 505(j) or a 505(b)(2) application. Congress took this action because FDA response times to Citizen Petitions sometimes took years and industry complained that these delays in response caused delays in approvals for ANDA and (b)(2) applications.
FDA has done very well since the FDAAA in meeting the timeframes for response.

What Price Could the Public be Paying for the Slow Down in Generic Drug Approvals?

CBS Morning Rounds recently ran a piece on the soaring cost of certain generic drug prices. Despite the potential divisiveness of the topic, the piece was very balanced…The CBS piece cites potential reasons certain price increases have occurred as a decrease in the amount of competition for a particular drug product, temporary exit from the product market due to manufacturing problems, or decreases in the supply of active ingredients.

Rx vs OTC- the Debate Continues

On November 12, 2014, the FDA responded (here) to a September 23, 2014 correspondence to Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research and also submitted the same to Docket No. FDA-2012-P-0566 regarding the safety of PEG 3350 for pediatric patients. The big debate is a bit broader than just pediatric safety; it involves an Agency determination stating that, when a product is completely switched from prescription to OTC status,, the product can no longer be marketed by prescription.

Done and DUNS!

After years of FDA assigning unique establishment numbers to FDA inspected facilities, the Agency has published a procedural Guidance today entitled, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration: Guidance for Industry”, identifying their choice of the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet.

Office of Pharmaceutical Quality’s Office of Programs and Regulatory Operations – Wow, That’s a Mouthful!- But Get to Know Them

Remember when you only had to call to OGD to get ANDA statuses? Remember when these was a chemistry contact, a bioequivalence contact, a labeling contact, and a micro contact? Well, now, not only do you have to try to figure out who your contact is, but what you can all them about. The regulatory Project Manager in the Office of Generic Drugs is your primary point of contact for your ANDA. But now you also need to know who your “Quality” contact is in the Office of Pharmaceutical Quality’s (OPQ) Office of Programs and Regulatory Operations (OPRO). In addition, you need to learn a whole bunch of new acronyms!

MaPP to Nowhere to Get New Direction While Sparing on the GDUFA Goals Letter Continues

A number of presenters from Office of Generic Drugs (OGD) at the GPhA Fall Technical Workshop noted that “We have listened to what you have said and we hear you” and have indicated that MaPP 5200.3 that addressed communication with industry (see previous post here) will be revised. Industry representatives have indicated that the transparency in the communication with OGD is something that is essential to being able to make reasonable business decisions in a timely manner and are needed to appropriately run their business organization.

Woodcock, Cook and Yu Provide Views of CDER/GDUFA Implementation Movement

In a presentation to the Generic Pharmaceutical Association Fall Technical Workshop today, Dr. Janet Woodcock, Director, Center of Drug Evaluation and Research (CDER), told the audience that the new CDER quality initiatives under GDUFA are designed to have an Integrated team review to Chemistry Manufacturing and Controls, microbiology, dissolution and inspections through the new Office of Pharmaceutical Quality. The inclusion of dissolution review appears to remove that assessment from the bioequivalence review within the Office of Generic Drugs’ (OGD) team.

FDA Issues Final Guidance – Delaying, Denying, Limiting, or Refusing a Drug Inspection

On October 21, 2014, FDA announced the availability of its Final Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (here). This document finalizes Guidance that was published in draft for comment on July 12, 2013. The Guidance is intended to fulfill FDA’s obligation in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to define the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit inspection, actions that FDASIA established as causing drugs to be adulterated.

Six First to File Paragraph IV ANDAs Reported By OGD – But Where Are the Approvals?

The Office of Generic Drugs (OGD) listed 6 first-to-file (FTF) ANDAs with Paragraph IV (PIV) challenges yesterday. It is interesting to note that all were originally submitted in 2014-the oldest submission date was in April 2014 and the newest in July of this year. We know that OGD gives priority acceptance review to FTF ANDAs and the 2014 dates may signify that the priority acceptance review of PIV submissions is in full swing.

And Then There Were Three!

A day after writing a post about abuse-deterrent products and their potential impact on patients, the generic drug industry and the FDA, the Agency approved the third opioid extended-release product with abuse-deterrent information in its labeling approved via a supplemental new drug application, the drug Embeda (morphine sulfate/naltrexone hydrochloride) Extended-release Capsules.

Continued Complexity Of A High Profile CRO Data Integrity Case

While it is well recognized that any pharmaceutical company implicated with data integrity issues could have significant impact on its business and survivability, the impact from a similarly implicated CRO would be even greater as it could severely impact all sponsors’ pending and approved products. A case in point is Cetero/PRACS. Lachman Consultants was hired by a number of Cetero’s sponsors in support of these very labor intensive and highly specialized audits and (we are happy to say) successfully completed many audits for affected studies.