Martin Shimer Reviews Patents and Exclusivity

In a CDER Conversation piece entitled Patents and Exclusivities for Generic Drugs, Captain Martin Shimer, Deputy Direction, Division of Legal and Program Support, Office of Generic Drugs (OGD), briefly outlines various issues with patents, patent certifications and describes that various types of exclusivity that must be dealt with.

Patents are pretty straight forward,

Public Meeting on Balance of Hatch-Waxman – Some Observations

On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”.  The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”

While there were a number of presentations which can be accessed through the CDER web site once the transcript is published (see here) the themes of each presentation were very similar. 

MaPP Revision for Publication of Drug Product Approval Information

The Manual of Policies and Procedures  (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today.  While it’s     current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug approvals”, everyone interested in FDA product approval should become familiar with the contents of this MaPP last revised in 2014. 

Firm Decides to Remove Opana ER from the Market – What Do I Know?

On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations.

During the presentation, I was   asked by one participant what I thought the maker of Opana ER would do. 

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. 

OGD Senior Management Responds to Yesterday’s Post

On Monday we posted about an issue that was brought to our attention relative to OGD’s position on goal date assignment, or lack thereof, to an ANDA with unresolved eCTD problems.  We provided examples of some of the issues that firms were finding and we found that while there is merit to asking firms to fix their submissions if problems are found in the review,

CDER Outlines Proposed Guidance Documents it Proposes to Issue in 2016

On Friday January 22, CDER issued its yearly document outlining what Guidance documents it hopes to issue in 2016.  This yearly wish list is always a highlight of the beginning of every calendar year.  The document identifies either new guidance documents FDA hopes to release, as well as those it plans to revise.  This year the guidance agenda has 15 different categories and lists 102 different guidance documents it hopes to issue this year. 

Health Fraud – Dietary Supplements Warning Letters

 

A little more than a year ago, I gave a presentation on FDA hot topics.  One of the areas that was identified in my presentation was a potential for an increase in FDA enforcement efforts relative to dietary supplements, their claims, and the issues of new drug claims. I stumbled across a posting on the FDA webpage that gave examples of dietary supplement Warning Letters that were identified by FDA under the general classification of “Health Fraud”.

The Battle Over “Natural”

 

I usually cover drug and device issues in this blog, but today, I had some “food for thought” as I read a Federal Register Notice (here), in which the FDA is asking for comment on what the term “natural” should mean when used in food products. It seems that over the years many have weighed in on what the definition should be and some even believe that the term should be banned from use in the food industry because it has no standard or defined meaning.