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.  

August Official Approvals and Receipts Released as OGD Approaches Record Year

The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday.  August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017.  These approvals are quite an accomplishment given the fact that the slowdown in the first few months of calendar year 2018 was so drastic.

No Easy Solutions for Complex Generics Yet

The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018.  In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as multiple sclerosis,

Reduced Testing, but Not Reduced Expectations

Reduced testing of Active Pharmaceutical Ingredients (API), excipients, and other raw materials can be a valid approach to gaining overall efficiencies in the pharmaceutical quality control laboratory.  However, the choice of tests to perform and the justification for choosing those tests are key elements of operating a compliant Reduced Testing Program that is also scientifically sound.

Bending, Breaking or Moving On: FDA Expands on its 2018 Compounding Policies Priorities

On September 7, 2018, FDA Commissioner Scott Gottlieb stated that the FDA will expand on their implementation of their 2018 Compounding Priorities Plan and that they feel like they must continue to balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could potentially cause harm to patients.

The Devil is in the Details:  Requirements for State Boards of Pharmacy under the Draft Standard MOU Regarding 503A Compounding and Intrastate and Interstate Distribution

The FDA estimates that the burden of information collection under their newly revised draft Memorandum of Understanding (MOU) (here) and reporting to the FDA to be about 7600 hours per year per state (assuming approximately 2000 work hours per year; this equates to about four new employees per year per state).  

Where There is Smoke, There is Fire!

The FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER), gave a presentation on April 12, 2016 entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.”  A key take-away from the presentation was that the Agency supports the development of drugs derived from marijuana (MJ).  This included mention of a guidance on the use of botanicals and the availability of Agency tools for expedited development (i.e.,

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.  

Fast, Fast, Fast, Everybody Wants Fast – But There Could be a High Cost to Pay

I know that the flag was raised in victory when the first generic of EpiPen was approved.  Not many people outside those familiar with the plight of complex generic products could understand how or why it took so long for a generic version of that product to make it through the approval process.  This is discussed in an interesting article by Avik Roya,

GDUFA and BsUFA User Fees – Time to pay the piper!

FDA’s User Fee Staff provided an overview of the progress and implementation of the first year of GDUFA II and BsUFA II user fees during the afternoon session of the second day of the GRx +Biosims Conference held at Baltimore, MD from September 5-7. The presentation recapped how the user fee structure for GDUFA II an BsUFA II changed,

Expedited Review, Priority Review, CTG – What’s the difference?

On the second day of the first annual 2018 GRx+Biosims Meeting in Baltimore, MD held from September 5-7, 2018, Kurt Karst, JD and Mark Schwartz, JD (Directors, Hyman, Phelps & McNamara, P.C) provided a very informative overview of cGMP trends and emerging legal issues concerning GDUFA and FDARA. The on-going modernization of the generic drug approval process has presented industry with new legal considerations.

The “Answer Key” for Inspection Site Selections

In a posting on FDA.gov yesterday, September 5, 2018, FDA Commission Scott Gottlieb, M.D., further reinforced his goals of an open and transparent FDA by publishing FDA’s internal policy on inspection site selections (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619435.htm).

The Center for Drug Evaluation and Research (CDER)  issued their internal policy Manual of Policies and Procedures (MAPP) 5014.1,

DI Still a Major Problem – but What’s Being Done About it?

The Association of Accessible Medicines (AAM) meeting in Baltimore this week saw a number of FDA presentations.  One that caught my attention was presented by Sarah Barkow, Ph.D., Acting Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing Quality in CDER.  It had to do with data integrity.

Dr. Barkow noted, “about 40% of OMQ’s warning letters include data integrity lapses.  

Facility Issues Sink Minor Amendment Designation

Historically, the Office of Generic Drugs (OGD) has classified major/minor amendments on the time necessary for review.  Minor amendments required minimal review, while major amendments required extensive review.  If there was an issue with a facility (e.g., cGMP), the old Deficiency Letters (DLs) and Complete Response Letters (CRLs) used to state that the firm should not respond to the letter until the facility issues have been resolved.