The New Fee Paradigm of GDUFA II

As you are well aware, the negotiations for GDUFA II have culminated in the release of the new GDUFA II Goal Letter and has improved (at least on paper) the chances for additional improvement in the speed of generic drug approvals.  The initial overall baseline price tag for GDUFA II (starting on October 1, 2017) will be $493.6 million up from the initial $299 million based for GDUFA I. 

You Learn Something New Every Day!

The theme of Wednesday October 26, 2016 at the GPhA Fall Technical Conference was Patent and Exclusivity day (at least for part of the day) and in the category of “you learn something new every day!”, it was Pediatric Exclusivity that took the stage for me.  Turns out that, if you are an ANDA applicant and you file with a paragraph IV certification and you are not sued or if your suit is dismissed,

Comparability Protocols – One Age-Old Question Answered

Over the years I have been trying to convince firms that certain changes to approved ANDAs must always be filed as a Prior Approval Supplement (PAS) or, in some cases, these changes may be handled as a Comparability Protocol that is approved in an ANDA.  At the GPhA Fall Technical Conference yesterday, Dr. Lucinda (Cindy) Buhse,

FDA Plans to “NIPP” it in the BUD

The Office of Pharmaceutical Quality (OPQ) was launched in early 2015 with a slogan of “One Quality Voice”.  With Michael Kopcha, Ph.D., R.Ph. as the Director of the Office of Pharmaceutical Quality at CDER, and with approximately 1000 personnel in his group, OPQ’s objectives are as follows: a) streamline the regulatory processes and integrate major functional areas to facilitate a lifecycle approach to quality starting from pre-approval to post-product approval for branded and generic drug products;

OGD Director Provides Update on Generic Program at GPhA Fall Technical Conference

There is no doubt that the Office of Generic Drugs (OGD) is receiving more work than it anticipated under the negotiated GDUFA I program.  Dr. Kathleen (Cook) Uhl, Director OGD, noted that OGD received over 5 years of work in the first 4 years of GDUFA I, noting that the Agency anticipated receiving only about 750 ANDAs per year under the first 5 years of the program,

Who you Gonna Call . . . . to Resolve a Compliance Status Block on Approval?

This blog post was coauthored by Kurt Karst, Director, Hyman, Phelps and McNamara

If there’s something strange in your neighborhood; Who you gonna call?  If there’s something weird, and it don’t look good; Who you gonna call?  Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange or weird compliance-wise going on in your neighborhood that’s holding up final ANDA (or 505(b)(2) NDA) approval. 

What is Driving Industry Crazy Lately?

We asked around about what issues were driving firms crazy and these same three issues surfaced most often: 1) getting resolution of compliance status after inspection or re-inspection; 2) getting a straight answer from the Agency; and 3) what to do about maximum daily exposure issues relative to the Inactive Ingredient Database (IID).

Taking each issue in order:

Resolution of Compliance Status

Most of the compliance issues we hear about are after a firm’s inspection or re-inspection where the investigator tells the firm that there are no issues or where there is no 483 issued. 

Notice of Opportunity for Hearing Issued for Two Methylphenidate Generics to Concerta

Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets.  The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in the day than the reference listed drug product (and/or authorized generic). 

Compounding Pharmacies – Still in the Cross Hairs

Based on multiple FDA inspections and observations over many years, both brand pharma and generic companies have learned how to be better prepared for an FDA inspection and what to expect from an FDA inspection.  However, judging by the numerous Warning Letters that have been issued to Compounding Pharmacies in the last 2 years to 503A (43 total) and 503B (37 total),

Getting a CRISPR View – Genetic Editing: Medical Frontier

Most of us in the pharmaceutical industry have heard the phrase “targeted therapy”.  Targeted therapies are drugs or other substances specifically designed to prevent cancer cells from dividing or destroying them directly, and are intended to target only cancer cells.  While standard chemotherapy may affect all cells in the body (including healthy, non-cancerous tissue), targeted therapy uses drugs or other specially created substances (e.g.,

Final FY 2016 Approvals and Receipts for ANDAs Just Released

OGD’s final numbers for approvals and receipts and a few other metrics for the full FY 2016 were released today.  OGD approved 51 ANDAs in September for a total of 651 for FY 2016, an average of 54.25 ANDA a month. This represents the largest number of approvals in a fiscal year in (at least )the last 8 years (and likely longer) and is the most approved under GDUFA I (previous GDUFA high was 492 which was achieved in FY 2015 and 517 in FY 2012 prior to GDUFA). 

What Was Old is New Again

Thirty-six years ago as a young Pharmacy post-graduate, I was introduced to the “Continuous Process”. Merck commissioned the plant housing this process in the late 1970’s in the Shenandoah Valley of Virginia. Building on the company’s experience with continuous chemical processing, the plant manufactured a blockbuster (at the time) anti-hypertensive “Aldomet”, Methyldopa Tablets, USP. At the peak of production,

289 Pages of Pure Hatch-Waxman Joy

The FDA pre-published a Final Rule (here) today implementing Title XI of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003.  FDA has been regulating directly from the statute since 2003 and now (based on various court decisions and FDA’s experience) has finalized implementing regulations for portions of the Act some 13 years after passage.