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.…
PDG™ is a pharmaceutical consultant serving drug sponsors around the world. On July 28, 2014, PDG™ published a chronology of events related to FDA’s proposed rule that would allow generics to use the CBE process to update their labeling with new safety information. Subsequently, RAPS Regulatory Focus (Alexander Gaffney, RAC, October 7, 2014) reported that…
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…
A recent study found that 78% of generic drug labels are inconsistent with the labeling of the reference listed drug (Duke et. Al 2012). While most of the differences were relatively minor, nearly one in ten were off by more than ten side effects. The researchers reviewed 9,105 labels representing over 1,500 drugs on DailyMed,…
As was previously promised, here are the transcripts (1 2) from FDA’s meeting entitled “Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs.” Contact us to find out how our experience can help your company expand your line of prescription and OTC products.
Recently, representatives from PDG attended the second meeting of the Central Florida chapter of RAPS. Featured was a presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media”. Mr. Lagrotte’s patient and thorough explanation of topics such as solicited vs.…