Pediatric Study Plan Guidance Updated by FDA

Today, FDA issued a revised draft Guidance document entitled, Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.  Quite a mouthful, but exceedingly important if you plan on submitting an NDA that is subject to PREA (Pediatric Research Equity Act).  Firms (of course) want to gain an additional 6-month extension on any existing exclusivity and have another 6-month period of protection,

TADs – Can OGD Meet the Aspirations of Industry?

The TADs, as described by Dr. “Cook” Uhl, OGD’s Director, are only aspirational in nature. This fact has been clear to the industry since the inception of the TAD program and their assignments. To be clear, industry is thankful for the TAD program and does understand the difference between GDUFA fixed goal dates and the aspirational TAD. But, in most instances, human nature has a way of looking for the positive in any situation and, in the case of TADs, industry must accept that their aspirations and the ability of OGD to meet these aspirational dates may not always intersect.

OGD February Original ANDA Receipts Are 2nd Highest in FY 2016

The yin and yang between approvals and receipts of original ANDAs is always a balance that the Office of Generic Drugs (OGD) must deal with, and OGD only has control of one of these metrics. The number of original ANDAs submitted in February was the second highest for FY 2016 with a total of 62 received. This pales in comparison with the December figure of 180, but is still indicative of the fact that OGD can expect more applications this year than last.

Cook Says FDA is Delivering at OGD Update During GPhA meeting

Dr. Kathleen “Cook” Uhl, Director of the Office of Generic Drugs provided an update on the progress of OGD in the implementation of GDUFA I.  Despite the “tension” and uncertainty noted by the panel that preceded her (see yesterday’s post), Cook delivered a strong message that OGD has meet all of its GDUFA goals to date and has gone above and beyond the goals outlined in the GDUFA goals letter.

Gottlieb Panel Feels the Tension with OGD

Scott Gottlieb, MD hosted a three-person panel on the closing day of the GPhA Annual Meeting just before Dr. “Cook” Uhl presented the Office of Generic Drug (OGD) update. Scott fired questions at Kate Beardsley (Beardsley Law PLLC), Sheldon Bradshaw (former Chief Counsel FDA and now a partner with Hunton and Williams LLP), and Frances Zipp, (President and CEO, Lachman Consultants).

FDA Finalizes Guidance on Low Molecular Weight Heparin Characterization and Immunogenicity Considerations

Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here).  The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products.  The document provides guidance for NDA holders (for new products or changes to existing products) and for ANDA applicants. 

More on the New Guidance Documents FDA Plans to Issue in 2016

On January 25, 2016, this blog posted an article about some of the Guidance documents that FDA was planning to issue as new and or revised this coming year (here).  In that blog post, it was noted that an update to that post would be coming-well here it is!

Some of the other notable documents we can all be looking for this year (with a little bit of editorializing) include,

Compounded Hormone Products Are a Big Business – Medical Groups Raise Concerns

According to a recent article in Medscape Medical News (here), the use of compounded hormone therapy to treat symptoms of menopause is a big business and accounts for a significant percentage of some compounding pharmacies income.  The article provides an estimate of $1.3 -1.6 billion annually.

With the flurry of FDA enforcement actions on pharmacy compounders,

If Wall Street and the Regulators Speak – Then Something is Likely to Happen!

I recently read a very interesting article about some big vitamin companies and their stock performance. I think that it deserves some attention because, when people outside of the Food and Drug Community start writing about potential problems, and when those problems translate into increased FDA enforcement actions, then Congress takes note and then (all of a sudden) laws get rewritten and regulations get passed and, the next thing you know, a segment of the industry is changed forever – or at least until the next time the government changes its mind.

Court Challenge Forces Firm to Change Color of its Generic Nexium Capsule

As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.