Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, last year saw a marked increase not only in the number of advisory committee meetings, but in the proportion of recommendations for approval. FDA currently has over 30 advisory committees providing the agency with access to advice from experts outside of government to help in evaluating new therapies for safety and efficacy as well as defining policy positio ..read more

Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency would vary much in terms of volume or style from year to year, but that is not the case. How Many? This year the agency issued 190 releases, which is a substantial cutback from recent years in terms of sheer numbers. The last time the agency issued less than 200 releases to the public was back in 2017. There was a marked pickup during that when FDA was overseen by Dr. Scott Gottlieb who introduced frequent rel ..read more

Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional content regarding the cancer treatment KISQALI(r) (ribociclib). The communications vehicle that was the subject of the letter was a Direct-to-Consumer (DTC) television advertisement that had been submitted for agency review. Before getting to the specifics of this particular letter, a look at how it stacks up against recent enforcement. Aside from being the f ..read more

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Now, with no more AdComms scheduled for 2023 – and it being highly unlikely that any will be – it is that time of year to do just that. What we find is that it was somewhat of a milestone year in terms of volume, outcomes and style. Virtual Meetings. Let’s start with the obvious. We are still in virtual meeting territory. At the outset of the COVID-19 pandemic, FDA began conducting ..read more

While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the total number of letters issued by OPDP to five this year – one Warning Letter that came out in August respecting a sales aid used in promoting a treatment for COPD, and 4 untitled letters – one in June, one in August, and now two in October. The first letter posted this week was issued on October 31 and was in sole relation to a direct-to-consumer brochure that containe ..read more

FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new advisory committees all that often, making it a notable development in more than one respect. FDA stated in the agency’s press release that the committee’s subject matter jurisdiction will include helping the agency explore and assess issues regarding artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics ..read more

FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence to a medication may have on the resulting preference for a medicine. OPDP regularly conducts research on a wide-ranging scale to help define the agency’s perspective on how various conditions might impact a target audience of a promotional communication. In particular, the agency states in the Federal Register notice that it has previously conducted research around market claims that discuss characteri ..read more

Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up – at least in terms of the volume of activity. First let’s look at the approval of new molecular entities, and then at the number of Advisory Committee meetings being held, and compare them to the first half of 2022. New Molecular Entity (NME) Approvals – These approvals are an important indicator of innovation coming from test tube to patients. Last year was not ..read more

For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came in the form of an Untitled Letter (NOV) sent to a company regarding a paid social media posting. Enforcement this year was non-existent until June when the agency posted its first letter in a year. This week’s action makes a total of three letters sent this year, all within a three-month period. The Untitled Letter posted this week involved an oral birth control pill which has a ..read more

In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June FDA posted an Untitled Letter, the first regulatory action letter in a year, reported on here regarding a website communication. This month FDA posted another letter, this one a Warning Letter involving a Sales Aid. This second letter of 2023 makes a total of six letters for the combined years of 2022-2023, two of which were Warning Letters and four of which w ..read more