New pregnancy labeling rules for prescription drugs took effect, June 30, 2015, marking the demise of the pregnancy categories (A, B, C, D, X), in use since 1979. The new rule ushers in what is expected to be an unprecedented era of inclusion regarding descriptive risk and benefit information. According to FDA, “a narrative structure…
Changes Being Effected (CBE) As pharmaceutical consultants, PDG has reported extensively on FDA’s Proposed Rule entitled Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. We even gave it our own abbreviated name: the “Generic CBE Rule”. We did so because the rule as originally proposed would allow generic manufacturers to implement safety…
As a pharmaceutical consultant, PDG understands that today’s drug manufacturers rely upon reformulation to prolong product lifecycles, protect against generic competition, supplement dwindling pipelines and otherwise differentiate/repurpose existing drug products. Indeed, novel formulations and drug delivery-based product development strategies have the potential of yielding higher returns on investment than comparable repositioning strategies. The Value of…
Rx-to-OTC switches and the related repositioning of pharmaceutical products from prescription (Rx) dispensing to the retail (over-the-counter or OTC) drug space represent huge market potential. A Strong Domestic OTC Market The U.S. market for OTCs more than doubled between 2007 and 2013 growing from $16 billion to $33 billion. [1] By the beginning of 2014,…
Orphan Drugs Offer Revenue and Profit Upside Many have speculated that the era of the blockbuster drug has ended. Indeed, 2014 marked the 6th year of a patent cliff in which a majority of U.S. blockbusters fell to generic competition. [1] Patent cliff notwithstanding, of the 43 global blockbusters on the market in 2012, 18…
FDA recently announced that Fixed-Combination Drugs (FCD) comprised of at least one NCE will be eligible for 5 years of exclusivity. [1] FDA explained that it has revised its interpretation of the term “drug” for the purpose of exclusivity eligibility from “drug product” to “drug substance”. Therefore, the 5-year NCE exclusivity determination will apply to…
In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the changes being effected (CBE) process. While the comment period had earlier been extended, there was no corresponding extension in the scheduled publication date of December 2014.…
FDA recently granted a therapeutic equivalence (TE) rating of AB to a “generic” version of an innovator product approved via a 505b2 NDA. In July 2014, FDA granted the AB rating to Perrigo’s 1% testosterone gel drug product (NDA 203098) approved in January 2013, and a BX rating to Teva’s (NDA 202763) approved in February 2012. …
As pharmaceutical consultants, PDG devotes considerable resources to both brand & generic drug safety surveillance and labeling issues. As such, we have followed with great interest the proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” For ease of reference, we’re going to begin to refer to it as the…
FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to develop and implement safety-related changes to their labeling. If/when implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. Prior to this new rule generic companies could only change…