Acetaminophen Back in the Spotlight, with Draft Guidance for Pediatric Liquid Products

With the FDA’s move to reduce the amount of acetaminophen (APAP) for prescription combination products to no more than 325mg per dosage unit completed, FDA seems to be moving into the Over-the-Counter (OTC) arena to help reduce potential overdose or medication errors with liquid APAP products targeted for pediatric patients. Today, FDA released the draft Guidance Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.

PQRI Presentation Provides Interesting Insights

In a September 17, 2014 presentation at the FDA/PQRI Conference on Evolving Product Quality given by Susan Rosencrance, Ph.D., Acting Deputy Director, Generic Drug Chemistry in the Office of Pharmaceutical Science at CDER, a number of interesting issues were presented and discussed. Some of these issues may be a welcome sign to the industry of a turnaround at OGD, but others still need some explaining.

GDUFA Policy Hearing – Where is the Silver in this Lining?

On September 17, 2014, FDA hosted the GDUFA Public Hearing on Policy Development. With quite a few generic firms of all sizes represented at the hearing, a series of recurring themes appeared to resound. Lack of communication and transparency from FDA and ever growing facility fees that stifle entry of small new players were the loudest complaints from the audience.

ANDA RTR Guidance Finalized with Some Important Changes – Issuance on Draft on Impurity RTR

n September 16, 2014, the Office of Generic Drugs (OGD) posted its final Guidance on Refuse-to-Receive (RTR) Standards and also published an ancillary draft Guidance entitled ANDA Submissions – Refuse To Receive Standards for Lack of Proper Justification of Impurity Limits (which explains that proper justification for specified identified impurities above qualification thresholds and specified unidentified impurities and unspecified [unknown] impurities with limits above identification thresholds must be included in the ANDA or it will receive an RTR letter).

Approvals Bounce Back at OGD in August; ANDA Submissions for the Month at a Tie for All Time Low

As FY 2014 draws to a close, the Office of Generic Drugs (OGD) has approved 45 ANDAs in August, the highest number for any month in this fiscal year, and through August 31 OGD has approved a total of 361 ANDAS thus far for this FY. In a repeat performance from last month, OGD reported receiving only 4 original ANDAs. Looks like firms are waiting for the October 1 to submit their ANDAs as the GDUFA metrics begin being applied to the cohort year 3 submissions.

GPhA Annual Cost Savings Report Shows Larger Savings for the US Public

The Congressional Budget Office (CBO) report last month indicated that the cost of health care programs has slowed sharply. A large part of the savings is attributed to the cost savings realized through the use of generic drugs. This year’s GPhA Cost Savings report showed that consumers (including the US Government) saved $239 million alone in 2013 an increase of 14% over the savings seen in 2012. The 10 year savings from generic availability is reported at $1.5 trillion over the last 10 year period.

Follow-up on Visible Particulate Matter in Parenteral Products

In a blog post on August 12, 2014, I raised the question of why there have been so many recalls of parenteral products related to visible particulate matter. There are a multitude of factors that lead to the formation of particulate matter, some of which have to do with formulation, some with storage, some with handling, some with manufacturing equipment and the like as was discussed in the blog referenced above.

New Paragraph IV Listings – Some Interesting Observations

The FDA’s paragraph IV (PIV) database is designed to give applicants and potential applicants information relative to first-to-file opportunities. FDA does this for two reasons: 1) it gives applicants assurance that their product is a first-to-file if the acknowledgement date (date acceptable for filing) on their letter from FDA officially receiving their application matches the date of submission in the PIV database. This has eliminated the many calls to the Office of Generic Drugs (OGD) to find out if their submitted application holds a potential first-to-file seat; 2) the listing also informs potential applicants that at least one ANDA has been submitted with a PIV certification and allows others to decide if they wish to enter the fray and expose themselves to litigation.

Despite FDA and Industry’s Efforts, Drug Shortages Continue

Over the last few days, FDA has posted information on new and updated drug shortages with 6 new shortages listed over the last week. We have noted the problems that drug shortages create in previous posts and we have all followed the media accounts of the problem; however, it still seems that, while many of the causes of drug shortages have been identified, stopping them from happening in the first place appears to be more elusive than any regulation, required notification or interaction with regulatory bodies can resolve.

Particulate Matter in Parenteral Products – Why So Much?

Last week while waiting for my flight home at an airport on the east coast, I decided to look at the recalls listed on the CDER web page. I realize that I have read about a number of recalls of parenteral products recently and those recalls were for a number of different firms, but what caught my attention was that 12 of 25 recalls listed were for visible particulate matter (including glass particles).
While I am not a manufacturing expert by any stretch of the imagination, I started to wonder why this might be.